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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, ...

Hepatobiliary Cancer

Dabrafenib Plus Trametinib for Patients With BRAF V600E–Mutated Cholangiocarcinoma

In a phase II trial reported by Vivek Subbiah, MD, and colleagues in The Lancet Oncology, the combination of dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor, achieved a 51% overall response rate in patients with BRAF V600E­–mutated cholangiocarcinoma. This trial represents the first...

Hepatobiliary Cancer
Immunotherapy

Novel Tremelimumab/Durvalumab Regimen Active in Advanced Hepatocelluar Carcinoma

A single priming dose of tremelimumab and durvalumab, followed by monthly durvalumab, showed clinical activity in a predominantly second-line advanced hepatocellular carcinoma population, in a study reported at the ESMO World Congress on Gastrointestinal Cancer Virtual 2020.1 In a study of 332...

Hepatobiliary Cancer
Immunotherapy

First-Line Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma

In a phase Ib trial reported in the Journal of Clinical Oncology, Richard S. Finn, MD, and colleagues found that the combination of lenvatinib and pembrolizumab produced durable responses in patients with unresectable hepatocellular carcinoma who had received no prior systemic chemotherapy. As...

Hepatobiliary Cancer
Immunotherapy

Combination Immunotherapy in Advanced Biliary Tract Cancers

In a subgroup analysis of an Australian phase II trial reported in JAMA Oncology, Klein et al found that the combination of nivolumab and ipilimumab was active in patients with advanced biliary tract cancers. Study Details The phase II trial is enrolling patients with advanced rare cancers. The...

Hepatobiliary Cancer
Immunotherapy

Phase Ib Trial of Atezolizumab With or Without Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma

The combination of atezolizumab and bevacizumab was recently approved by the U.S. Food and Drug Administration for the treatment of unresectable or metastatic hepatocellular carcinoma on the basis of findings from the phase III IMbrave150 trial, which showed superior overall and progression-free...

Hepatobiliary Cancer

Liver Transplantation After Tumor Downstaging in Patients With Hepatocellular Carcinoma

In an Italian phase IIb/III study reported in The Lancet Oncology, Mazzaferro et al found evidence that liver transplantation after tumor downstaging was associated with improved event-free and overall survival in patients with hepatocellular carcinoma. The study was closed early due to changes in...

Hepatobiliary Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma

On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label,...

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
Immunotherapy

IMbrave150 Trial: Atezolizumab Plus Bevacizumab Improves Survival in Unresectable Hepatocellular Carcinoma

As reported in The New England Journal of Medicine by Richard S. Finn, MD, of Jonsson Comprehensive Cancer Center, Geffen School of Medicine at the University of California, Los Angeles, and colleagues, the phase III IMbrave150 trial has shown that anti–programmed cell death ligand 1 (PD-L1) plus...

Hepatobiliary Cancer

ESMO World GI: Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor infigratinib resulted in a progression-free survival and...

Hepatobiliary Cancer

Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1–3 inhibitor infigratinib resulted in a progression-free survival and...

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