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Regorafenib/Nivolumab Proof Of Concept Suggested In Third-Line, Refractory HCC
28 March 2021
According to the preliminary results from a phase 2 study, half of all patients with Hepatocellular Carcinoma (HCC) treated with the combination of regorafenib (Stivarga) and nivolumab (Opdivo) achieved disease control. The study was led by Yasmina Ben Merabet, MD, of the Hepato-Biliary Center at the Paul-Brousse Hospital in Villejuif, France. Typically, patients with HCC who progress after more than 2 lines of chemotherapy have a very poor prognosis. This study wanted to explore the potential for this combination in HCC patients in the third-line setting or beyond. Patients received the combination treatment for a median of 5 months. The overall response rate (ORR) was 30%. The median time to response was 2.5 months and the median duration of disease control was 6 months.

Study In ‘Nature’ Concludes Immunotherapy Is Less Efficient In Non-Viral Liver Cancer
25 March 2021
A team of researchers from the University of Barcelona (UB) and August Pi Sunyer Biomedical Research Institute (Clínic-IDIBAPS), conducted a study which showed patients with Hepatocellular Carcinoma (HCC) who undergo a type of immunotherapy responded worse to the treatment when the tumor is caused by a fatty liver or alcohol abuse. Immunotherapy can have clinical benefits in advanced phases of the disease based on previous findings of the combination treatment of bevacizumab and atezolizumab. However, the efficiency of immunotherapy can be affected by the cause of the tumor since the etiology will condition the type of immune response. “We need biomarkers that correlate with the response to treatment and that enable us to classify patients who can benefit from it”, states Josep M. Llovet.

Genetron Health Releases New Data Results Of HCCscreen™ For Liver Cancer Early Screening In China
24 March 2021
Genetron has released new study information regarding their HCCscreen, a blood-based early screening test for Hepatocellular Carcinoma (HCC). The multi-center prospective HCCscreen Investigational Study (HIT), is a collaboration between Genetron Health and the National Cancer Center China that started in 2019. Results showed that HCCscreen achieved 88% sensitivity and 93% specificity, compared with 71% sensitivity and 95% specificity, respectively, by ultrasound plus alpha-fetoprotein (AFP). HCCscreen is powered by Genetron's proprietary Mutation Capsule technology, which enables the detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens. “Overall, HCCscreenTM continues to be a leading liquid-biopsy early detection assay in Hepatocellular Carcinoma,” stated Sizhen Wang, co-founder and CEO of Genetron.

What to Know About Yervoy (Ipilimumab)
21 March 2021
Yervoy (ipilimumab) is an immunotherapy for the treatment of liver cancer. Yervoy works by targeting and inhibiting a protein receptor called cytotoxic T lymphocyte-associated protein 4 (CTLA-4), which prompts your immune system to attack cancer cells within your body. It may be given alone or in combination with another Opdivo (nivolumab). The combination of Yervoy and Opdivo is approved to treat HCC in patients who have been previously treated with Nexavar (sorafenib). Dosing for HCC is 3 mg/kg once every 3 weeks (in combination with Opdivo) for 4 combination doses, followed by Opdivo alone. The most common side effects associated with Yervoy include fatigue, diarrhea, and rash.

No Evidence That The Milk Protein Casein Causes Cancer
21 March 2021
According to an article based on a book titled “The China Study”, authored by biochemist and professor emeritus at Cornell University, T. Colin Campbell claiming that the milk protein casein is a carcinogen and “turns on cancer.” Campbell stated that he came to this conclusion after studying how the consumption of casein affected cancer development in animal models. However, this claim failed to mention the fact that the mice in these studies were previously infected with hepatitis B virus, which is a known risk factor for liver cancer. Cancer Research U.K. stated that “There is no good evidence that milk and dairy cause cancer” and that “There is good evidence that eating and drinking dairy products decreases the risk of bowel cancer.” Furthermore, casein is not recognized as a carcinogen, which is “an agent with the capacity to cause cancer in humans”, as defined by the U.S. National Institutes of Health. And is not on any lists of known and probable human carcinogens provided by the International Agency for Research on Cancer and the U.S. National Toxicology Program.

TheraSphere SIRT Received FDA Approval For Treatment Of Unresectable HCC
18 March 2021
TheraSphere Y-90 Glass Microspheres, developed by Boston Scientific Corporation for the treatment of Hepatocellular Carcinoma (HCC), has been approved by the FDA. This selective internal radiation therapy, or SIRT, is made up of millions of microscopic glass beads containing radioactive yttrium (Y-90) for direct delivery to cancer cells within the liver, using a catheter for minimal exposure to healthy tissue. This decision was based on the results of the LEGACY study, which looked at efficacy and safety. The results showed the median overall survival (OS) in the intent-to-treat population was 57.9 months and the rate of OS at 3 years was 86.6%. Liver function as determined by levels of albumin and bilirubin were maintained for 92.9% and 85.3% of patients, respectively. “The FDA approval and the recent NICE [National Institute for Health and Care Excellence] recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally,” stated Peter Pattison, president of Interventional Oncology, Peripheral Interventions at Boston Scientific.

FDA Approves TheraSphere Y-90 Glass Microspheres For Unresectable HCC
18 March 2021
Based on the results of the LEGACY study, the FDA has approved TheraSphere yttrium-90 (Y-90) glass microspheres for the treatment of patients with unresectable Hepatocellular Carcinoma (HCC). In the study, TheraSphere microspheres served as a suitable neoadjuvant therapy before transplant or resection. The median overall survival was 57.9 months and the overall survival rate at 3 years was 86.6%. The primary endpoint of the study was objective response rate (ORR) and duration of response (DOR). Among 162 patients the ORR was 72.2%, and of the 117 responders, 76.1% had a DOR of 6 months or more. Radioembolization with TheraSphere can be performed as an outpatient procedure and has been recommended for use by the National Institute for Health and Care Excellence (NICE) for the treatment of patients with HCC.

As FDA Review Approaches, Finn Reflects On The Utility of Pembrolizumab, Nivolumab In HCC
17 March 2021
OncLive interviews with Richard S. Finn, MD professor of clinical medicine in the Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine at the University of California, Los Angeles (UCLA). Finn explains that while Pembrolizumab (Keytruda) and nivolumab (Opdivo) did not meet the endpoints of the confirmatory KEYNOTE-240 and CheckMate-459 trials, respectively, they still represent valuable second-line treatment options for patients with Hepatocellular Carcinoma (HCC). Finn also states that nivolumab and pembrolizumab have very favorable safety profiles. Finn was the lead author on the KEYNOTE-240 study for pembrolizumab monotherapy after sorafenib in patients with advanced HCC. The study concluded with a response rate of 18%.

Dr. Pillai On Sequential Treatment In HCC
15 March 2021
Anjana Pillai, MD, associate professor and medical director of the Liver Tumor Program, at the University of Chicago, discusses sequential treatment in Hepatocellular Carcinoma (HCC). Pillai explains that the treatment landscape for HCC is moving toward sequential treatment, as more first-line options are approved by the FDA. Determining which first-line therapies should be selected for each patient is crucial. However, several combination therapies may be utilized in the first-line setting, which will prompt the question of which approach should be selected for subsequent treatment, Pillai explains. Future data will help to determine which treatments should be used subsequently for patients whose disease progresses.

Liver Cancer Symptoms: Pain Near the Right Shoulder Blade Could Be A Sign Of The Disease
15 March 2021
Symptoms of liver cancer often do not appear until the later stages of the disease. While a lump in the right side of your abdomen, where the liver is located, is one of the main symptoms, other parts of the body can be affected. One of the other most common symptoms is pain near the right shoulder blade and may extend into the back. This happens because The tumor can irritate nerves that tell your brain the pain is coming from your shoulder blade when it is coming from the liver. According to the NHS website for England (www.nhs.uk), other liver cancer symptoms include jaundice skin or eyes, loss of appetite, and itchy skin.

The Non-Alcoholic Fatty Liver Cause Of Hepatocellular Carcinoma
11 March 2021
There are four main causes of Hepatocellular Carcinoma (HCC): hepatitis B, hepatitis C, excessive alcohol consumption, and nonalcoholic fatty liver disease (NAFLD) leading to nonalcoholic steatohepatitis (NASH). Steatosis is the first and largely symptomless stage of NAFLD. Once a person develops NASH, they have liver damage that takes the form of inflammation and cell death. Approximately 25% of adults in the US have NAFLD. Cirrhosis of the liver is the final stage of damage, with often significant loss of capability, as well as serious health effects, including the potential for complete liver failure. Between 5% and 15% of these patients develop HCC. Blue Faery provides free and clinically accurate materials for patients and caregivers, including the HCC patient education brochure the Blue Faery HCC staging discussion pad, and the Patient Resource Guide for Liver Cancer which is a 20-page booklet with explanations and resources.

People With HIV And Hepatitis B Should Have Ongoing Monitoring For Liver Cancer
11 March 2021
According to recent research, people with HIV and hepatitis B are at high risk for developing Hepatocellular Carcinoma (HCC) despite antiviral treatment and should undergo regular monitoring for liver cancer. “Our findings underscore that antiviral therapy reduces but does not eliminate the risk of HCC,” Dr. H. Nina Kim of the University of Washington. Kim and the team analyzed the medical history of 8354 patients. Looking at the full study population, there were 115 new cases of HCC or 1.8 per 1000 person-years. The researchers concluded that this study is the first to show that any level of hepatitis B virus in the blood is associated with increased HCC risk in a large, racially diverse cohort outside of Asia. Hepatitis B is among the leading causes of liver cancer worldwide.

Microwave Ablation Burns Away Liver Tumors
10 March 2021
The most effective treatment for liver cancer tumors is resection, or the operation of cutting the tumor and surrounding liver out of the body. This is a very serious operation and can have a long recovery time for patients. Cleveland Clinic is the first hospital in the world to use a new treatment recently approved by the FDA. It is an ablation technology that delivers 150-watts of microwave energy with a single needle. “We insert this special camera, that we can look inside,” explains Eren Berber, MD, MBA, director of surgical liver tumor ablation at Cleveland Clinic. Berber is a world leader in advanced laparoscopic ablation technologies and says that this treatment’s benefits include better recoveries, less pain, and a quicker return to normal life. He further explains that the camera, and laparoscopic ultrasound, are used to examine the liver and expose the tumor for microwave ablation. “Through a very small incision, a couple of millimeters, we introduce our ablation needle under the ultrasound guide,” described Dr. Berber. Then, the microwave generator is used to deliver immense heat to burn and destroy the tumor.

Looking Beyond Atezolizumab/Bevacizumab For The Treatment Of HCC
10 March 2021
There have been many clinical trials for treatments for Hepatocellular Carcinoma (HCC) which have compared effectiveness with the current standard of care using sorafenib (Nexavar). The current FDA-approved treatment for HCC is the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin). The phase 3 CheckMate 459 compared sorafenib with nivolumab (Opdivo), an immune checkpoint inhibitor. The median overall survival (OS) achieved with nivolumab was 16.4 months, longer than that of sorafenib which was 14.8 months. Laura Goff, MD, associate professor of Medicine at Vanderbilt-Ingram Cancer Center believes that the combination of atezolizumab plus bevacizumab is the clear winner in the first-line setting right now.

St George Hospital Researchers Make Liver Cancer Breakthrough
10 March 2021
The Sir Owen Glenn Liver Research Group based at the University of NSW Microbiome Research Centre at St George Hospital has found a way to predict a person's risk of developing liver cancer. The study was overseen by Associate Professor Amany Zekry and Professor Emad El-Omar. The team recruited 90 adult patients, two-thirds of whom had just been diagnosed with either non-alcoholic fatty liver-related liver cancer or cirrhosis. They discovered that the gut microbiome, the group of microorganisms living in our digestive tracts, can modulate the immune response in liver cancer patients with non-alcoholic fatty liver disease in a way that promotes cancer's survival.

How Real-World Regorafenib Dosing Correlates With Prior Sorafenib Treatment In HCC
9 March 2021
Richard Finn, MD, an oncologist at the UCLA Jonsson Comprehensive Cancer Center, discusses the current results of the REFINE Study. This study tests the real-world dosing of regorafenib (Stivarga) in patients with Hepatocellular Carcinoma (HCC). All of the patients in the study were previously treated with sorafenib (Nexavar). Patients were administered 80 mg to 120 mg of regorafenib daily. Finn noted that dosing seemed to be based on the prior sorafenib dose. Survival in the group was about 13 months. Adverse events were similar to those observed in the RESORCE study, and according to Finn, the safety profiles were similar regardless of the dose. Dose de-escalation was also determined to be related to prior sorafenib.

How Summer On The Lake May Impact Your Liver
9 March 2021
As summer begins, algae also begin to grow, unleashing a green scum across bodies of water and toxins that can affect the health of anyone exposed to too much. Microcystin-LR is the most common and the most potent toxin produced by freshwater blue-green algae. It was first identified as a potent liver toxin in the 1980s and has since been linked to liver damage and cancer. Pharmaceutical Sciences Assistant Professor John Clarke reported from his lab that when a healthy liver was exposed to microcystin it caused fibrosis, which then repaired itself. However, when a NAFLD liver was exposed to the same toxin the fibrosis stayed. When fibrosis becomes severe and permanent, the liver disease has progressed to a stage called cirrhosis. Both fibrosis and cirrhosis increase the risk of developing Hepatocellular Carcinoma (HCC).

Doctors Debate: Is Systemic Or Liver-Directed Therapy Best For Hepatocellular Carcinoma?
5 March 2021
There are currently many treatments for Hepatocellular Carcinoma (HCC), including surgery, transplant, liver-directed therapy, and systemic therapy. In a review of cases and clinical trials in HCC, it was shown that treatment strategies that were multi-modal achieved better resection rates in surgery, more successful transplants, and longer survival following treatment compared with studies that used one form of therapy over the other. Sunyoung S. Lee, MD, Ph.D., a gastrointestinal medical oncologist and faculty member in the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center in Houston, stated “The most important point is that HCC needs multidisciplinary care, and medical oncologists need to know when to add liver-directed therapy, and interventional radiologists or radiation oncologists need to know the indication when systemic therapy needs to be added. More and more data suggest that multidisciplinary care is more beneficial in HCC. This is the key takeaway.”

TGH Begins Trial of New Device Created To Destroy Tumors Without Surgery
5 March 2021
Physicians at Tampa General conducted the first use of a novel device called HistoSonics System in January using a new technique called Histotripsy which uses ultrasound waves in non-invasive surgeries to remove tumors. Patients who have liver tumors and have been deemed inoperable can qualify to take part in the #HOPE4LIVER trial. the Histotripsy device uses its robotic arm to perform the ablation of the tumor using ultrasound waves. The device uses a robotic arm to perform the ablation of the tumor. The procedure enables physicians to target a specific area precisely within 1/16th of an inch causing air bubbles to form and rupture the cells without using any type of incision. The debris is then removed.

Innovative, Non-Invasive Technologies Advanced Earlier Detection & Monitoring Of Liver Disease
5 March 2021
FibroScan® is a pain-free, non-invasive examination of the liver. It can analyze and provide information regarding liver stiffness and fat scores in a single 10-minute procedure. Since the scan produces numeric measurements and not images, it allows for simplified interpretation and consistency of measurement for monitoring changes in liver tissue over time. People are becoming more aware of the prevalence and costs associated with under-diagnosed liver disease. Non-alcoholic steatohepatitis (NASH), and the more severe form, non-alcoholic fatty liver disease (NAFLD), is a potentially progressive liver disease that can lead to cirrhosis and Hepatocellular Carcinoma (HCC). Estimates show that roughly 357 million people will have NASH globally by 2030.

Study Shows Simple Blood Test Could Detect Liver Injury Earlier
5 March 2021
The current standard for monitoring and diagnosing liver disease is with a liver biopsy, which is invasive and can be painful or cause complications. A non-invasive procedure used to monitor liver function is blood tests that record levels of certain enzymes and proteins in the blood, such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which are released by liver cells, or hepatocytes, when the organ is damaged. Physicians also can monitor liver function noninvasively with tests that record levels of certain enzymes and proteins in the blood, such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which are released by liver cells, or hepatocytes, when the organ is damaged. In one of the studies, Zheng and his colleagues focused on a chemical called glutathione, which is the master antioxidant produced by the liver.

What Is Stage 4 Liver Cancer?
5 March 2021
There are four stages of liver cancer, also called Hepatocellular Carcinoma (or HCC). In the fourth and most advanced stage, a tumor that began in the liver has spread to lymph nodes and other organs. Liver cancer is more common among men of Black, Native American, Hispanic, and Asian or Pacific Islander descent. Some of the signs and symptoms of liver cancer include abdominal swelling, loss of appetite, fluid in the abdomen and jaundice. Screening for the stage of liver cancer can help determine how far cancer has spread and what treatments would have a greater effect. The substages of liver cancer are based on tumor size and how much it has spread to other parts of the body.

NICE Recommends New Advanced Liver Cancer Treatment
2 March 2021
NICE issued final draft guidance on a cancer treatment called selective internal radiation therapy (SIRT) as an option for treating Hepatocellular Carcinoma or HCC. SIRT is a way of giving radiation treatment for cancer via tiny radioactive beads (called microspheres) which are injected into the artery supplying blood to the tumor via a catheter from the femoral artery. The draft guidance recommends the use of two particular microsphere products for treating advanced liver cancer which can’t be surgically removed and when a procedure to cut off the blood supply to the tumor isn’t appropriate. In 2017, there were 4,975 people diagnosed with HCC, of whom around 1,780 would have been eligible to receive treatment with SIRT.

Implanted Chemotherapy Device Has Kept Her Cancer In Check For More Than A Year
1 March 2021
Liver surgeon Clifford Cho, M.D. implanted a device known as a hepatic artery infusion pump, designed to deliver powerful chemotherapy directly to the liver of one of his patients. Cho says. “It allows us to be much more aggressive in delivering chemotherapy directly into the liver.” The use of the pump, which is about the size and shape of a hockey puck, was developed in Michigan in the late 1970s and early 1980s by William Ensminger, M.D., Ph.D., and his colleagues. Because the liver is so good at breaking down the powerful chemotherapy agent fluorodeoxyuridine, or FUDR, it can be delivered at levels that would be overwhelmingly toxic if given throughout the whole body like most chemotherapies, explains Ensminger.

Liver Cancer: What Are The Best Treatment Available? Know What Increases Your Risk of The Deadly Disease
1 March 2021
Dr. Ravi Mohanka, Chief Surgeon and Head of Department, Transplant and HPB Surgery, Global Hospital, Mumbai, discussed life-saving treatments. High alcohol consumption, a family history of liver cancer, type 2 diabetes and liver cirrhosis are all factors that can lead to liver cancer. Liver cancer occurs when old and damaged liver cells overgrow and keep multiplying instead of dying. The treatment to deal with liver cancer will depend on the type, stage, and location of your tumor. Symptoms of liver cancer include abdominal pain, jaundice, nausea, vomiting, fatigue, and unintentional weight loss. Ablation therapy can be used -this is when the doctor will opt for heat, laser, or alcohol injection to kill the cancerous cells.

Personalized Radioembolization Improves OS Vs Standard Dosing In Advanced HCC
1 March 2021
According to the results of the phase 2 DOSISPHERE-01 trial, Yttrium-90 (Y-90) glass microspheres (TheraSphere) administered in a personalized, dosimetric approach demonstrated a 16-month improvement in overall survival (OS) compared with a standard dosimetric approach in patients with unresectable Hepatocellular Carcinoma (HCC). Dosimetry is the determination and measurement of the amount or dosage of radiation absorbed by a substance or living organism using a dosimeter. The study included 56 patients. The median OS was 26.6 months with personalized dosimetry, versus 10.7 months with standard dosimetry. The objective response rate (ORR) of index lesions was 71.4% with the personalized approach versus 35.7% with the standard approach, thus meeting the primary endpoint of the study.

Q&A: Longest Survival Among HCC Patients Seen With ‘Breakthrough’ Drug Combination
26 February 2021
Richard Finn, MD, discussed the results from the IMbrave150 study, which observed patients with Hepatocellular Carcinoma treated with combination therapy of atezolizumab and bevacizumab. Atezolizumab is an immunotherapy drug and monoclonal antibody, while bevacizumab is another monoclonal antibody against the vascular endothelial growth factor (VEGF). The study included over 500 patients. At 12 months, survival was 67.2% in the combination group, compared with 54.6% sorafenib-alone group. At 18 months, survival was 52% with atezolizumab plus bevacizumab vs. 40% with sorafenib. According to Finn, “This doublet is probably now the standard of care for patients who have advanced liver cancer.”

Why Is Liver Cancer More Lethal For Black Patients?
26 Feb 2021
According to a recent study, although black patients with hepatitis C have been shown to develop aggressive liver cancer sooner than people in other racial groups, current screening guidelines may not be broad enough to catch these cases early. A team of researchers reviewed 1200 medical records at Mount Sinai Medical Center, of which 390 were black patients. At the time that their liver cancer was diagnosed, Black people with hepatitis C had larger liver cancers with more aggressive features, yet little to no scarring. Liver damage and scarring are typically indicators of the necessity for liver cancer screening. The study author Dr. Umut Sarpel states, “If you are Black and have hepatitis C, let's not wait for cirrhosis to screen for liver cancer.”

Zhejiang University: ZJU Scientists Report Advances In Hepatocellular Carcinoma
25 February 2021
According to the Global Cancer Report, the number of liver cancer cases in China accounts for over 46 percent of the total number of cases worldwide. The 5‐year survival rate varies from 14% to 18%
To overcome drug resistance, the research team led by Prof. XU Xiao from the Affiliated Hangzhou First People’s Hospital of the Zhejiang University School of Medicine and the research team led by Prof. SHEN Youqing from the Zhejiang University College of Chemical and Biological Engineering developed a galactose‐decorated lipopolyplex (Gal‐SLP) as an HCC‐targeting self‐activated cascade‐responsive nanoplatforms to co‐delivery sorafenib and USP22 shRNA (shUSP22) for synergetic HCC therapy.

Berry Oncology Announces Novel Diagnostic Method for Liver Cancer Achieved Greater Accuracy and Sensitivity
24 February 2021
Berry Oncology Corporation has published the results of a recent clinical trial led separately by Prof. Hong-Yang Wang of the National Center for Liver Cancer, Prof. Jin-Lin Hou of Nanfang Hospital, Southern Medical University and Dr. Lin Wu and Dr. Jian Bai of Berry Oncology. The study focused on the effectiveness of a new diagnostic method for detecting Hepatocellular Carcinoma (HCC) in patients with liver cirrhosis, demonstrating a greater level of accuracy and sensitivity compared to existing screening methods. The new diagnostic model is called HIFI and achieved a sensitivity of 95.42% which is a higher accuracy in differentiating HCC from liver cirrhosis than existing diagnosis tests measuring AFP or PIVKA-II. The method was also able to detect signs of liver cancer with 93.9% accuracy among individuals that had tested negative using an AFP test.

ZJU Scientists Report Advances In Hepatocellular Carcinoma
24 February 2021
According to the Global Cancer Report, the number of liver cancer cases in China accounts for 46.7% of the total number of cases all over the world. To overcome drug resistance and reverse cancer stemness, the research team led by Prof. XU Xiao from the Affiliated Hangzhou First People’s Hospital of the Zhejiang University School of Medicine and the research team led by Prof. SHEN Youqing from the Zhejiang University College of Chemical and Biological Engineering, have developed a galactose‐decorated lipopolyplex (Gal‐SLP) as an HCC‐targeting self‐activated cascade‐responsive nanoplatform to co‐delivery sorafenib and USP22 shRNA (shUSP22) for synergetic HCC therapy. “Combination and precision cancer therapy is undoubtedly the direction of future development,” XU Xiao said.

Can-Fite BioPharma (CANF) New Positive Data From Its Liver Cancer Phase II Clinical Study With Namodenoson
22 February 2021
Can-Fite BioPharma recently announced new data from the Phase II advanced liver cancer study including overall survival of nearly 4 years in two patients who are being treated with namodenoson. Namodenoson is a small orally bio-available drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second-line treatment for Hepatocellular Carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.

Cancer Control: Non-DNA Changes Induce Metabolism Variations In Hepatocellular Carcinomas
22 February 2021
Hepatocellular Carcinoma (HCC) is one of the most dreadful cancers and is known to be highly malignant and invasive with a high recurrence rate and drug-resistant phenotype. Changes in cell programming allow these cells to grow at an uncontrolled rate, thus forming the cancer mass. N6-methyladenosine (m6A) methylation, a type of RNA modification, remains the most abundant epigenetic (non-DNA related) modification. A group of researchers from Fudan University, China led by Prof. Lun-Xiu Qin questioned whether m6A modification can influence the behavior of HCC and help predict prognosis. The team developed a new m6A score to quantify how much modification happened in HCC, the association with other alterations that contribute to HCC pathogenesis, and the response to treatment with sorafenib.

Neoadjuvant Cabozantinib/Nivolumab Feasible For Borderline Resectable Patients With HCC
19 February 2021
According to a research study, the combination of neoadjuvant cabozantinib (Cabometyx) and nivolumab (Opdivo) in patients with Hepatocellular Carcinoma (HCC) was found to be a possible treatment with potential long-term benefits. The results from the phase I study which looked at 15 patients with borderline resectable or locally advanced HCC found that five resected patients achieved either major or complete pathologic responses after 8 weeks of therapy with the combination of cabozantinib and nivolumab before surgery. At a median follow-up of 1 year, 4 out of the 5 patients with pathologic responses did not have disease recurrence. “Encouragingly, the patients who had major pathologic responses had outstanding disease-free survival, with all of these patients having disease-free survival of greater than 200 days after surgery, whereas patients who did not achieve major pathologic responses had a high rate of disease recurrence quite early on,” said Mark Yarchoan, MD.

Dr. Mody On Progress Made With Y-90 In Hepatocellular Carcinoma
18 February 2021
Kabir Mody, MD, an oncology specialist at Mayo Clinic, discusses new approaches with yttrium-90 (Y-90) glass microspheres (TheraSphere) in Hepatocellular Carcinoma (HCC) as shown in the retrospective LEGACY study. Y-90 glass microspheres are being explored as neoadjuvant therapy in patients with advanced HCC, to be administered before primary cancer treatment (such as surgery) to enhance the outcome of primary treatment. Mody concludes that notably, this is a new development for this modality, and this underscores the progress that has been made with Y-90 in the past 10-15 years.

Abivax’s Phase I/II ABX196 In Second-Line HCC Draws Odds If Front-Line Shake-Up Negatively Impacts Its Success Trajectory
18 February 2021
Based on the current results of the Phase I/II trial of ABX196 in a second-line setting for patients with Hepatocellular Carcinoma (HCC) have researchers questioning sequencing. Researchers wonder if using ABX196 as a first-line treatment would harm its immediate- and long-term success potential. While ABX196 has a promising mechanism backed by preclinical data, its invariant natural killer T (iNKT) cell agonist approach is yet to prove its worth in oncology, according to experts. Due to a more effective first-line option, patients may have delayed progression to later-line therapies, meaning this could defer second-line therapy use. However, there are many available and currently therapies under investigation that would be possible effective second-line treatments.

Never-Before-Seen Antibody Binding, Informing Liver Cancer, Antibody Design
17 February 2021
A research team led by Salk scientists defined how antibodies can recognize a compound called phosphohistidine, which is highly unstable and has been found to play a central role in liver cancer. “We are excited that these new antibody structures reveal novel principles of antigen-binding. Now we can redesign these antibodies and engineer their properties to make them more efficient,” says Tony Hunter, Renato Dulbecco Chair and American Cancer Society Professor at Salk and the paper's senior author. The two types of antibody crystal structures solved by the team showed exactly how different amino acids are arranged around the phosphohistidine and bind to it tightly. They also uncovered, at a structural level, how the two types of antibodies recognize different forms of phosphohistidine, which will allow scientists to engineer improved antibodies in the future.

New Standard Of Care In Hepatocellular Carcinoma Shifts The Treatment Paradigm To A Grey Area
17 February 2021
After the FDA approved Roche’s Avastin (bevacizumab) + Tecentriq (atezolizumab) in May 2020, the combination replaced the prior standard of care Nexavar (sorafenib) as a first-line treatment for HCC. This resulted in uncertain sequencing where there are no data available for second-line and third-line treatments. There are several pipeline drugs in Phase III clinical development with a variety of mechanisms of action in adjuvant settings, using immuno-oncology monotherapies in addition to Avastin. Other current trials are combining trans-arterial chemoembolization (TACE) with immuno-oncology monotherapies. The concern in sequencing does not limit first-line, second-line, or third-line treatments of advanced-stage HCC, but it expands from earlier stages through the later stages of HCC.

Incidence Of Liver Cancer Increases Significantly Among People With HIV
17 February 2021
According to a recent study, Hepatocellular Carcinoma (HCC) rates among people with HIV increased significantly from 1996 to 2015. “People with HIV had more than 3 times higher [incidence rate (IR)] for HCC compared with the U.S. general population rates … demonstrating the increased relative burden of HCC among people with HIV,” explained Jing Sun, MD, Ph.D., assistant scientist at Johns Hopkins Bloomberg School of Public Health. Sun and his team conducted a cohort study of 109,283 people with HIV. Of the people with HIV, 19.5% were coinfected with hepatitis C, 5.8% were coinfected with hepatitis B and 1.9% had hepatitis C, hepatitis B and HIV. Additionally, 451 patients were diagnosed with HCC by 2015. The team concluded that people with HIV coinfected with viral hepatitis had a higher risk for HCC.

Gentle Stroll On Treadmill Helps Prevent Liver Cancer
16 February 2021
team of scientists at Newcastle University showed that aerobic exercise in mice reduced the levels of inflammation in the liver that develops with aging. This exercise was able to reverse liver damage and prevent tumors from developing. The team also found that the exercised mice were still physically active as they age, which is an indicator of general well-being. Statistics show that liver cancer incidence rates have increased by three-fifths in the UK in the last decade. As people age, their body begins to lose control over the immune system, which can lead to high levels of inflammation. Tissue damage is caused when these high levels persist over a long period, which can lead to the development of cancer.

Challenges When Treating Patients With Hepatocellular Carcinoma
11 February 2021
Al B. Benson, MD, professor of Medicine, Hematology and Oncology, Northwestern University Feinberg School of Medicine, addresses concerns with treating a patient with Hepatocellular Carcinoma (HCC) and the best results. Multidisciplinary determination of disease is critical, according to Benson. While transplantation is the best option for patients, while they wait for a liver, the best management for those patients, whether it is bridge therapy or other approaches to keep patient’s disease stable, is still being debated. He further explains that much of the research in this setting has been for those with Child-Pugh A disease, while many patients with HCC have more severe cirrhosis, with Child-Pugh B or C disease.

Ionic Liquid Formulation Uniformly Delivers Chemotherapy To Tumors While Destroying Cancerous Tissue
10 February 2021
A team of researchers at the Mayo Clinic led by Rahmi Oklu, M.D., Ph.D., a vascular and interventional radiologist, in collaboration with Samir Mitragotri, Ph.D., of Harvard University, have published a report in which they describe to have found the development of a new ionic liquid formulation that killed cancer cells and allowed the uniform distribution of a chemotherapy drug into liver tumors and other solid tumors in the lab. Dr. Oklu explains that uniform drug delivery to tumors is often challenging, and higher drug doses are often used to encourage drug delivery into the tumor, but these higher doses could lead to significant toxicity. Dr. Oklu and his colleagues developed an ionic liquid, essentially salt in a liquid state, as an alternative way to deliver drugs into tumors through ultrasound-guided needle injection. Once injected the ionic liquid deposited the chemotherapy drugs uniformly, killing the cancer cells as the liquid engulfed the tumors.

Genetron Health’s Early Liver Cancer Screening Research Results Included In First Prevention And Treatment Guidelines For Patients In China
9 February 2021
The “Chinese Anti-Cancer Association Guidelines for Patients with Primary Liver Cancer” (the “Guidelines”), issued by the Chinese Anti-Cancer Association, are the first national-level patient-oriented full-process guidelines for liver cancer prevention and treatment in China. The Guidelines emphasized that “Liquid biopsies based on circulating tumor DNA (ctDNA) have shown significant value in early screening for liver cancer. The combined detection of mutation and methylation, in combination with traditional protein biomarkers, can achieve better screening results.” Several oncology experts in China, including Academician Fan Jia from the Chinese Academy of Sciences, were involved in developing these Guidelines, advising patients with anti-cancer tactics spanning prevention, diagnosis, and treatment to rehabilitation.

Drug Combo May Boost Survival For Tough-To-Treat Liver Cancers
9 February 2021
Based on a new study, the combination treatment of bevacizumab (Avastin) and atezolizumab (Tecentriq) can extend liver cancer patients' lives. Avastin is administered intravenously and starves tumors by preventing new blood vessel growth. Tecentriq, also administered intravenously, is an immune checkpoint inhibitor, which can seek and destroy tumors. The researchers found that the median survival among Avastin/Tecentriq patients was just over 19 months, compared with 13 months among patients given sorafenib (Nexavar). After 18 months, 52% of patients on the combination were still alive, versus 40% of sorafenib patients. Further, 30% of combination patients showed tumor shrinkage, and in 8% of patients, the tumors were no longer detectable. The lead researcher was Dr. Richard Finn, professor at the University of California, Los Angeles Geffen School of Medicine.

Innovent Announces First Patient Dosed In Phase III Pivotal Trial Of IBI310 (CTLA-4) Combined With TYVYT® For The Treatment Of First-Line Advanced Hepatocellular Carcinoma
8 February 2021
The first patient has been successfully enrolled and dosed in a randomized, open-label, phase III clinical study evaluating IBI310 in combination with TYVYT® for the first-line treatment of a patient with advanced Hepatocellular Carcinoma (HCC). Innovent Biologics, Inc. has developed IBI310, a genetically engineered, fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor developed by Innovent and Eli Lilly and Company. This study involves more than 50 clinical centers and is led by Professor Fan Jia from Zhongshan Hospital of Fudan University, and Professor Qin Shukui from Affiliated Jinling Hospital, Medical School of Nanjing University.

RDI And Ammonia Levels May Predict Tolerability Of Lenvatinib In HCC
7 February 2021
Researchers have recently reported that positive responses were seen in patients with Hepatocellular Carcinoma (HCC) who maintained a high relative dose intensity (RDI) of 75% or greater of lenvatinib (Lenvima). The team analyzed 92 patients who achieved an RDI greater than or equal to 75%. The investigators noted that patients who had discontinued treatment because of adverse effects did not have overt hepatic encephalopathy, or a disease of the brain, however, serum ammonia levels were significantly related to both RDI and treatment discontinuation. They concluded that serum ammonia level may be useful for evaluating the liver function and predicting tolerability of lenvatinib treatment.

Drug ‘Breakthrough' Gives Longest-Ever Survival In Nonresectable Liver Cancer Patients
5 February 2021
The Imbrave150 clinical trial enrolled a total of 501 patients who had nonresectable HCC and had not previously been treated with systemic therapy. The trial focused on the combination therapy of Atezolizumab plus Bevacizumab. Atezolizumab is an immune checkpoint inhibitor drug, which helps the immune system find and destroy cancer. Bevacizumab is a targeted monoclonal antibody therapy that starves tumors of their blood supply and also enhances the immune effects of atezolizumab. The results of the trial showed the median overall survival (OS) was 19.2 months in patients treated with combination therapy versus 13.4 months for those treated with sorafenib alone.

Watch A New “Love Your Liver” Video Each Day In February!
4 February 2021
Blue Faery has begun a public awareness campaign entitled “Love Your Liver” and is posting daily liver-related videos along with simple actions you can take to protect yourself and your loved ones against liver disease. The daily videos are posted on LoveYourLiver.us, as well as Blue Faery’s YouTube channel. In the introductory video Andrea Wilson Woods, president and founder of Blue Faery, explains that the goal of Love Your Liver “is to educate the general public about liver disease and the causes of primary liver cancer.” Liver cancer is one of the deadliest cancers, yet it is highly preventable.

Eisai’s Liver Cancer Drug Lenvima Threatens Bayer’s Nexavar
4 February 2021
Currently, Bayer’s Nexavar is the top drug in the liver cancer treatment market, but Eisai’s Lenvima is edging closer. Lenvima’s prescriptions increased 132 percent in 2020 compared to a year earlier, while those of Nexavar dropped 31 percent. Lenvima has seen rapid growth in outpatient prescriptions after winning the indication for unresectable Hepatocellular Carcinoma in the first-line therapy in October 2019. Outpatient prescriptions of Lenvima rose significantly from 4.3 billion won in 2019 to about 10 billion won in 2020. The two treatments are almost tied in competition in the fourth quarter of 2020, with Nexavar’s outpatient prescriptions recording 2.36 billion won and Lenvima’s 2.39 billion won.

Liver Cancer ‘Signature’ In Gut Holds Clues To Cancer Risk
4 February 2021
According to researchers from the UNSW Microbiome Research Centre, a distinctive gut microbiome profile of a person with liver cancer linked to non-alcoholic fatty liver disease (NAFLD) could be the key to predicting someone’s risk of developing cancer. The team, led by Associate Professor Amany Zekry, of UNSW Medicine & Health, focused on the most common type of primary liver cancer, Hepatocellular Carcinoma (HCC). The team gathered 90 adult patients from several Sydney hospitals, two-thirds of whom had just been diagnosed with either NAFLD-related liver cancer or cirrhosis. They found that patients with NAFLD-related liver cancer had a distinctive and characteristic gut microbiome profile, which was different from those with liver disease generally.

Liver Cancer Still 2nd Major Cause Of Cancer Deaths In Korea
3 February 2021
According to a report by the Korean Association for the Study of Liver (KASL), the number of liver cancer deaths in Korea has been continuously increasing. Of the 10,655 patients, those with stage 3 liver cancer increased from 33.8 percent in 2008 to 39.4 percent in 2014. The five-year survival rate for a Korean liver cancer patient is 40 percent on average, making liver cancer the second most fatal cancer in the country. Hepatitis B took the largest share of liver cancer with 61.1 percent. KASL has designated Feb. 2 as Liver Cancer Day and published a request to people with risky symptoms to visit the hospital twice a year and take the liver ultrasound and blood serum AFP tests, to possibly detect liver cancer at an early stage.

Real-World Data For Lenvatinib Is Similar To Clinical Trials
1 February 2021
Yael Celermajer, MD, and team conducted independent research on patients with Hepatocellular Carcinoma (HCC), who were treated with lenvatinib (Lenvima) in a real-world setting. Their findings from a real-world safety and tolerability trial demonstrated that the agent’s safety profile was similar to that observed in the initial clinical trials with several adverse effects (AEs). Celermajer noted that hypothyroidism occurred more frequently in this real-world cohort (39%) and was independently associated with improved overall survival (OS) in lenvatinib-treated patients with HCC. Severe AEs included duodenal ulcer (2%), malignant hypertension (2%), anaphylaxis (2%), and sudden unexplained death after starting therapy (2%). At a median follow-up of 216 days, 59% of patients had ceased treatment with lenvatinib.

Can-Fite Announces Inhibition Of Liver Fibrosis By Cannabis Compounds In Preclinical Studies
1 February 2021
Can-Fite BioPharma has reported positive news on their pre-clinical studies demonstrating that CBD-rich T3/C15 cannabis fraction stimulates an inhibitory effect on liver fibrosis. Fibrosis of the liver occurs when injured or inflamed liver cells can no longer repair themselves. CBD-rich T3/C15 cannabis fraction suppressed the growth of LX-2 hepatic-stellate cells, the liver cell type mediating the development of fibrosis. This inhibitory response was stopped by an antagonist to the A3AR, demonstrating that the anti-fibrotic effect was mediated via the A3AR. Can-Fite has filed a patent application protecting its discovery of cannabinoid-based treatments where A3AR is overexpressed in several diseases including liver cancer.

Targeted RNA Nanoparticle Shows Early Promise As Treatment For Liver Cancer
1 February 2021
According to a new study, there may be a new targeted RNA nanoparticle designed to carry a chemotherapy drug along and provide an effective treatment for liver cancer. The study was conducted by a team of researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. The RNA nanoparticles carry a chemotherapeutic drug called Paclitaxel, and display molecules that target HCC cells. “Liver cells express drug exporter pumps that are used to remove chemotherapeutic drugs and detoxify the body. This renders the treatment with chemical drugs ineffective, and contributes to drug resistance,” says study leader and corresponding author Peixuan Guo, Ph.D., professor at Ohio State’s College of Pharmacy.

Redefining BCLC B, Intermediate-Stage HCC: Is There A Role For Combination Systemic Therapy
29 January 2021
Currently Hepatocellular Carcinoma (HCC) is a leading cause of cancer-related mortality worldwide with a rising incidence in the United States. BCLC B intermediate stage HCC is defined as patients with unresectable, liver-limited disease and preserved liver function. Locoregional therapies (LRTs), including arterially-directed therapies, are the mainstay of treatment and demonstrate an average survival benefit of approximately 2.5 years. The OPTIMIS trial, a real-world observational study, reported that a total of 507 patients became TACE ineligible during the study, and of those patients, 9% went on to receive systemic therapies like sorafenib (Nexavar). The study suggested that TACE may be overutilized. Another more recent therapy option is the combination of an anti–PD-L1 antibody atezolizumab (Tecentriq) and the anti-VEGF antibody bevacizumab (Avastin). This treatment was evaluated in patients with unresectable HCC in the IMbrave150 trial and reported an overall survival rate of 67.2% at 12 months.

Pembrolizumab Not Cost-Effective For Second-Line Treatment Of HCC In The US
28 January 2021
According to a recent analysis, pembrolizumab may not be a cost-effective second-line therapy for Hepatocellular Carcinoma (HCC). Dr. Chi-Leung Chiang, Department of Clinical Oncology, University of Hong Kong (China) and colleagues conducted an economic evaluation to assess the cost-effectiveness of pembrolizumab from the US payer perspective, using data from the KEYNOTE-240 trial. The team created a specific model to compare the lifetime cost and efficacy of pembrolizumab, including life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER), which were estimated at a willingness-to-pay threshold of $150,000 per QALY. Pembrolizumab increased the overall cost by $47,057, resulting in an ICER of $340,409 per QALY. To be considered cost-effective, Dr. Chiang and colleagues determined that the price of pembrolizumab would need to be reduced by 57.7% to $2925 per cycle.

FDA Clearance For Hepatica, Perspectum’s Surgical Decision Support Tool For Liver Cancer
28 January 2021
Perspectum has accepted their 501(k), a premarket submission to demonstrate that the device to be marketed is as safe and effective, for Hepatica. Hepatica is a precision oncology decision support tool for liver cancer, which uses non-invasive quantitative MRI to provide a liver health assessment based on AI-driven liver segmentation. A research team has shown that Hepatica could effectively identify if a patient is at risk of poor outcomes from surgery and a longer stay in hospital. “Hepatica provides the surgeon with a measure of liver well-being that allows us to push the boundaries on the one hand whilst avoiding the removal of inappropriate liver volume on the other,” explains Mr. Myrddin Rees, Consultant General and Hepatobiliary Surgeon at HHFT. Perspectum works to deliver cutting-edge digital technologies that help clinicians provide better care for patients with liver disease.

Jellyfish Venom Stops Cancer Cell Growth In Lab Trial
28 January 2021
Researchers from the University of Madras tested crude venom from the Acromitus flagellatus jellyfish against different human cancer cell lines in vitro, and have identified it as a potential cancer therapy. The team's initial results showed that cells from the human liver cancer cell line HepG2 shrank significantly within 48 hours of exposure to the venom. Animal venoms work by targeting and disrupting metabolic processes, and the bioactive compounds in venom attack on a cellular level, destroying cell structures. The ability to target and kill cells or to override biological signals are key elements in modern pharmaceuticals. The team was interested in researching the venom’s cytotoxicity, or its ability to prevent cells from growing and multiplying.

FDA Grants Orphan Drug Designation To Uttroside-B For Liver Cancer
27 January 2021
The FDA has granted Orphan Drug Designation to Uttroside-B for the treatment of Hepatocellular Carcinoma (HCC). Uttroside-B is a small molecule chemotherapeutic created by Q Biomed Inc. “Orphan Drug Designation gives our Uttroside-B program a substantial boost, and we expect it will significantly accelerate development and reduce costs. We are pleased that the FDA recognizes the urgent need for effective treatments for HCC and that the agency sees the potential of Uttroside-B to address this difficult-to-treat cancer,” said Q BioMed CEO Denis Corin in the press release.

Evidence Grows For Avoiding Biopsy In Hepatocellular Carcinoma
27 January 2021
Based on an analysis of the data from the National Cancer Database (NCD), overall survival was lower in HCC patients who underwent preoperative tissue diagnosis compared with clinical diagnosis. Furthermore, researchers insist that doctors should run through all non-invasive methods to diagnose HCC before attempting a biopsy. “Tumor dissemination along the needle tract is a well-documented phenomenon, estimated to occur in 2.5% to 10% of cases,” said Fadi Dahdaleh, MD, a cancer surgeon and clinical assistant professor of surgery at Edward-Elmhurst Health, in Chicago. Using the NCD the team of researchers identified 16,366 patients who matched their criteria. 70.4% of cases had a clinical diagnosis and 29.6% underwent tissue diagnosis, and the team found that patients who underwent tissue diagnosis had decreased overall survival compared with the clinical diagnosis group.

Post-Treatment Alpha-Fetoprotein Reduction Prognostic For Survival Outcomes In HCC
26 January 2021
Ghassan Abou-Alfa, MD from the Memorial Sloan Kettering Cancer Center in New York, discusses results from a study evaluating the association between post-treatment α-fetoprotein reduction and real-world outcomes in US patients with Hepatocellular Carcinoma (HCC). He explains that “In the CELESTIAL study of cabozantinib versus placebo if you recall, the 20% cutoff was brought in. Patients with more than or equal to 20% decrease from baseline α-fetoprotein were associated with longer survival and progression-free survival, regardless of the treatment. However, the association between α-fetoprotein reduction after initiation of first-line therapy with tyrosine kinase inhibitor and outcomes is remaining unclear with advanced Hepatocellular Carcinoma patients.”

Hepatocellular Carcinoma: Support For The Fourth Leading Cancer-Related Cause Of Death
20 January 2021
Hepatocellular Carcinoma (HCC) is a preventable type of cancer, but once HCC is established and symptomatic, survival rates diminish drastically. The four main HCC risk factors are Hepatitis B, Hepatitis C, excessive alcohol consumption, and Nonalcoholic fatty liver disease (NAFLD) leading to nonalcoholic steatohepatitis (NASH). Discussing staging with patients can be difficult, and the literature is often aimed at clinicians Blue Faery: The Adrienne Wilson Liver Cancer Association provides clinically accurate and completely understandable materials to assist doctors and patients in describing the staging and helping patients to understand where they are in the spectrum. The Blue Faery and Exelixis staging discussion pad contain anatomical graphics and easy to understood text. Available to patients is also The Blue Faery Liver Cancer Community. It is a free, HIPAA-compliant online community where patients and caregivers are welcome to join and to seek or exchange information relevant to HCC care.

Patients With Advanced HCC Often Do Not Receive Second-Line Therapy In Real-World Practice
19 January 2021
Arjun Gupta, MD, from Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, discusses results from a study analyzing real-world treatment patterns and associated outcomes for the second-line treatment of advanced Hepatocellular Carcinoma (HCC). His team of researchers used the Concerto HealthAI database and included patients diagnosed with advanced liver cancer between 2017 and January of 2020, which was about 600 patients, and only 330 of these received some sort of therapy. The most commonly used first-line treatment was sorafenib. Of these 330 patients, 207 patients survived 1 month after the end of their first-line therapy and were labeled as being eligible for second-line therapy. Of these 207 patients, only approximately 100 eventually ended up receiving second-line therapy.

Pembrolizumab Monotherapy May Play Role In Treatment-Naive HCC
18 January 2021
Results from a recent study show that Pembrolizumab (Keytruda) monotherapy showed antitumor activity survival in patients with previously untreated Hepatocellular Carcinoma (HCC). In the study, 51 patients were enrolled and treated with Keytruda, and 22 of which demonstrated at least some reduction in the size of their target lesion. The overall response rate (ORR) was 16%, with 70% of patients estimated as having a response duration of 12 months or more. The team reported the progression-free survival (PFS) rate at 12 months was 24%, and the median overall survival (OS) was 17 months. “These findings support further evaluation of pembrolizumab-based regimens in the therapeutic landscape of HCC,” Jean-Luc Van Laethem, MD, Ph.D., of Hôpital Erasme–Université Libre de Bruxelles (ULB), Brussels, Belgium.

Hepatocellular Carcinoma Treatment Landscape Evolving By The Minute
17 January 2021
Ghassan K. Abou-Alfa, MD, a medical oncologist at the Memorial Sloan Kettering Cancer Center in New York, discusses the rapid evolution observed in the treatment landscape of Hepatocellular Carcinoma (HCC) over the last few years. According to Abou-Alfa, the treatment landscape did not begin rapidly evolving until more recently, after about 20 years of minimal advances. He focuses on the treatment combination of pembrolizumab (Keytruda), an immune checkpoint inhibitor (ICI), and lenvatinib (Lenvima) a tyrosine kinase inhibitor (TKI). He points out that the FDA had approved the combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin), in May 2020 for unresectable or metastatic HCC.

Second-Line Pembrolizumab Shows Continued OS And PFS Improvement In Advanced HCC
17 January 2021
Positive updated data from phase 3 KEYNOTE-240 has been reported. The phase 3 trial enrolled adult patients with confirmed diagnoses of advanced HCC who experienced progression after or were intolerance to sorafenib (Nexavar). The median progression-free survival (PFS) was 3.3 months with pembrolizumab, compared with 2.8 months with a placebo, and the estimated 24-month PFS rates were 11.8% and 4.8%, respectively while the estimated 36-month PFS rates were 9% and 0%, respectively. According to a presentation given at the 2021 Gastrointestinal Cancers Symposium, at a median follow-up of 39.6 months for pembrolizumab and 39.8 months for placebo, the median overall survival (OS) was 13.9 months with pembrolizumab versus 10.6 months with a placebo.

Japanese Team Develops Cancer Detector Using Mosquito's Sense Of Smell
15 January 2021
A Japanese research team led by University of Tokyo Professor Shoji Takeuchi has developed a small sensor to detect an odor substance found in the breath of cancer sufferers using mosquito olfactory receptors. When an odorant receptor connects with a specific odorant molecule, a hole opens up on the cellular membrane to let ions enter the cell, allowing the smell to be detected. Takeuchi team created an artificial cellular membrane embedded with a mosquito odorant receptor that detects octenol, a chemical that is found in human perspiration and can be used as a biomarker of liver cancer. A lunch box-sized prototype detected octenol at a concentration of 0.5 part per billion in breath samples within 10 minutes, according to the team's study.

Lenvatinib Monotherapy Demonstrates Efficacy In The First Line For HCC
15 January 2021
Lenvatinib was approved as monotherapy in patients with HCC in August 2018 based on the phase 3 REFLECT trial. A team of researchers conducted a retrospective, real-world analysis of patients with unresectable HCC in the United States to observe that lenvatinib (Lenvima) alone was effective as a first-line treatment. The average dose of lenvatinib was 12 mg. The median progression-free survival (PFS) and overall survival (OS) with lenvatinib had not been reached in any of the sub-categories at the 9-month follow-up. The landmark PFS was 85% at 6 months and 65% at 12 months in the overall cohort. The provider-reported best response was complete response (CR) in 21% of patients in the overall cohort, partial response (PR) in 44%, and stable disease (SD) in 26%.

Validated Risk Score Predicts Post-Transplant Survival In HCC
15 January 2021
Using the national registry data, David Goldberg, MD, MSCE, from the division of digestive health and liver diseases at the University of Miami Miller School of Medicine, and a team of researchers performed a retrospective cohort study of 6,502 adult HCC liver transplant recipients. They developed a risk score to predict post-transplant survival for patients with Hepatocellular Carcinoma (HCC) which will help prioritize patients who are waitlisted for a transplant, based on predicted survival. Absolute predicted survival time from the Liver Transplant Expected Survival HCC score was calculated and compared with available risk scores.

Scoring System To Redefine How U.S. Patients Prioritized For Liver Transplant
13 January 2021
A team of researchers, along with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine are collaborating with faculty at the University of Pennsylvania to develop a risk score that more comprehensively prioritizes liver cancer patients for transplantation. Currently, liver transplant priority in the U.S. goes to the sickest patients and does not consider other important factors, including how long patients are likely to survive post-transplant. The team's paper documenting the development and validation of the LiTES-HCC score to predict post-transplant survival for Hepatocellular Carcinoma, or liver cancer, patients were published in the Journal of Hepatology. Dr. Goldberg, the principal investigator for an ongoing National Institutes of Health grant, states: “There are two large subsets of patients awaiting liver transplantation: those who have cirrhosis and complications from that, and then about 20% to 25% of transplants are for people who have liver cancer, which is a known complication of cirrhosis.”

Zhongchao Inc. Promotes Standardized Liver Cancer Diagnosis And Treatment
13 January 2021
Zhongchao Inc. co-sponsored the National Annual Conference for Standardized Liver Cancer Diagnosis and Treatment with the China Association of Health Promotion and Education and the Chinese Society of Liver Cancer. Jia Fan, Chinese Academy of Sciences Fellow, President of Zhongshan Hospital at Fudan University, and General Supervisor of the Guidelines, stated in the Annual Conference, “prolonging patients' life is the most pressing issue in the field of liver cancer treatment in China. We draft and continuously update the Guidelines based on research developments and lead doctors' clinical practice.” In 2020, Zhongchao worked with medical associations and experts to accomplish a multi-year online education project on the diagnosis and treatment of primary liver cancer.

Frontline Treatment Arsenal Expands In Advanced HCC
11 January 2021
Currently, there are three FDA-approved front-line treatment options for patients with unresectable HCC. These treatments are the tyrosine kinase inhibitor (TKI) sorafenib (Nexavar), approved in 2008; TKI lenvatinib (Lenvima), approved in 2018; and immunotherapy with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin), approved in 2020. A team of doctors further discusses how to choose between the treatments for their current patients. Although sorafenib was the first drug to show a survival benefit in patients with advanced HCC, Tanios S. Bekaii-Saab, MD, explains that “the dose was challenging, and everyone came up with their dosing schedule and regimen [to reduce the risk of toxicities].” However, Pierre Gholam, MD said, “How might one manage or mitigate the risk of bleeding in the setting of cirrhosis? An important thing to remember and consider is that the risk of having varices or, perhaps, more importantly, large varices, increases as the Child-Pugh score increases.”

Liver Stiffness Before Hepatitis C Treatment Predicts Liver Cancer Risk
11 January 2021
Over time, hepatitis C can lead to liver fibrosis, cirrhosis and extracellular carcinoma (HCC). An imaging method known as transient elastography, or FibroScan, measures liver stiffness which can be used as an indicator of fibrosis and the likelihood of developing liver cancer. A liver stiffness measurement taken before beginning direct-acting antiviral (DAA) therapy for hepatitis C may help predict HCC risk in people who have attained a sustained virological response (SVR). One particular study conducted in Denmark, observing over 700 people, found that people with a pre-treatment liver-stiffness measurement (LSM) higher than 17.5 kPa, the incidence of liver cancer rose 10-fold compared with people who had a measurement below this value.

Real-World Findings In REFINE Study Support Use Of Regorafenib In HCC
8 January 2021
Richard S. Finn, MD, an assistant professor of clinical medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA) discusses the real-world findings from the REFINE study and the RESORCE study. The REFINE study observed the outcomes of patients with unresectable Hepatocellular Carcinoma (HCC) who received treatment with regorafenib (Stivarga), while patients in the RESORCE study received sorafenib. In both studies, more than half of the doctors started their patients on the full dose as prescribed, while others started patients at 80 or 120 mg per day. Regardless, the efficacy and side effect profiles were similar between those treated in the real world versus the clinical trial setting, explains Finn. “Patients who were on sorafenib for a shorter period, they still received a similar magnitude of benefit with regorafenib, and vice versa”, Finn says.

Liver Cancer Cells Cause Stromal Cells To Secrete Protein That Enhances Tumor Growth
6 January 2021
In hope of finding a novel target for drug development, researchers led by Osaka University decided to focus on specific cells and processes that occur in the area around liver tumors. They found that cultured liver cancer cells together with HSCs, created a significant increase in the number of cancer cells, suggesting that the HSCs promoted cancer cell growth. Senior author Tetsuo Takehara stated, “Most importantly though when we then examined the association between GDF15 expression and clinical outcome, we found that patients with higher levels of GDF15 had a poorer prognosis than those with only low levels of GDF15 expression, which highlighted the role of GDF15 in HCC progression.” Using a mouse model of liver cancer and analysis of gene expression, the team found that the cancer cells induced autophagy, the digestion of cellular constituents by enzymes of the same cell, in the HSCs, which in turn caused the HSCs to secrete a protein called GDF15, which promoted tumor growth. Using these findings, new therapies targeting GDF15 expression by HSCs are a prospect for the treatment of HCC.

Immunotherapy With Radiotherapy Could Improve Outcomes Of Cancers In Liver
6 January 2021
A team of researchers from the University of Michigan found that tumors in the liver remove critical immune cells, thus making immunotherapy ineffective. Using mice with liver metastases, researchers delivered radiation therapy directly to the tumors in the liver, preventing T-cell death. With the T cells restored, an immune checkpoint inhibitor was then able to activate the immune system to eliminate cancer throughout the body. Thus, treatment with immunotherapy in combination with radiotherapy to the livers of mice restored the immune cell function and led to better outcomes. The team looked at data from 718 patients who had received immunotherapy. Those with liver metastases had worse responses to immunotherapy. Dr. Michael Green noted that patients with liver metastases who received chemotherapy or targeted therapies did not have worse outcomes compared to those with other types of metastases.

Comparable Survival Observed With Regorafenib In HCC In Real-World Versus Clinical Settings
5 January 2021
The addition of regorafenib to the armamentarium as a treatment for patients with Hepatocellular Carcinoma (HCC), has brought about an exciting advance for the field over the last few years. According to findings from the phase 3 RESORCE study, regorafenib (Stivarga) demonstrated encouraging findings in HCC patients. “The RESORCE study was the first positive phase 3 study in liver cancer since sorafenib in 2007,” stated Richard S. Finn, MD, an assistant professor of clinical medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA). The ongoing REFINE study is aimed to explore the safety, tolerability, and efficacy of regorafenib in the real world compared with patients who received regorafenib in the clinical trial setting using data from patients in the RESORCE study.

Immunicum AB Receives FDA Orphan Drug Designation For Ilixadencel As A Treatment HCC
31 December 2020
The FDA has granted Orphan Drug Designation to ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Hepatocellular Carcinoma (HCC). The designation was based on data from a Phase I/II clinical trial of ilixadencel in patients with unresectable and/or metastatic HCC. Ilixadencel is a cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells which are derived from healthy blood donors. Injection of these cells in the patient’s tumor generates an inflammatory response which in turns leads to tumor-specific activation of the patient’s cytotoxic T cells. In various trials, including the Phase II MERECA trial, Ilixadencel has maintained a positive safety and tolerability profile and demonstrated signs of efficacy.

For past liver cancer news, please visit our Liver Cancer News Archives.

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