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Combination Of Atezolizumab And Bevacizumab Shows Early Efficacy In Unresectable HCC
28 September 2019
According to 2 clinical trials, Atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) induced objective responses in patients with unresectable Hepatocellular Carcinoma (HCC). The first trial involved 104 patients with no prior therapy. In the second study, investigators randomized 119 patients with untreated HCC to the same combination or to atezolizumab only. Clinically meaningful responses were seen in more than one-third of patients. A randomized trial showed that the combination reduced the risk of disease progression or death by 45% versus atezolizumab alone. 37 patients had stable disease, resulting in a disease control rate of 71%.

ESMO: Opdivo Study Author Looks For Bright Spots In First-Line Liver Cancer Failure
27 September 2019
According to study author Thomas Yau, M.D., of the University of Hong Kong, the CheckMate 459 study of Opdivo did not fulfill its primary goal to help previously untreated liver cancer patients live longer. However, Opdivo beat Bayer's Nexavar, the current standard of care, when it came to complete response rate. Bristol had been hoping to challenge Nexavar, Bayer's long-standard therapy for Hepatocellular Carcinoma (HCC). Merck & Co. and Eisai's Lenvima won its first-line nod in August 2018, based on data showing Lenvima patients lived 13.6 months at the median, compared with Nexavar's 12.3 months.

Immunotherapy Improves Overall Survival For Hepatocellular Carcinoma
26 September 2019
New data presented from the CheckMate 459 study found that nivolumab may serve as an effective therapy option for patients with advanced Hepatocellular Carcinoma (HCC). These results were presented at the ESMO Congress 2019 in Barcelona, Spain on September 27, 2019. The phase 3 CheckMate 459 study randomized 743 patients with advanced HCC to nivolumab or sorafenib as first-line treatment. The median OS was 16.4 months for nivolumab and 14.7 months for sorafenib. The results also showed that the overall response rate was 15% for nivolumab, including 14 patients with complete response, and 7% for sorafenib, in which 5 patients who had complete response.

Protein Discovered by Scientists in Singapore Could Form Basis for New Types of Liver Cancer Treatment
26 September 2019
A protein called Agrin has been discovered by scientists from the Agency for Science Technology and Research’s (A*Star) Institute of Molecular and Cell Biology (IMCB) who were working in collaboration with researchers from Nanyang Technological University’s (NTU) Lee Kong Chian School of Medicine. Researchers stated that Agrin “plays a vital role in the development and spread of cancer cells to secondary organ sites such as the lungs.” they also found that the inhibition of Agrin led to a reduction in tumor size and progression. Going forward, the team will be investigating how targeting Agrin can prevent blood vessel formation in liver and other tumors.

Can Sorafenib Be Topped In Advanced Hepatocellular Carcinoma?
25 September 2019
According to the results of the randomized phase 3 CALGB 80802 clinical trial, sorafenib (Nexavar) plus doxorubicin (Adriamycin, Rubex) failed to improve survival in patients with advanced Hepatocellular Carcinoma (HCC) compared with sorafenib alone. The CALGB 80802 trial enrolled a total of 356 patients between 2010 and 2015 with locally advanced or metastatic HCC who did not receive systemic therapy. After a median follow-up of 36.1 months, the median overall survival was not statistically different between the sorafenib plus doxorubicin arm and sorafenib alone arm, 9.3 months vs 9.4 months, respectively. Also, the median progression-free survival was also not statistically different between the sorafenib plus doxorubicin arm and sorafenib alone arm, 4 months vs 3.7 months, respectively.

Auransa Presents New Preclinical Data On AU-409, A Novel, AI-Derived Drug Candidate For The Treatment Of Hepatocellular Carcinoma
24 September 2019
Auransa Inc. is developing AU-409, novel lead drug candidate being for the treatment of Hepatocellular Carcinoma (HCC). Auransa Inc. is an artificial intelligence (AI)-driven biotechnology company developing precision medicines. A team of researchers conducted in vivo studies to measure the antitumor activity of AU-409 in an orthotopic mouse model of HCC. The study results demonstrated promising antitumor activity. Tumor burden was reduced by 63%, and the treatment was well tolerated. The company expects to initiate first-in-human Phase 1 trials in the first half of 2020.

Upfront Rt Plus Nivolumab May Benefit Patients With Unresectable Hepatocellular Carcinoma
24 September 2019
According to new data presented at the 2019 American Society for Therapeutic Radiation Oncology (ASTRO) Annual Meeting, Combining nivolumab with radiation therapy (RT) may improve objective responses and outcomes in patients with unresectable Hepatocellular Carcinoma (HCC). The researchers retrospectively identified 84 patients who received both nivolumab and RT. 25 patients were analyzed who received upfront RT prior to/overlapping with nivolumab initiation and 9 patients receiving salvage RT for longer than 4 weeks following nivolumab initiation. With a median follow-up 17.8 months, among responders, the median duration of response was 9.8 months.

Cabometyx Superior To Stivarga As Second-Line Liver Cancer Treatment
24 September 2019
According to a study presented at the International Liver Cancer Association 2019 meeting, patients treated with Cabometyx as second-line therapy for patients with advanced Hepatocellular Carcinoma (HCC) who previously received Nexavar demonstrated superior progression-free survival and improved overall survival compared with Stivarga. In the CELESTIAL trial, cabozantinib improved median progression-free survival (5.2 vs. 1.9 months) and median overall survival (10.2 vs. 8 month) compared with placebo. The RESOURCE trials showed that cabozantinib improved progression-free survival (5.6 vs. 3.2 months) and numerically improved median overall survival (11.4 vs. 10.8 months) compared with regorafenib. “These results may support clinicians in making informed treatment decisions in order to deliver optimal care for their patients,” said Katie Kelley, MD, study investigator from the University of California, San Francisco.

On The Double: Immunotherapy Combinations In Liver Cancer
24 September 2019
Radioembolization is a treatment in which tiny beads filled with radioactive material are delivered through the hepatic arteries that feed the tumor. The procedure blocks the blood supply and delivers radiation to the tumor while sparing normal tissue. This treatment lowers alpha-fetoprotein (AFP) levels. AFP is used as a protein tumor marker because it is elevated in 60% to 70% of people with liver cancer. CheckMate-040 was a clinical trial in which patients received the immunotherapy medication Opdivo (nivolumab) alone or with another type of immunotherapy drug, Yervoy (ipilimumab), with or without Cabometyx (cabozantinib), a tyrosine kinase inhibitor that blocks some of the cellular signals that can stimulate cancer cell growth.

Study Suggests New Metabolic Target For Liver Cancer
23 September 2019
Research in a mouse model of liver cancer shows that disrupting a metabolic pathway in the liver in a way that creates a more “cancer-like” metabolism actually reduces tumor formation. The study, led by Eric Taylor, PhD, associate professor of biochemistry in the University of Iowa Carver College of Medicine, shows that the mitochondrial pyruvate carrier (MPC), a protein complex that is critical for glucose production in the liver, may represent a new target for preventing liver cancer. Taylor notes that these trials could provide important information about the safety and therapeutic contribution of altering MPC activity in people

Can-Fite Presents New Data On The Treatment Of Advanced Liver Cancer With Namodenoson At The ILCA Conference
23 September 2019
Dr. Michael Silverman, the Medical Director of Can-Fite BioPharma Ltd. presented “The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study” at the International Liver Cancer Association (ILCA). While the Phase II study did not achieve its primary endpoint of overall survival (OS) in the whole population, superiority in OS was found in a sub-population. Median OS was 6.8 months for those treated with Namodenoson as compared to 4.3 months for those treated with placebo.

Celsion Co-Sponsors Hepatocellular Carcinoma Symposium At The International Liver Cancer Association (ILCA) Annual Conference
23 September 2019
Celsion Corporation cosponsored a symposium focused on Hepatocellular Carcinoma (HCC) at the recent 13th Annual Conference of the International Liver Cancer Association (ILCA). The program was chaired by Ghassan Abou-Alfa, MD, MBA, Memorial Sloan Kettering Cancer Center and Professor. Dr. Abou-Alfa and Prof. Riccardo Lencioni, MD, FSIR, EBIR, have been involved in the development of Celsion’s lead product ThermoDox® for the treatment of HCC. “ThermoDox® is being studied as the first potential curative treatment for HCC in a large, randomized, multicenter Phase III trial,” said Prof. Lencioni.

AFP Response Could Assist In Cabozantinib Therapy Selection In HCC
22 September 2019
According to findings of a sub-analysis of the phase III CELESTIAL trial, patients with advanced Hepatocellular Carcinoma (HCC) treated with cabozantinib (Cabometyx) had higher alpha-fetoprotein (AFP) response rates versus those treated with placebo. Robin Katie Kelley, MD, explained that the positive outcomes are worth noting and warrant future research into AFP response. Normally, elevated levels of serum AFP have indicated poor prognosis across all stages of HCC. Results of the CELESTIAL trial showed that cabozantinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with previously treated advanced HCC, independent of baseline AFP.

Safety Of Nivolumab/Ipilimumab Combination Confirmed For Advanced HCC
21 September 2019
For those with advanced Hepatocellular Carcinoma (HCC), the CheckMate 040 study found that the combination of nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor, with ipilimumab (Yervoy), a CTLA-4 checkpoint inhibitor, can be effective. Anthony B. El-Khoueiry, MD and his team compared a total of 148 patients with advanced HCC who had previously been treated with first-line therapy sorafenib (Nexavar). The phase III CheckMate 9DW study, soon to begin, will compare nivolumab and ipilimumab against the standard of care.

Comparing Sorafenib And Lenvatinib For The Frontline Treatment Of Advanced HCC
20 September 2019
Both sorafenib (Nexavar) and lenvatinib (Lenvima) have been approved by the FDA for the treatment of patients with advanced Hepatocellular Carcinoma (HCC). Data from the REFLECT study showed that if a patient has a response with either agent, which could provide a survival of 22 months. Richard S. Finn, MD, professor of Clinical Medicine Division of Hematology/Oncology, UCLA David Geffen School of Medicine, University of California, Los Angeles, explains that he is more likely to give lenvatinib for bulky tumors or for patients with high alpha fetoprotein levels, or any other poor prognostic factors.

Phase I Study Results Show First-In-Class NBTXR3 Could Present As A Valuable Option For Patients With Hepatocellular Carcinoma Or Liver Metastasis
18 September 2019
NANOBIOTIX has had positive findings from their phase I study evaluating first-in-class radio enhancer NBTXR3 activated by stereotactic body radiation (SBRT). The population for this study included 11 Hepatocellular Carcinoma (HCC) patients with a minimum life expectancy of three months that were unsuitable for local surgery or local treatment. SBRT is a well-tolerated alternative therapy, however the dose is limited by hepatic function. NBTXR3 also proved to remain within the injected tumor with no leakage to surrounding tissue. NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy.

Surgical Oncologist Highlights Treatment Approaches For HCC Ahead Of ISGIO
18 September 2019
The treatment landscape for patients with advanced Hepatocellular Carcinoma (HCC) has advanced with several more options becoming available over the past few years. One option for patients with early-stage disease is ablation. This is where physicians can use a probe to freeze or burn out the cancer if it is in a favorable position, with either microwave or radiofrequency ablation. For patients with larger tumors, intra-arterial options are available. This is a treatment that uses beads that are embedded with either chemotherapy or radiation, such as yttrium-90 (Y-90). Y-90 and related treatments are able to attack the liver cancer directly.

Newly Discovered Biomarkers Suggest Who May Benefit From Liver Cancer Treatment
17 September 2019
A team of researchers at Roswell Park Comprehensive Cancer Center found a biomarker that may help to determine which patients with Hepatocellular Carcinoma (HCC) will respond to treatment with Nexavar (sorafenib). The study investigator Dr. Renuka Iyer, section chief for gastrointestinal oncology at Roswell Park stated that “Only recently, in the last two or three years, we've gotten five or six more drugs to treat liver cancer. And so, when you have the options, you want to know which patients are going to benefit from the one you've always had, and which patients you may want to consider something else or consider a combination therapy.” The team collected blood samples from 30 patients. They discovered that patients with elevated levels of a subset of CD8+ cytotoxic T-cells (cells they kill cancer cells) had better outcomes.

Lenvima To Get Benefit As 1st-Line Treatment Of Hepatocellular Carcinoma
16 September 2019
Lenvima (ingredient: lenvatinib) is a new liver cancer drug that may now benefit as a first-line treatment of Hepatocellular Carcinoma (HCC). The REFLECT trial on Lenvima evaluated the efficacy and safety of the drug, compared to Nexavar, in 954 patients in 20 countries with unresectable HCC. The Lenvima-treated group had 7.4-months in time to progression (TTP), whereas the Nexavar group had 3.7 months. Masatoshi Kudo, a professor of Kindai University was the chief researcher of the REFLECT study. The Health Insurance Review and Assessment Service (HIRA) stated that it would expand the reimbursement of Lenvima in the first-line treatment for patients with HCC who cannot undergo surgery or topical treatment.

Brit Invention Saves Transplant Patients' Lives By Keeping Livers ‘Alive' Outside Body
7 September 2019
A British invention, called the OrganOx, can keep human livers “alive” outside the body which are ready to be used for transplant. This device doubles the “shelf life” of a donor liver and reduces the risk of tissue damage, and so far, saving 500 patients facing death while waiting for a suitable donor. It was created by transplant experts, Prof Peter Friend and Prof Constantin-Coussios. Prof Joerg-Matthias Pollok, the head transplant surgeon at Royal Free said, “Having the machine buys us time to test the liver and make sure it is functioning well, which means there isn’t the rush to transplant often late at night or in the early hours. It takes the pressure off.”

Assessment Of Treatment With Sorafenib Plus Doxorubicin Vs Sorafenib Alone In Patients With Advanced Hepatocellular Carcinoma
7 September 2019
Previous studies have shown significant improvement in overall survival (OS) when using doxorubicin plus sorafenib in the treatment of advanced hepatocellular cancer (HCC). In a randomized phase 3 clinical trial led by Alliance with 356 patients, median OS was 9.3 months in the doxorubicin plus sorafenib arm and 9.4 months in the sorafenib alone arm. The median progression-free survival (PFS) was 4 months in the doxorubicin plus sorafenib arm and 3.7 months in the sorafenib alone arm. The study began in February 2010 and was completed in May 2015, with OS as the primary endpoint.

Real-Time ctDNA Evaluation In Patients With Hepatocellular Carcinoma
6 September 2019
A recently published study involved patients with Hepatocellular Carcinoma (HCC) undergoing circulating tumor DNA (ctDNA) testing. Over a 3-year period, 45 samples were collected from 35 patients. The median number of genetic alterations per samples was 3.5. A total of 122 unique alterations were identified. The team of researchers stated, “[ctDNA assessment] holds incredible promise for early detection of disease … and evaluation of treatment response and mechanisms of resistance.”

Scientists Confirm Efficacy Of A Combination Therapy For Advanced Liver Cancer
5 September 2019
Although sorafenib improves overall survival (OS)in patients with advanced Hepatocellular Carcinoma (HCC), researchers question what can increase its effectiveness. Scientists began to test whether a radiological procedure called transarterial chemoembolization (TACE) could increase patient survival. A team from Taiwan and Japan, led by Dr Victor Kok from Kuang Tien General Hospital Cancer Center and Asia University Taiwan, performed the first large, national-level, population-based cohort study. After tracking the data of 2112 Taiwanese patients, the team identified a 26% decrease in mortality when TACE was added to sorafenib treatment, compared with sorafenib treatment alone.

Laboratory For Advanced Medicine's Liver Cancer Test Gets FDA Breakthrough Tag
4 September 2019
The FDA has granted breakthrough status to liver cancer liquid biopsy, created by Laboratory for Advanced Medicine (LAM). According to American Cancer Society, the existing blood test for liver cancer which detects alpha-fetoprotein (AFP), is flawed. The limitations of AFP and other screening techniques in early stage detection matter as the outcomes of liver cancer patients improve if the disease is treated when the tumor is small and localized. LAM’s approach is to use the DNA methylation alterations involved in tumorigenesis to detect cancer in its early stages. This method entails isolating cell-free DNA (cfDNA) from blood samples and analyzing it to identify DNA methylation patterns specific to HCC.

Tiziana Life Sciences Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity With Milciclib Monotherapy In Advanced Sorafenib-Refractory Or -Intolerant Patients With Unresectable Or Metastatic Hepatocellular Carcinoma
4 September 2019
Tiziana Life Sciences plc is a biotechnology company focusing on the discovery and development of innovative therapeutics oncology. They currently have a Phase 2a study observing patients with unresectable Hepatocellular Carcinoma (HCC) and their Milciclib monotherapy. The study has shown that Milciclib was well tolerated with manageable toxicities and no recorded drug related deaths. The trial enrolled 28 patients in Italy, Greece and Israel. 14 out of 28 patients completed a 6-month duration of the trial. Both median time to progression (TTP) and progression-free survival (PFS) were 5.9 months. 18 of 28 patients showed Clinical Benefit Rate.

Liver Transplant Candidates With Public Insurance Have Worse Waitlist Outcomes Than Those With Private Insurance
3 September 2019
According to a study by researchers at UC San Francisco, patients on the waitlist for a liver transplant had significantly worse outcomes with public insurance compared to Kaiser Permanente or other private insurance. Liver transplant is the best treatment for Hepatocellular Carcinoma (HCC), though about 15% – 30% of candidates drop out from the waitlist within a year of being listed, primarily due to organ scarcity and cancer progression. African Americans have twice the HCC incidence rate as whites but are also the least likely to undergo potentially curative treatment. Neil Mehta, MD, UCSF Health gastroenterologist and associate professor of gastroenterology at UCSF, stated that “Public insurance should be recognized as a risk factor associated with waitlist dropout, and necessary steps should be implemented to mitigate the increased risk of dropout among these patients.”


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