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Hepatobiliary Cancer

FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma

On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...

Hepatobiliary Cancer
Immunotherapy

Pertuzumab and Trastuzumab in Previously Treated Patients With HER2-Positive Metastatic Biliary Tract Cancer

As reported in The Lancet Oncology by Milind Javle, MD, and colleagues, findings in a cohort of the phase IIa MyPathway multiple basket study showed that the combination of pertuzumab and trastuzumab produced responses in some previously treated patients with HER2-positive metastatic biliary tract...

Hepatobiliary Cancer
Immunotherapy

Tremelimumab, Durvalumab, or Both in Unresectable Hepatocellular Carcinoma

In a randomized expansion phase of a phase I/II study reported in the Journal of Clinical Oncology, Robin Kate Kelley, MD, and colleagues found that a novel regimen consisting of a single priming dose of tremelimumab in combination with durvalumab was associated with good outcomes in patients with...

Hepatobiliary Cancer
Immunotherapy

Neoadjuvant Cabozantinib/Nivolumab May Make Resection Possible for Some Patients With Liver Cancer

A combination of the kinase inhibitor cabozantinib and the immunotherapy nivolumab may make curative surgery possible for some patients with liver cancer who would generally not be considered candidates for surgery, according to research published by Ho et al in Nature Cancer. Rates of Resection...

Hepatobiliary Cancer

Donafenib May Improve Survival vs Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma

In a Chinese phase II/III trial reported in the Journal of Clinical Oncology, Qin et al found that donafenib, a multikinase inhibitor and deuterated sorafenib derivative, improved overall survival vs sorafenib in the first-line treatment of unresectable or metastatic hepatocellular carcinoma. As...

Hepatobiliary Cancer
Immunotherapy

Patient-Reported Outcomes From the IMbrave150 Trial in Advanced Hepatocellular Carcinoma

In an analysis from the phase III IMbrave150 trial reported in The Lancet Oncology, Peter R. Galle, MD, and colleagues found that patients receiving atezolizumab plus bevacizumab had better patient-reported outcomes vs those receiving sorafenib for advanced unresectable or metastatic hepatocellular ...

COVID-19
Issues in Oncology
Lung Cancer
Hepatobiliary Cancer

Selected Poster Presentations From the NCCN 2021 Annual Conference

Although once again, the National Comprehensive Cancer Network® (NCCN®) 2021 Annual Conference could not take place on site in Orlando, researchers presented their work virtually in the form of almost 100 posters. The ASCO Post has summarized some that we found particularly interesting. Many...

Hepatobiliary Cancer
Genomics/Genetics

FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...

Hepatobiliary Cancer
Genomics/Genetics

Actionable Mutations Identified in Majority of Genome-Sequenced Resected Cholangiocarcinomas

Tumor genomic profiling of resected cholangiocarcinomas may reveal mutations targetable with agents currently being used for other cancers, according to the results of a study presented at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 Among patients...

Issues in Oncology
Immunotherapy
Breast Cancer
Bladder Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer

FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies

In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...

Hepatobiliary Cancer

Does Long-Term Suppression of Hepatitis B in Patients With HIV Lower Risk of Hepatocellular Carcinoma?

While the risk of hepatocellular carcinoma (HCC) is higher among patients who have human immunodeficiency virus (HIV), it’s even higher among patients who have HIV and detectable hepatitis B, according to research published by Kim et al in Hepatology. Among patients with HIV and hepatitis B,...

Kidney Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Kidney and Endometrial Cancers, Cholangiocarcinoma

Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...

Hepatobiliary Cancer

Expert Point of View: Ezra E.W. Cohen, MD

Formal discussant of the ­FOENIX-CCA2 trial, Ezra E.W. Cohen, MD, of the University of California San Diego and Moores Cancer Center, was encouraged by the findings with highly selective targeted agents such as futibatinib and emphasized the importance of molecular profiling. “The molecular...

Hepatobiliary Cancer

Phase II Trial Reports Anticancer Activity With Novel FGFR Inhibitor in Advanced Intrahepatic Cholangiocarcinoma

Futibatinib—a selective, fibroblast growth factor receptor (FGFR) inhibitor—demonstrated anticancer activity in patients with advanced intrahepatic cholangiocarcinoma and FGFR2 fusions or rearrangements. These findings are based on the primary results of the phase II FOENIX-CCA2 trial, which were...

Gastrointestinal Cancer
Gastroesophageal Cancer
Hepatobiliary Cancer
Immunotherapy

More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer

More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...

Bladder Cancer
Gynecologic Cancers
Hepatobiliary Cancer
Solid Tumors
Colorectal Cancer
Immunotherapy

FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More

Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...

hepatobiliary cancer

Lipika Goyal, MD, on Treating Intrahepatic Cholangiocarcinoma With Futibatinib

Lipika Goyal, MD, of Massachusetts General Hospital, discusses phase II results of the FOENIX-CCA2 trial, which explored the clinical benefit of futibatinib, an FGFR1–4 inhibitor, tested in patients with intrahepatic cholangiocarcinoma that harbored FGFR2 gene fusions or other rearrangements (Abstract CT010).

hepatobiliary cancer
immunotherapy

Richard S. Finn, MD, on Treating Hepatocellular Carcinoma With Atezolizumab, Bevacizumab, and Sorafenib

Richard S. Finn, MD, of UCLA Medical Center, discusses updated efficacy and safety data from the IMbrave150 trial of patients receiving atezolizumab plus bevacizumab vs sorafenib as first-line treatment for unresectable hepatocellular carcinoma (Abstract CT009).

Pancreatic Cancer
Hepatobiliary Cancer
Colorectal Cancer
Breast Cancer
Skin Cancer
Lung Cancer
Prostate Cancer
Issues in Oncology

Estimated Shifts in Cancer Incidence and Death Over Next 2 Decades

In the next 2 decades, rankings of incidence and death across cancer types in the United States will undergo important changes, according to new research published by Lola Rahib, PhD, and colleagues in JAMA Network Open. The study estimates that pancreatic cancer is on course to become the...

Hepatobiliary Cancer

Second-Line FOLFOX vs Active Symptom Control in Advanced Biliary Tract Cancer

In the phase III ABC-06 trial reported in The Lancet Oncology, Angela Lamarca, PhD, and colleagues found that second-line FOLFOX (leucovorin, fluorouracil [5-FU], and oxaliplatin) produced a statistically significant improvement in median overall survival vs active symptom control in patients with...

Hepatobiliary Cancer
Immunotherapy

Meta-analysis Finds Liver Tumors May Be Resistant to Immunotherapy in Patients With Underlying Nonalcoholic Steatohepatitis

Immunotherapy is not only significantly less effective in patients with liver cancer who previously had nonalcoholic steatohepatitis, but it actually may fuel tumor growth, according to a study published by Pfister et al in Nature. Nonalcoholic steatohepatitis affects as many as 40 million people...

Hepatobiliary Cancer

Cholangiocarcinoma: Often Misdiagnosed, Always Impactful

A large survey of patients with cholangiocarcinoma indicates the toll this cancer takes on patients, even those with early-stage disease, as reported at the 2021 Gastrointestinal Cancers Symposium by Kristen Bibeau, PhD, MSPH, Head of Global Health Outcomes and Real-World Evidence Generation at...

Hepatobiliary Cancer

Novel CK2 Inhibitor Silmitasertib Shows Promise in Cholangiocarcinoma

A novel inhibitor of casein kinase 2 (CK2) has shown preliminary evidence of efficacy in patients with locally advanced or metastatic cholangiocarcinoma, according to a phase I/IIb study presented at the 2021 Gastrointestinal Cancers Symposium.1  Silmitasertib (CX-4945) is an oral small-molecule...

Hepatobiliary Cancer
Genomics/Genetics

In Cholangiocarcinoma, Does Chemotherapy Response Vary According to FGFR2 Status?

With inhibitors of fibroblast growth factor receptor 2 (FGFR2) fusion and other genetic alterations now in clinical trials for cholangiocarcinoma, there is interest in better understanding what FGFR2 genetic alterations mean for patients. In particular, little is known about the effects of FGFR2...

Hepatobiliary Cancer

Expert Point of View: Rachna T. Shroff, MD, and Gentry King, MD

Invited study discussant Rachna T. Shroff, MD, Associate Professor of Medicine, University of Arizona, and Chief of GI Medical Oncology at the University of Arizona Cancer Center, said the study presented by Dr. Javle showed the FGFR2 inhibitor infigratinib to be active in FGFR2 fusion–positive...

Hepatobiliary Cancer

FGFR2 Inhibitor Infigratinib Active in Chemotherapy-Refractory Cholangiocarcinoma

The novel targeted agent infigratinib (BGJ398) showed clinically meaningful activity against chemotherapy-refractory cholangiocarcinoma in patients with fibroblast growth factor receptor (FGFR2) fusions and rearrangements. The confirmed overall response rate was 23% (34% confirmed/unconfirmed), the ...

Hepatobiliary Cancer

Expert Point of View: Rachna T. Shroff, MD

Invited discussant of the ClarIDHy trial, Rachna T. Shroff, MD, Associate Professor of Medicine, University of Arizona, and Chief of GI Medical Oncology at the University of Arizona Cancer Center, said positive findings for ivosidenib support the notion that “biliary cancer is a perfect example of...

Hepatobiliary Cancer

ClarIDHy Trial: IDH1 Inhibitor Ivosidenib Improves Survival in Cholangiocarcinoma

Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months in previously treated patients with advanced IDH1-mutated cholangiocarcinoma, compared with placebo, researchers of the global phase III ClarIDHy trial reported at the 2021 Gastrointestinal...

Hepatobiliary Cancer
Immunotherapy

IMbrave150: A New Standard of Care to Treat Hepatocellular Cancers?

In 2007, sorafenib became the first approved systemic therapy for hepatocellular cancers and the first agent to improve overall survival in these patients.1 In a similar multikinase inhibitor strategy, lenvatinib was found to be noninferior to sorafenib in overall survival in the same patient...

Hepatobiliary Cancer
Global Cancer Care

Study Establishes Global Burden of Gallbladder and Biliary Tract Cancer

Although cancers of the gallbladder or bile ducts are rare, their rates of occurrence are increasing. A recent study published by Ouyang et al in the journal Cancer provided details on the burden of gallbladder and biliary tract cancer across 195 countries and territories from 1990 to 2017....

Hepatobiliary Cancer

FDA Approves TheraSphere Y-90 Glass Microspheres for Unresectable Hepatocellular Carcinoma

Today, the U.S. Food and Drug Administration (FDA) approved TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma. The approval expands access to this therapy, which, to date, has been utilized under a humanitarian device exemption—an FDA...

Breast Cancer
Bladder Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer
Lung Cancer
Immunotherapy

FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval

Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...

Hepatobiliary Cancer
Genomics/Genetics

In Cholangiocarcinoma, Does Chemotherapy Response Vary According to FGFR2 Status?

With inhibitors of fibroblast growth factor receptor 2 (FGFR2) fusion and other genetic alterations now in clinical trials for cholangiocarcinoma, there is interest in better understanding what FGFR2 genetic alterations mean for patients. In particular, little is known about the effects of FGFR2...

Hepatobiliary Cancer
Genomics/Genetics

Oncologist Survey Identifies Knowledge Gaps in Cholangiocarcinoma Mutations

In the treatment of cholangiocarcinoma, many clinicians may be unaware of the importance of the major oncogenic mutations and other alterations that can be identified and targeted, according to a survey of oncologists presented at the 2021 Gastrointestinal Cancers Symposium.1 “Recent developments...

Hepatobiliary Cancer

Expert Point of View: Rachna T. Shroff, MD

Invited discussant of the ClarIDHy trial, Rachna T. Shroff, MD, Associate Professor of Medicine, University of Arizona, and Chief of GI Medical Oncology at the University of Arizona Cancer Center, said positive findings for ivosidenib support the notion that “biliary cancer is a perfect example of...

Hepatobiliary Cancer

ClarIDHy Trial: IDH1 Inhibitor Ivosidenib Benefits Survival in Cholangiocarcinoma

Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months in previously treated patients with advanced IDH1-mutated cholangiocarcinoma, compared with placebo, researchers of the global phase III ClarIDHy trial reported at the 2021 Gastrointestinal...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Bladder Cancer
Skin Cancer
Sarcoma
Hepatobiliary Cancer

FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer

The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...

hepatobiliary cancer

Andrew X. Zhu, MD, PhD, on IDH1-Mutant Cholangiocarcinoma: Ivosidenib vs Placebo

Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses final results from the phase III ClarIDHy study, which showed that ivosidenib may improve overall and progression-free survival compared with placebo in patients with previously treated cholangiocarcinoma and an isocitrate dehydrogenase 1 mutation (Abstract 266).

hepatobiliary cancer
immunotherapy

Richard S. Finn, MD, on HCC: Atezolizumab Plus Bevacizumab vs Sorafenib

Richard S. Finn, MD, of the UCLA Medical Center, discusses updated results from the IMbrave 150 study, which showed atezolizumab plus bevacizumab provides the longest overall survival seen in a front-line phase III study in advanced hepatocellular carcinoma, confirming this combination as the standard of care for patients with previously untreated, unresectable disease (Abstract 267).

hepatobiliary cancer

Milind M. Javle, MD, on Cholangiocarcinoma: Treatment With Infigratinib

Milind M. Javle, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results showing that the novel tyrosine kinase inhibitor infigratinib may prove to be effective in treating patients with advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement (Abstract 265).

Hepatobiliary Cancer

IDH Inhibitor Ivosidenib Improves Overall Survival in Previously Treated Patients With Cholangiocarcinoma: ClarIDHy Trial

Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months compared with placebo in previously treated patients with advanced IDH1-mutated cholangiocarcinoma. Researchers presented results from the global phase III ClarIDHy trial at the 2021...

Hepatobiliary Cancer
Immunotherapy

Meta-analysis of Outcomes With Systemic Therapy in First- and Second-Line Treatments of Advanced HCC

In a systematic review and network meta-analysis reported in JAMA Oncology, Mohamad Bassam Sonbol, MD, of Mayo Clinic Cancer Center, Phoenix, and colleagues, found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma (HCC)...

Hepatobiliary Cancer
Immunotherapy

ASCO Releases Guideline on Systemic Therapy for Advanced Hepatocellular Carcinoma

ASCO has released a new evidence-based clinical practice guideline to assist in clinical decision-making for patients with advanced hepatocellular carcinoma.1 “Advanced hepatocellular carcinoma has transitioned from a disease where we had a single approved therapy for patients to one where we now...

Lymphoma
Leukemia
Hepatobiliary Cancer
Symptom Management
Lung Cancer
Immunotherapy

FDA Pipeline: Agents in DLBCL, SCLC, AML, and More

Recently, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions for agents to treat diffuse large B-cell lymphoma (DLBCL), small cell lung cancer (SCLC), acute myeloid leukemia (AML), biliary tract cancer, and graft-vs-host disease. Priority Review for Loncastuximab Tesirine...

Hepatobiliary Cancer
Immunotherapy

ESMO Asia 2020: First-Line Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma

Sintilimab, an anti–PD-1 antibody, in combination with a bevacizumab biosimilar as first-line therapy significantly improved survival compared to sorafenib in patients with advanced hepatocellular carcinoma, according to findings presented by Ren et al at the ESMO Asia Virtual Congress 2020...

Hepatobiliary Cancer

ESMO Asia 2020: Futibatinib for Patients With Refractory Intrahepatic Cholangiocarcinoma and FGFR2 Fusions/Rearrangements

Clinical benefit was provided by the FGFR1–4 inhibitor futibatinib in patients with refractory intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements, including those enrolled in Asian countries. These findings were presented by Furuse et al at the ESMO Asia Virtual...

Hepatobiliary Cancer

Addition of Ablative Therapy to Transarterial Chemoembolization in Nonmetastatic Unresectable Hepatocellular Carcinoma

In a single-institution cohort study reported in JAMA Network Open, English et al found that the addition of ablative therapy to transarterial chemoembolization improved freedom from local disease progression and overall survival in patients with nonmetastatic unresectable hepatocellular ...

Hepatobiliary Cancer
Pancreatic Cancer

FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers. Fast Track Designation for SRF388 in Liver Cancer The FDA granted Fast Track designation to SRF388 for the treatment of patients with...

Hepatobiliary Cancer
Immunotherapy

Systemic Therapy in the First- and Second-Line Treatment of Advanced Hepatocellular Carcinoma: Review and Meta-analysis

In a systematic review and network meta-analysis of 14 trials reported in JAMA Oncology, Sonbol et al found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma and identified preferred treatments in refractory disease. As...

Hepatobiliary Cancer

2020 Nobel Prize in Physiology or Medicine Awarded to Team Who Discovered Hepatitis C Virus

This year’s Nobel Prize in Physiology or Medicine was awarded to three scientists who have made a decisive contribution to the fight against blood-borne hepatitis, a major global health problem that causes cirrhosis and liver cancer in people around the world. Harvey J. Alter, MD; Michael Houghton, ...

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