Liver Cancer News 2020
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New Drugs Approved For Liver Cancer Treatment
20 March 2020
Bristol Myers Squibb has received approval from the FDA for its immunotherapy medications, Yervoy and Opdivo for the treatment of patients with Hepatocellular Carcinoma(HCC) who have been treated by sorafenib previously. Based on previous clinical trial results, 33% of participants had responded to the treatment. Nivolumab, another treatment approved for HCC may come with serious side effects, including colitis, renal dysfunction, and inflammation of the lungs. HCC is the most common type of liver cancer and has been on the rise in the US.
Dicerna Receives Orphan Drug Designation From U.S. Food And Drug Administration For DCR-A1AT For Treatment Of Alpha-1 Antitrypsin Deficiency
18 March 2020
Dicerna Pharmaceuticals has been granted orphan drug designation by the FDA for DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency. A1AT deficiency is a genetic disorder that can cause liver disease. Dicerna is a biopharmaceutical specializing in investigational ribonucleic acid interference (RNAi) therapeutics. A1AT is a protein produced in and released from the liver. “RNAi technology has shown significant potential in the treatment of liver-related diseases, and we look forward to continuing to investigate DCR-A1AT’s potential to make a meaningful difference for this underserved patient population,” said Ralf Rosskamp, M.D., chief medical officer of Dicerna. Dicerna has submitted a clinical trial application to the Swedish Medical Products Agency for DCR-A1AT for the treatment of patients with A1AT deficiency-associated liver disease and began has already begun enrolling healthy volunteers in the Phase 1/2 trial of DCR-A1AT.
Liver Cancer Symptoms: An Uncomfortable Sign On The Skin Could Signal The Disease
17 March 2020
Liver cancer develops when abnormal cells start to divide and grow in an uncontrolled way in the liver, and the earlier it is detected, the better the chance of survival is. Unfortunately, cancer is often detected in advanced states. Cancer has several external symptoms. Some warning signs are frequent hiccups, itchy skin, and jaundice. Other serious indications may be loss of appetite, feeling very full after eating any size meal, and pain or swelling in the abdomen. A color change in stool may also indicate something is wrong.
Can-Fite: Progress In Compassionate Use Program Treating Advanced Liver Cancer Patients With Namodenoson
16 March 2020
Can-Fite Biopharma Ltd has already enrolled 7 patients for the compassionate use program for Namodenoson in the treatment of hepatocellular cancer (HCC) led by Dr. Salomon Stemmer, Professor at the Institute of Oncology, Rabin Medical Center, Israel. Namodenoson is a small oral drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Can-Fite has also submitted a Phase III protocol and Registration Plan to the European Medicines Agency (EMA) for Namodenoson. The completed Phase II trial as a second-line treatment found Namodenoson to have a good safety profile and was well tolerated.
HCC Treatment Continues To Improve, But Biomarkers Are Still Needed
14 March 2020
The past few years have seen a large increase in targeted therapies and immunotherapy options to treat Hepatocellular Carcinoma (HCC). Doctors now will need to focus on the proper sequencing of these treatments which will be most effective for their patients. Earlier this year a supplemental biologics license application (sBLA) was submitted to the FDA for the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) as a treatment, based on the results of the phase III IMbrave150 trial in which the median overall survival (OS) was not reached with the combination as compared with 13.2 months with sorafenib. In 2019 regorafenib and cabozantinib (Cabometyx) were approved for treatment as well.
FDA Approves Nivolumab Plus Ipilimumab In Advanced Hepatocellular Carcinoma
11 March 2020
Recently the FDA granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of patients with Hepatocellular Carcinoma (HCC) who were previously treated with sorafenib (Nexavar). The overall survival (OS) of patients using nivolumab and ipilimumab as a second-line treatment of HCC showed promising results based on the CheckMate-040 clinical trial which included a total of 148 patients. Results from that trial showed that of the 33% of patients who responded to treatment with the combination, 8% had a complete response and 24% had a partial response, at the 28 months. Additionally, patients who received 6 months of sorafenib or more experienced an overall response rate of 36.4%
Aspirin May Reduce Risk For Hepatocellular Carcinoma, Liver-Related Mortality In Chronic Viral Hepatitis
11 March 2020
According to the results of a retrospective study, low-dose aspirin use was associated with significantly lower risk for Hepatocellular Carcinoma (HCC) among patients with chronic viral hepatitis. Experimental and clinical data show that aspirin may prevent liver disease progression and hepatocarcinogenesis, the production of cancer in the liver. It works by preventing platelet break-down, modulating bioactive lipids and inhibiting inflammation. The retrospective study analyzed over 14.000 Swedish patients diagnosed with Hepatitis B or C and no history of aspirin use. Results showed an estimated 10-year cumulative incidence of HCC of 4% among aspirin users and 8.3% among nonusers. Further analysis showed aspirin users had a 31% lower risk for HCC than nonusers.
Optimizing Treatment Approaches For Hepatocellular Carcinoma
10 March 2020
“Patients with HCC often shift from locoregional or radical care to palliative care, which makes it crucial that physicians have an ongoing multidisciplinary effort when managing these patients,” says David J. Pinato, MD, PhD of the Department of Surgery and Cancer, Imperial College London. According to Pinato, it is important for doctors to use a multidisciplinary approach when treating patients with HCC. AS more treatments are approved, researchers will look for a link between good management of underlying liver function with good oncologic management.
Chinese Biotech Startup Genfleet Closes $58m In Series B Round
8 March 2020
GenFleet Therapeutics, a Shanghai-based pharmaceutical company, is currently developing GFH018, a small molecule inhibitor for the treatment of Hepatocellular Carcinoma (HCC). The Phase 1 trial has already begun in Shanghai. The clinical trial application of GFH018 has been approved by China’s Center for Drug Evaluation (CDE), said Lu Qiang, chairman and founder of GenFleet. GenFleet was able to raise $17 million in a Series A round led by Ally Bridge Group, a healthcare-focused investment company founded by former Goldman Sachs executive Frank Yu. Proceeds of the Series B round will be used to finance overseas registration and clinical trials.
Liquid Biopsy May Play A Role In Identifying Markers Of Response In HCC
6 March 2020
According to Augusto Villanueva, MD, assistant professor of the Division of Liver Diseases at the Tisch Cancer Institute of Icahn School of Medicine at Mount Sinai Hospital, Hepatocellular Carcinoma (HCC) lacks in identifying markers of response and genetic drivers. Liquid biopsies can help in finding biomarkers. Also, analyzing plasma can help physicians detect driver genes more effectively and efficiently. Researchers use the circulating tumor cells to help provide more information on potential biomarkers. Villanueva states, “In the last 10 years, we have gained a significant understanding of the driver mutations in HCC. The most prevalent mutations are TERT promoter, TP53, β-catenin.”
Roche Gets U.S. Breakthrough Tag For Liver Cancer Diagnosis Approach
3 March 2020
Roche Diagnostics has developed the Elecsys GALAD score, which combines factors including age, gender and biomarker results to more quickly and accurately diagnose early-stage Hepatocellular Carcinoma (HCC. This diagnostic approach has been given Breakthrough Device Designation by the FDA. Roche is also working on a combination treatment using Tecentriq and Avastin, which has been submitted for FDA approval. “The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a timelier diagnosis and treatment,” said Roche Diagnostics head Thomas Schinecker.
Doctors Testing New Liver Transplant Transport System
2 March 2020
Intermountain Healthcare officials are currently testing a new liver transport system called the hypothermic machine perfusion pump, which could save patients on the transplant list by better preserving the organs in transit. The standard way of transporting a liver involves placing the liver in a bag of special fluid and packing it in ice in a cooler. The new pump is considered an “active” transportation, as the case that the liver is in has what a liver needs to keep working. The pump circulated perfusion solution through the liver to eliminate stagnant blood. Jake Krong is the research manager at Intermountain Transplant Services. Intermountain Healthcare is participating in clinical trials with five other transplant centers.
Biomarkers, Patient Factors Inform HCC Treatment Decisions Beyond Frontline Setting
2 March 2020
Lipika Goyal, MD, an instructor at Harvard University Medical School, stated, “There are clear biomarkers available to guide treatment decisions in the second-line setting for patients with advanced Hepatocellular Carcinoma (HCC). Goyal refers to the phase III IMbrave150 trial including atezolizumab (Tecentriq) and bevacizumab (Avastin) the “-1 line of therapy” because the combination has not been FDA approved. She also believes that for patients who have already received the combination of atezolizumab/bevacizumab, Yttrium-90 (Y-90) embolization may be a viable option, before proceeding to sorafenib (Nexavar) or lenvatinib (Lenvima). Based on the data from the phase III RESORCE trial, it was the first to demonstrate a survival benefit for a systemic therapy in the second-line setting for patients with advanced HCC who progressed on sorafenib.
El-Khoueiry Forecasts Future Of HCC Treatment Paradigm
2 March 2020
Anthony El-Khoueiry, MD, assistant professor of clinical medicine at the Keck School of Medicine at the University of Southern California, believes that by 2025 there will be many more approved drugs and drug combinations for the treatment of advanced Hepatocellular Carcinoma (HCC). Currently, there are only 2 first-line treatments, which are used, sorafenib (Nexavar) and lenvatinib (Lenvima). A front-line combination therapy is atezolizumab (Tecentriq) plus bevacizumab (Avastin). Second-line therapies include regorafenib (Stivarga), nivolumab (Opdivo), and pembrolizumab (Keytruda). El-Khoueiry stresses that the drug development companies should address molecular heterogeneity more closely.
Recent Approvals, Collaborative Care Model Spark Change In HCC Treatment
2 March 2020
Michael R. Charlton, MD believed that the study of Hepatocellular Carcinoma (HCC) is moving toward a more comprehensive, personalized, and optimistic approach in treatment due to the new therapies and potential biomarker discoveries. In addition, the care team of the patient now includes an oncologist, a radiologist, and a surgeon so that their collaboration can offer the best treatment options. Charlton hopes to see more patients screened early, in the future, so that if they are diagnosed, they may be treated with resection or locoregional therapy.
Medivir Presents Positive Data From The Completed Phase IA Study With MIV-818 In Patients With Advanced Liver Cancer
2 March 2020
Medivir AB recently conducted a phase IA study with MIV-818 , an orally administered drug, to evaluate safety and tolerability in liver cancer patients. Two of the nine patients involved in the study had Hepatocellular Carcinoma (HCC). Biomarker analysis of liver biopsies showed a selective liver cancer effect of MIV-818, where the tumor tissue had clear DNA damage while healthy liver tissue showed only minimal or no DNA damage. The analysis of data from the nine patients confirms the researchers' conclusion that the continued development of MIV-818 as a new and effective treatment for liver cancer would be beneficial.
Immunotherapy Combinations Show Promise in Advanced HCC
1 March 2020
El-Khoueiry, associate professor of medicine at USC Norris Comprehensive Cancer Center, explains that there are several reasons why monotherapy trials have failed, including the idea that a single agent therapy might not be enough to treat Hepatocellular Carcinoma (HCC). El-Khoueiry expresses the importance for anti-VEGF agents and tyrosine kinase inhibitors (TKIs) to work together, based on previous research which shows that targeting the VEGF axis leads to decreases in the activity of inhibitory cells, increased PD-L1 expression, and enhanced T cell tumor infiltration and activation. The combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) demonstrated strong efficacy as first-line therapy in patients with unresectable HCC.
Evidence Illustrates Multidisciplinary Care Is Standard In HCC
1 March 2020
Amit G. Singal, MD, medical director of the Liver Tumor Program at The University of Texas Southwestern (UTSW) Medical Center, encourages treatment for patients with Hepatocellular Carcinoma (HCC) which incorporates multiple providers from a variety disciplines as it may lead to better results. Based on previous research, underuse or the delays of optimal HCC treatment are associated with worse survival outcomes. A retrospective cohort study including 267 treatment-eligible patients showed a median time to treatment as 1.7 months. Singal stressed that optimal timing of appropriate therapy is key in HCC management.
Biomarker Hunt Gains Traction Among Therapeutic Advances In HCC
29 February 2020
David J. Pinato, MD, Ph.D., states “This is a moment of dramatic change in HCC care. [The lack of biomarkers] was [a result of] a vicious circle. Patients were not routinely biopsied because there were no alternative therapies to offer them. That led to a lack of updated knowledge of the molecular pathophysiology of liver cancer. Then, that led to a lack of biomarkers for these patients.” the team of researchers continue to search for the optimal markers that could predict response to the growing number of therapies. PD-L1 expression for immunotherapy and FGF19 expression another potential target being explored is are currently being explored.
Dr. Parikh On The Importance Of Multidisciplinary Care In HCC
29 February 2020
According to Neehar Parikh, MD, medical director and assistant professor at the University of Michigan, patients with Hepatocellular Carcinoma (HCC) are commonly treated by a multidisciplinary team in the university setting, including hepatologists, interventional radiologists, oncologists, diagnostic radiologists, and palliative care specialists. The care team works as a single unit to optimize treatment for patients and address any complications that may develop. Studies show that there is a survival advantage when patients who receive curative intent therapy are treated by a multidisciplinary team compared with those treated by a single physician.
Abou-Alfa Hails “Positive And Disruptive” Impact Of Novel Combinations In HCC
28 February 2020
Results of the phase III IMbrave 150 trial showed that the combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin) improved overall survival (OS) versus sorafenib (Nexavar) in patients with Hepatocellular Carcinoma (HCC). At the 8.6-month follow-up, researchers saw a 42% decrease in the risk of death and a 41% decrease in the risk of disease progression or death in the atezolizumab/bevacizumab arm versus sorafenib. The median progression-free survival (PFS) was 6.8 months with combination therapy and 4.3 months with sorafenib alone. Ghassan K. Abou-Alfa, MD., a medical oncologist at Memorial Sloan Kettering Cancer Center, said the combination will overtake sorafenib as the standard of care in the first-line setting at some point.
Pre-Clinical Studies Demonstrate CBD’s Robust Anti-Cancer Effect Against Liver Cancer; Can-Fite And Univo Pharmaceuticals Expand Collaboration Agreement
27 February 2020
Can-Fite BioPharma Ltd. in collaboration with Univo Pharmaceuticals, has published pre-clinical findings showing the inhibiting characteristics which CBD has against liver cancer. The results are based on studies utilizing human liver cancer cells. UNIVO produces its own cannabis through a partnership with Amit Farms, located in Israel. The agreement with Univo Pharmaceuticals includes testing of minute CBD dosages in combination with Namodenoson on liver cancer.
Prevention Signal For Statins In Liver Cancer Supports Prophylaxis
26 February 2020
According to the investigator, statins have shown to provide significant protection against liver cancer and should be considered in patients at high risk. Muhammad T. Sarmini, MD, a gastroenterologist affiliated with the Cleveland Clinic in Cleveland, stated that the analysis of 20 studies with approximately 2.6 million patients worldwide, showed that the use of the cholesterol agents was associated with a 43% reduction in the risk for Hepatocellular Carcinoma (HCC). Upon categorizing the studies, the team found that the risk reduction for statins was 47% for case-control studies and 37% for cohort studies.
Abivax Includes First Patient In U.S. Phase 1/2 Clinical Trial Of ABX196 To Treat Hepatocellular Carcinoma
26 February 2020
Abivax SA is currently conducting a Phase 1/2 clinical trial of ABX196 to treat patients with Hepatocellular Carcinoma (HCC). The study will gather data to determine the safety, efficacy and tolerability of the treatment on its own and in combination. The teams of researchers at two MD Anderson Cancer Centers have shown that ABX196 and the combination of ABX196 and a checkpoint inhibitor, showed a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in mice models. ABX196 is intended to enhance the efficacy of checkpoint inhibitors by activating iNKT cells to kill tumor cells.
ARID2 Suppresses Hepatocellular Carcinoma Metastasis Via DNMT1-Snail Axis
24 February 2020
Dr. XIE Dong of the Shanghai Institute of Nutrition and Health of the Chinese Academy of Sciences recently published the results of his study on the role and mechanism of AT-rich interactive domain 2 (ARID2) in liver cancer metastasis, providing therapeutic targets for the treatment of Hepatocellular Carcinoma (HCC). The team found that ARID2 expression was significantly decreased in metastatic HCC tissues, and showed a negative correlation with organ metastasis and positive association with survival of HCC patients. Based on HCC mouse models, ARID2 knockout promoted pulmonary metastasis, secondary malignant tumors.
Tetra In Manufacturing Deal For Printed CBD Treatment
18 February 2020
Tetra Bio-Pharma has signed an agreement with Vitiprints for the commercial manufacture of two CBD-based drug candidates, Caumz (synthetic tetrahydrocannabinol (THC) and cannabidiol (CBD)) and HCC011 (inhaled delta-9-THC). Caumz is currently at Phase II and HCC011 is being investigated at the same stage for Hepatocellular Carcinoma (HCC). This collaboration will increase production from 2,500 dosing capsules in a three-day period to 100,000 dosage units in a single eight-hour period. Vitiprints specializes in 2D printing technology and will provide Tetra Bio-Pharma with an exclusive license for the commercial production of its two drug candidates, for use within a vaporizing system, Caumz-kit.
Hepatocellular Carcinoma: 5 Things To Know
14 February 2020
Patients who are at risk or have been diagnosed with Hepatocellular Carcinoma (HCC) have any things to consider. It is important to keep in mind that cirrhosis is the biggest risk factor for HCC. One third of all patients with cirrhosis will develop HCC. Check-ups are recommended every six months. Fatty liver is another major factor contributing to the rise in HCC incidence. Patients also need to be aware that treating chronic hepatitis infection reduces the risk for HCC but does not eliminate it. Curing chronic hepatitis C infection is associated with a 71% risk reduction of HCC.
Can-Fite Submits Liver Cancer Phase III Protocol and Registration Plan to EMA for Namodenoson
13 February 2020
Can-Fite BioPharma Ltd. has begun a Phase III trial to evaluate the efficacy of Namodenoson in patients with advanced Hepatocellular Carcinoma (HCC). The FDA approved Can-Fite’s proposed Phase III trial design to support a New Drug Application (NDA) submission and approval of Namodenoson for the treatment of HCC. Namodenoson is a small oral treatment that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Can-Fite is biotechnology company that develops small molecule drugs for the treatment of cancer and liver disease.
Patient-Reported Outcomes Show Newer Drug Combinations Maintain Quality Of Life Longer Than Current Standard-Of-Care Treatments
13 February 2020
Recently many new combination therapies have come to light for the treatment of patients with advanced Hepatocellular Carcinoma (HCC). Combination treatment of atezolizumab (Tecentriq) plus bevacizumab (Avastin) showed better patient-reported outcomes than treatment with sorafenib (Nexavar) in patients with HCC. The triple combination therapy using nivolumab (Opdivo), ipilimumab (Yervoy), and cabozantinib (Cabometyx) provided clinically meaningful responses in patients with advanced HCC who were treatment-naïve or intolerant of sorafenib. Therapy combination nivolumab plus cabozantinib reported a median progression-free survival (PFS) of 5.4 months and median overall survival (OS) of 21.5 months.
VEO Oncology Announces Publication Of Phase 1b/2 Study Of Tivozanib In Advanced, Inoperable Liver Cancer
12 February 2020
AVEO Oncology is developing a new treatment called FOTIVDA (tivozanib), for the treatment of patients with advanced, inoperable Hepatocellular Carcinoma (HCC). A total of 27 patients are enrolled in the Phase 1b/2 trial. Median progression-free survival (PFS) was 24 weeks and overall survival (OS) was 9 months, for patients treated at the recommended Phase 2 dose (RP2D) of 1.0 mg once daily for 21 days. Tivozanib has been shown to reduce regulatory T-cell production in preclinical models. Enrollment has begun in a Phase 1b/2 DEDUCTIVE study of tivozanib in combination with AstraZeneca’s IMFINZI® (durvalumab). Tivozanib is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
STIVARGA (Regorafenib) For Patients With Unresectable Hepatocellular Carcinoma
11 February 2020
Regorafenib is approved for the treatment of patients with Hepatocellular Carcinoma (HCC) who have previously been treated with sorafenib. Based on results from the Phase 3 RESORCE trial, regorafenib was shown to increase overall survival. Regorafenib is a multi-kinase inhibitor that blocks multiple protein kinases involved in tumor angiogenesis, the development of new blood vessels, and oncogenesis, the growth of new tumors. The treatment is taken orally. There are currently further ongoing trials for HCC patients with unresectable tumors.
Dr. Abou-Alfa On Progress Made In Hepatocellular Carcinoma
11 February 2020
Ghassan K. Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, believes that there has been very much progress made in the treatment of patients with Hepatocellular Carcinoma (HCC). Sorafenib (Nexavar) is 1 of 7 treatments to receive regulatory approval in HCC, says Abou-Alfa. Sorafenib and lenvatinib (Lenvima) are first-line options. “In the second-line setting, regorafenib (Stivarga), which is conditional on prior sorafenib exposure, cabozantinib (Cabometyx), and ramucirumab (Cyramza), which requires high alpha-fetoprotein are also approved for use. In addition, nivolumab (Opdivo) and pembrolizumab (Keytruda) are approved for use as monotherapy following prior exposure to sorafenib,” Abou-Alfa explains.
Real-World Study Shows Snapshot Of A Survival Gap With Existing Therapies For Patients With HCC
11 February 2020
According to a recent study, patients with Hepatocellular Carcinoma (HCC) who receive systemic therapy have a poor prognosis in the community practice setting. The team looked at over 2000 patients treated with treatments including transplant, stereotactic body radiation therapy (SBRT), radiofrequency ablation (RFS), transarterial chemoembolization (TACE), and a tyrosine kinase inhibitor (TKI) with median overall survival (OS) of 16.6 months. Treatment with a TKI had the lowest OS benefit at 5.0 months, and transplantation had the highest benefit at 71.5 months. Michael A. Morse, MD, heading the study explained that it may not be practical for community oncologists to follow the treatment standards born from clinical trials because average patients with HCC do not have the same outcomes as patients who undergo treatment in the clinical trial setting.
MRI Contrast Agent Detects Early Stage Liver Cancer
10 February 2020
A team of researchers led by Jenny Yang, a professor at Georgia State University and associate director of the Center for Diagnostics and Therapeutics, has identified a new biomarker for detection of liver metastases. They have developed an agent that can target chemokine receptor 4 (CXCR4) which becomes over-expressed in the liver for people with cancer. Researchers expect the CXCR4 targeted protein-based MRI contrast agent will be able to detect even tiny instances of cancer cells on multi-color scans called precision MRI (pMRI) imaging. The team used gadolinium in the MRI and found that protein design is much more effective in targeting the signs of disease.
Cerium Oxide Nanoparticles May Improve Hepatocellular Carcinoma Prognosis
10 February 2020
A team of researchers from the Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS) and from the Catalan Institute of Nanoscience and Nanotechnology (ICN2) have been working together to create an effective treatment for Hepatocellular Carcinoma (HCC) using cerium oxide nanoparticles. Cerium oxide nanoparticles have antioxidant and anti-inflammatory properties have shown to partially reverse the cellular mechanisms involved in tumor progression and have significantly increased survival in a rat animal model. The animal models showed that rats treated with the nanoparticles had fewer cancer nodules in the liver, had reduced levels of the cancer biomarker alpha-fetoprotein, showed less proliferation of the cancer cells and more apoptosis cell death. The study also showed that treated rats have double the survival time of the untreated rats.
Sirnaomics' Sirna Therapeutic Candidate, STP705, Granted Orphan Drug Designation By US FDA For Treatment Of Hepatocellular Carcinoma
10 February 2020
The FDA has granted orphan drug designation to STP705 (Cotsiranib) for the treatment of Hepatocellular Carcinoma (HCC). STP705, created by Sirnaomics, Inc., is a siRNA (small interfering RNA) therapeutic that targets the polypeptide nanoparticle (PNP) to enhanced delivery and destroy the TGF-β1 and COX-2 gene expression. In preclinical animal trials, STP705 has shown a considerable improvement in T-cell penetration into tumors in the liver, and improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. “This orphan drug designation aligns with our mission to alleviate human suffering and target diseases with high unmet clinical need and we anticipate the start of our clinical study for HCC in the second half of 2020,” said Dr. Michael Molyneaux, MD, MBA, Chief Medical Officer.
Geneos To Test GNOS-PV02 Cancer Vaccine In Triple Combo Trial For Advanced Liver Cancer
10 February 2020
GT-30 trial (NCT04251117), a Phase 1/2 trial of a triple immunotherapy combination for the treatment of patients with advanced Hepatocellular Carcinoma (HCC) is being initiated by Geneos Therapeutics. The trial involves their patient-specific cancer vaccine GNOS-PV02. The trial will include 12 HCC patients to test the combination of GNOS-PV02, the immune system modulator INO-9012, and the immune checkpoint inhibitor Keytruda (pembrolizumab). GNOS-PV02 is a personalized cancer vaccine that elicits strong immune responses. INO-9012 is designed to reinforce the activation and expansion of immune T-cells. Keytruda, which is developed by Merck, is an immune checkpoint inhibitor that prevents cancer cells from evading the immune system.
Cancer Breakthrough Raises Hopes Of Early Diagnosis For Liver Cancer
7 February 2020
A team of researchers including Professor Jenny Yang, of Georgia State University and Dr. Alexis Webb, of Cancer Research UK, have proven through experiments with mouse models, that liver cancer can be detected at stage two rather than stage four. Stage two liver cancer is defined as a tumor that is more than 2cm in size and has grown into the blood vessels of the liver. Current testing with biopsy is often done too late, and the cancer is too far along for curative treatment. The team's new method involves injecting a chemical that targets cancer cells and uses a metal element within it. The targeted cancer cells can then which can be seen on an MRI scan. The FDA is currently fast-tracking this new method for clinical trials in humans.
Hi-Precision Diagnostics Launches New Test Panel For Better Liver Cancer Detection
7 February 2020
Hepatitis B affects an estimated 10 percent of Filipinos and is the most common cause of Hepatocellular Carcinoma (HCC) or primary cancer of the liver in the Philippines. HCC is the second most common cause of cancer death in the Philippines as most patients are diagnosed too late for curative treatment. Hi-Precision Diagnostics, a medical laboratory, launched the HCC Risk Panel at the 2020 Philippine Liver Meeting, specifically directed to the delegates of the Hepatology Society of the Philippines as a new tool for early liver cancer detection. The panel is performed by testing blood samples to measure all three markers with the µTASWako i30 platform. Dr. Hiroyuki Yamada, Ph.D., Fujifilm Wako Pure Chemicals representative, discussed how more comprehensive tumor marker screening including AFP, AFP L3, and DCP has improved liver cancer detection and survival in Japan.
Combination Atezolizumab Plus Bevacizumab Improved Quality Of Life In HCC
4 February 2020
The phase III IMbrave 150 clinical trial evaluated the combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin) versus the standard of care, sorafenib (Nexavar), as the frontline treatment Hepatocellular Carcinoma (HCC). Peter R. Galle, MD, the director of the Medical Department at the University Medical Center Mainz explains, “These findings showed that a lower proportion of patients with unresectable HCC had deterioration of quality of life (QoL) with the combination atezolizumab plus bevacizumab compared with sorafenib.” The combination showed time to deterioration of QoL was 11.2 months in the combination arm versus 3.6 with sorafenib, and an extended median time to several symptoms.
Immunitor Publishes Interim Results From Phase III Trial Of Oral Immunotherapy For Liver Cancer
1 February 2020
Mongolia has the highest incidence of Hepatocellular Carcinoma (HCC). As HCC is on the rise the FDA has recently approved three antibody-based drugs for HCC indication: nivolumab, pembrolizumab, and ramucirumab. Previous experiments show that none of the currently approved or experimental HCC drugs are free from adverse side effects, and unfortunately have limited effect in shrinking tumors. Developed by Vancouver-based Immunitor Inc in collaboration with the medical team at the National Cancer Center in Mongolia and investigators in the USA, China and Thailand the therapeutic vaccine called hepcortespenlisimut-L (V5 or Hepko-V5) was successful in a 75-patient Phase II trial in 2017. The anti-HCC property of V5 was discovered accidentally ten years and has been used by over 30,000 individuals since 2002 and has never been reported of causing any serious adverse reactions.
The Role Of The Innate Immune System In The Development And Treatment Of Hepatocellular Carcinoma
31 January 2020
Scientists are currently studying the role of the innate immune system in the development and treatment of Hepatocellular Carcinoma (HCC). The innate immune system is responsible for immune cells infiltrating solid tumors or the tumor microenvironment. The functionality of innate cells is regulated by several factors, including pro- and anti-inflammatory cytokines as well as fibroblasts. Patients with advanced cancer stages who are not eligible for surgical treatment are recommended palliative drug therapies including tyrosin kinase inhibitors (TKI) such as sorafenib, lenvatinib, regorafenib or cabozantinib. Unfortunately, these treatments only offer minimal survival benefits and are regarded as not cost-effective strategies for HCC treatment.
The Impact Of Liver Pathobiology On HCC Treatment Approach
31 January 2020
Ghassan K. Abou-Alfa, MD explains the importance of recognizing that there are specific targets that should be attacked regarding liver cancer. Most of those usually are taken care of by tyrosine kinase inhibition. The role of immunotherapy or checkpoint inhibitors in liver cancer is also very important. A checkpoint inhibitor like an anti–PD-1 [anti–programmed cell death protein 1], like nivolumab or pembrolizumab, has not yet been proven to be more beneficial than a tyrosine kinase inhibitor for patients with liver cancer. The combination of checkpoint inhibitors plus a tyrosine kinase inhibitor is another category of treatment options.
Lenvatinib Appears Effective In Real-Life Retrospective Analysis Of Advanced HCC
31 January 2020
In a retrospective multicenter observational analysis in Korea, the tyrosine kinase inhibitor lenvatinib (Lenvima) demonstrated promising activity and safety in patients with advanced Hepatocellular Carcinoma (HCC). The overall response rate (ORR) was 10.7%. for a total of 75 patients according to RECIST. At a median follow-up of 4.7 months, the median overall survival (OS) was 6.7 months. Stable disease (SD) was observed in 50 patients overall. A complete response (CR) was not observed in any patients, but 8 patients in the overall population had a partial response (PR).
Dr. Villanueva On Eliminating Tumor Heterogeneity In Patients With HCC
27 January 2020
Augusto Villanueva, MD, an assistant professor of the Division of Liver Diseases at the Tisch Cancer Institute of Icahn School of Medicine at Mount Sinai Hospital presented mutations and gene signatures for patients with Hepatocellular Carcinoma (HCC) at the 2020 Gastrointestinal Cancers Symposium. Villanueva's showed a significant connection to the composition of the tumor microenvironment and the heterogeneity at the level of gene expression. He hopes that liquid biopsies may play a role in obtaining new biomarkers for HCC. Previous research shows that analyzing plasma can make it easier to detect driver genes in patients with HCC. DNA, RNA, and microRNA can be analyzed to provide biomarkers for HCC.
Roche Files Tecentriq/Avastin Combo In Liver Cancer
27 January 2020
Based on the results from the IMbrave150 study for Hepatocellular Carcinoma (HCC) Roche has filed Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a first-line treatment. The IMbrave150 study involved patients who could not be treated with surgery and who had not been treated with any other systemic therapy. Patients received PD-L1 inhibitor Tecentriq plus anti-VEGF antibody Avastin or Bayer’s Nexavar (sorafenib) – a standard first-line therapy. According to Roche’s chief medical officer Levi Garraway, if Roche wins approval, the Tecentriq/Avastin regimen would be the first therapy to extend survival in first-line HCC treatment for more than a decade.
Exelixis Announces Results For Combination Of Cabozantinib And Nivolumab With Or Without Ipilimumab In Advanced Hepatocellular Carcinoma
25 January 2020
Exelixis, Inc. has been conducting CheckMate 040, a phase ½ clinical trial testing the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced Hepatocellular Carcinoma (HCC). For the 36 patients treated with the combination of cabozantinib and nivolumab showed a 75% disease control rate (DCR), median progression-free survival (PFS) of 5.4 months, and median overall survival (OS) of 21.5 months. For the 35 patients treated with the combination of cabozantinib, nivolumab and ipilimumab DCR was 83%, the median PFS was 6.8 months, and median overall survival has not yet been reached. Adverse side effects were observed in 47% of the cabozantinib and nivolumab group, and 71% of the cabozantinib, nivolumab and ipilimumab group. These side effects included diarrhea, hypertension, and lipase increase.
Patients With HCC Experience Better OS With Anticancer Procedure After Lenvatinib
25 January 2020
Based on the results of the REFLECT trial, patients with unresectable Hepatocellular Carcinoma (HCC) experienced prolonged overall survival (OS) with lenvatinib (Lenvima) followed by an anticancer procedure, as opposed to sorafenib (Nexavar). Patients treated with lenvatinib demonstrated a median OS of 23.0 months compared with 9.6 months with sorafenib. Those who received subsequent anticancer procedures and/or medications had longer OS compared with those who did not. In the lenvatinib group, median OS was 19.5 months in those who received subsequent anticancer procedures and/or medications compared with 17.0 months in the sorafenib-treated patients who received subsequent anticancer therapy.
Lenvatinib Yields Promising Results In Unresectable HCC
24 January 2020
Based on a retrospective analysis of a phase III clinical trial and the tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima), both showed similar efficacy in patients with Hepatocellular Carcinoma (HCC). The study included 116 patients. 28 patients received lenvatinib as a second-line treatment, and 17 patients received the drug in the third line after second-line regorafenib. 49 patients were evaluated at weeks 4 to 8and found that 3 patients experienced a complete response, 14 patients had a partial response, 23 patients had stable disease, and 6 patients had progressive disease.
Atezolizumab In Combination With Bevacizumab May Be Effective For Patients With HCC
22 January 2020
Results from the IMbrave 150 clinical trial testing the safety and efficacy of atezolizumab (Tecentriq) plus bevacizumab (Avastin) reported high-quality patient outcomes for patients with unresectable Hepatocellular Carcinoma (HCC). The lead author is Peter R. Galle, MD, PhD, from the University Medical Center in Mainz, Germany. The primary endpoint for the study was overall survival, in which patients were randomized 2:1 to receive either atezolizumab plus bevacizumab or sorafenib (Nexavar) alone as a first-line treatment. The median overall survival had not been reached for atezolizumab plus bevacizumab compared with the overall survival of 13.2 months in patients receiving sorafenib alone. The overall response rate was 27% with atezolizumab plus bevacizumab and 12% for the patients receiving sorafenib.
AstraZeneca’s Combination Treatment For HCC Snags Orphan Drug Designation
20 January 2020
The U.S. Food and Drug Administration has granted Orphan Drug designation to AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, for the treatment of Hepatocellular Carcinoma (HCC). The combination of Imfinzi and tremelimumab is being studied as a treatment for HCC in the Phase III HIMALAYA trial. The trial is also assessing Imfinzi as a stand-alone treatment for HCC with results of each being compared to previous treatment results of Nexavar (sorafenib). Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer.
Minimally Invasive Liver Cancer Treatment Improving Quality Of Life For Patients
16 January 2020
Y90 is a minimally invasive procedure used for the treatment for liver cancer with promising results. Interventional radiologist Dr. Dan Bozarth explained, “Not all tumors respond to chemotherapy, so not using chemotherapy but instead using radiation…. it’s way better tolerated than some of the other therapies.” Using x-rays for guidance, the procedure involves inserting a catheter filled with beads of radiation into a blood vessel in the leg which feeds into a cancerous tumor. The beads contain the radioactive Isotope Yttrium 90, which is sent directly to the tumor through that blood vessel. This treatment has been recommended for patients who do not respond to chemotherapy.
Combination Therapy Trial For Locally Advanced, Metastatic HCC Underway
16 January 2020
CStone Pharmaceuticals and Blueprint Medicines Corporation are conducting a phase 1b/2 trial of fisogatinib in combination with CS1001 for the treatment of locally advanced or metastatic Hepatocellular Carcinoma (HCC). Fisogatinib is a potent and highly selective inhibitor of fibroblast growth factor receptor 4 which was discovered by Blueprint Medicines. Results from an ongoing phase 1 trial show that fisogatinib monotherapy was clinically active and well-tolerated in patients with heavily pretreated advanced HCC. CS1001 is an investigational anti-PD-L1 monoclonal antibody under development by CStone for multiple types of cancer.
Heterogeneity Of Liver Cancer Cells Helps Explain Tumor Progression In Patients
15 January 2020
Based on a report from a team of researchers at Mount Sinai, liver cancer tumors contain a diverse set of cells, known as intra-tumor heterogeneity, which can significantly affect the rate at which the cancer grows. They reported that this heterogeneity, either within the same tumor or between different tumor regions in the same tumor nodule, appears in about 30% of patients with Hepatocellular cancer (HCC). So far two phase II clinical trials using PD-1 immune checkpoint inhibitors, which help the body's immune system recognize and attack cancerous cells, have achieved positive results in humans. Another phase III clinical trial, which combined a PD-1 immune checkpoint inhibitor with an antiangiogenic, showed to improve survival when compared to sorafenib.
Two Cancer-Causing Genes Work Together To Promote Metastasis
14 January 2020
Two genes, MYC and TWIST1, have been previously identified to promote the growth and spread of cancer. Renumathy Dhanasekaran, a PhD student in the Division of Gastroenterology and Hepatology at Stanford University, states, “The main goal of our research is to understand how cancer-causing genes enable metastasis and use that information to identify targeted therapies that may prevent it.” Dhanasekaran and team genetically engineered mice to express MYC and TWIST1 and found that these two genes led to metastases. They also observed that the cancer cells produced inflammation-promoting molecules Ccl2 and Il13, which attract immune cells called macrophages and make them more tumor-cell friendly, making it easier for the cancer cells to migrate to new areas of the body. The team then monitored Ccl2 and Il13 levels in 25 patients with liver cancer and 10 control patients with cirrhosis. They found that only the patients with liver cancer had elevated levels of the two molecules and those with higher levels of Il13 were more likely to have aggressive tumors.
Encouraging Results In First Line Setting For HCC Usher Lenvatinib Toward Randomized Controlled Trials
13 January 2020
Currently, the recommended treatment for patients with intermediate-stage Hepatocellular Carcinoma (HCC) is transarterial chemoembolization (TACE). Unfortunately, TACE is not suitable for patients with high-tumor-burden HCC. Past research shows that lenvatinib has demonstrated significantly and clinically meaningful anticancer efficacy by reducing tumor size. In a recent trail, 30 patients previously treated with lenvatinib or TACE were observed. The median progression-free survival (PFS) was 16 months in the lenvatinib arm and 3 months in the TACE arm. The median overall survival (OS) was 37.9 months in the lenvatinib arm and 21.3 months in the TACE arm.
Trisalus™ Life Sciences Launches The New Trinav™ Infusion System, An Innovative Solution Designed To Overcome Infusion Barriers Within Solid Tumors
13 January 2020
TriNav™ Infusion System is the newest therapy enhancer designed by TriSalusTM Life Sciences, powered by its Pressure-Enabled Drug DeliveryTM (PEDD™) approach with SmartValveTM technology. TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumors in Hepatocellular Carcinoma (HCC). The tumor microenvironment creates pressure barriers that limit flow into solid tumors, but SmartValve creates a high-pressure gradient that improves delivery and penetration of therapy into tumors. The porous SmartValve is designed to use blood flow to carry the dose deep into a solid tumor. In a study, PEDD with SmartValve demonstrated the ability to overcome tumor infusion barriers and significantly improve response rates in HCC.
Machine Keeps Human Livers Alive For One Week Outside Of The Body
13 January 2020
A team of researchers from the University Hospital Zurich and the University of Zurich have developed a machine, which can repair an injured human liver and keeps it alive for one week outside the body. The system uses perfusion technology, imitating core body functions. During the study for safety and efficacy, the team found that six of ten poor-quality human livers, originally declined for transplantation were recovered to full function within one week of perfusion on the machine. This machine proves to be a breakthrough in transplantation medicine, increasing the number of available organs for transplantation and saving the lives of patients.
Dr. Janjigian On Data With Atezolizumab/Bevacizumab Combo In HCC
10 January 2020
Yelena Y. Janjigian, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center presents results from the ongoing phase III IMbrave150 trial at the 2019 ESMO Asia Congress. The study shows improvement in efficacy and toxicity with patients with Hepatocellular Carcinoma (HCC) who are treated with bevacizumab (Avastin) and atezolizumab (Tecentriq) when compared with sorafenib (Nexavar). Grade 3/4 adverse events were more common in the combination arm (57%) versus the sorafenib arm (55%).
New Investigation Into PD-1 Blockade For Hepatocellular Carcinoma
10 January 2020
A team of investigators are trying to determine why immunotherapy only works in select patients with Hepatocellular Carcinoma (HCC). The team is led by Thomas Marron, MD, PhD, assistant director of early-phase and immunotherapy trials at The Tisch Cancer Institute at Mount Sinai, New York, New York. Marron and his team are conducting a phase 1 clinical trial to assess the clinical efficacy and response of patients with HCC to cemiplimab therapy. Their research will include the evaluation of the therapeutic effects of the programmed death receptor 1 (PD-1) antibody (cemiplimab-rwlc), which was developed by Regeneron Pharmaceuticals, Inc, and Sanofi.
Hope Persists As Treatment Landscape For HCC Expands Dramatically
9 January 2020
Patients with Hepatocellular Carcinoma (HCC) now have 6 FDA approved treatment options for the second-line setting, with 4 targeted therapies and 2 immunotherapies. Results of the phase III CheckMate 459 trial demonstrated an improvement in overall survival (OS) with nivolumab (Opdivo) when compared with sorafenib (Nexavar). The phase III IMbrave150 trial demonstrated improved progression-free survival(PFS) and OS with the combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin) as compared with sorafenib. Also, in July of 2019, the FDA granted a breakthrough therapy designation to the combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima).
Innovent And Sirnaomics Entered Strategic Collaboration To Conduct Clinical Oncology Studies Combining Sintilimab And RNAi In The US
7 January 2020
Innovent Biologics, Inc. and Sirnaomics Inc., biopharmaceutical companies, have begun a collaboration to conduct clinical studies, using Innovent's antibody drug Tyvyt® (sintilimab injection) and Sirnaomics' RNAi drug candidate STP705 (cotsiranib), for combination treatment in advanced cancers Hepatocellular Carcinomas (HCC). Patrick Lu, PhD, President and CEO of Sirnaomics, stated, “This collaborative effort between Sirnaomics and Innovent will be the first example of a combination strategy using an RNAi drug candidate together with an approved immune checkpoint antibody drug for the treatment of liver cancers.”
Data From The Phase II Liver Cancer Study With Namodenoson Will Be Presented At The ISCORT Conference By Dr. Stemmer
7 January 2020
The principal investigator of the Phase II liver cancer study, Dr. Solomon Stemmer, of the biotechnology company Can-Fite BioPharma Ltd., will deliver a presentation titled “The Safety and Efficacy of Namodenoson in the Second-Line Treatment of Advanced Hepatocellular Carcinoma (HCC). Namodenoson is being evaluated as a second-line treatment for HCC with plans for a Phase III trial. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Results from the completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients.
CStone Pharmaceuticals And Blueprint Medicines Initiate Phase 1b/2 Clinical Trial Of Fisogatinib In Combination With CS1001 For Patients With Hepatocellular Carcinoma
6 January 2020
CStone Pharmaceuticals, a biopharmaceutical company, has begun its Phase 1b/2 trial evaluating fisogatinib in combination with CS1001 for the treatment Hepatocellular Carcinoma (HCC). Fisogatinib, discovered by Blueprint Medicines, is a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4). CS1001 is an anti-PD-L1 monoclonal antibody being developed by CStone. The trial will assess the potential for two complementary treatment approaches, precision therapy and immuno-oncology therapy, to increase anti-tumor activity. From the ongoing Phase 1 trial showed that fisogatinib monotherapy was clinically active and well-tolerated in patients with heavily pretreated advanced HCC. These results support fisogatinib's potential as the first molecular biomarker-driven targeted therapy in HCC.
New Data From Hadassah Medical Center Lab Show Can-Fite’s Namodenoson Induces Weight Loss
3 January 2020
According to Dr. Rifaat Safadi, head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at the Hadassah Medical Center, Namodenoson induces weight loss in experimental models and normalizes glucose levels. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for Hepatocellular Carcinoma (HCC). New studies of Namodenoson showed a significant decrease in weight in both high-fat diet mouse models and in diabetic rat models. Namodenoson also normalized glucose levels in a glucose tolerance test (GTT).
Study Underway To Evaluate Novel T-Cell Therapy For Hepatocellular Carcinoma
3 January 2020
There is currently a clinical trial in progress to assess the use of a new T-cell therapy for the treatment of advanced Hepatocellular Carcinoma (HCC). Daneng Li, MD, medical oncologist at City of Hope, said in a press release, “This approach engineers immune cells to directly attack a protein that is expressed in liver cancer. We are trying to individualize treatment for patients with advanced liver cancer.” Patients with HCC often overexpress AFP, a protein that is potentially an attractive target for HCC treatment. ET140202 ARTEMIS, by Eureka Therapeutics, is an engineered T-cell therapy for advanced HCC whereby autologous T cells are genetically modified to target the AFP-peptide and major histocompatibility complex.
First-In-World Procedure For Liver Cancer Restores Hope For Patients
1 January 2020
Often cancer cannot be treated because of either a biological or technical reason. There are many treatment options to treat locally advanced liver cancer, including ExVivo and ALPPS. Ex Vivo involves extracting the entire liver, clearing it of cancer, and transplanting it back into the patient. ALPPS is a technique in which the portion of the liver containing cancer is removed, and the healthy portion is left to regenerate. Researchers are working to combine the procedures. Ex Vivo-APLPS procedure requires a team of 25 professionals. First, the ALPPS procedure is performed and then a period of waiting to allow the healthy liver to grow to an acceptable size. Then the Ex Vivo component is done, which involves taking the entire liver out, removing the tumor and the afflicted vessels, and reconnecting residual blood vessels, in the form of an auto-transplantation.
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