© 2023 HSP News Service, L.L.C.
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...
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...
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...
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....
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...
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...
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...
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...
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...
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...
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...
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).
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).
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).
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...
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)...
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...
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...
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...
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...
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 ...
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...
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...
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, ...
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
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...
Researchers at the National Institutes of Health have developed a new test that may help identify individuals who may be likely to develop hepatocellular carcinoma. A study of the new approach was led by researchers at the National Cancer Institute (NCI). The findings were published in the journal...
Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools shows that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of...
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved two combination regimens: ramucirumab (Cyramza) was approved in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)...
On May 29, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The review of this application...
As reported by Ghassan K. Abou-Alfa, MD, and colleagues in The Lancet Oncology, the phase III ClarIDHy trial has shown that the isocitrate dehydrogenase-1 (IDH1) inhibitor ivosidenib improved progression-free survival vs placebo in patients with advanced IDH1-mutant chemotherapy-refractory...
On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug...
As reported in The New England Journal of Medicine by Richard S. Finn, MD, and colleagues, the phase III IMbrave150 trial has shown that anti–programmed cell death ligand 1 (PD-L1) plus anti-VEGF therapy with atezolizumab plus bevacizumab improved progression-free and overall survival vs sorafenib ...
Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses an exploratory analysis seeking to identify tumor-based molecular biomarkers that may be associated with clinical response or resistance to the combination treatment of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma (Abstract CT044).
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...
In a phase II trial reported in JAMA Oncology, Kim et al found that nivolumab showed antitumor activity in patients with advanced refractory biliary tract cancer. As noted by the investigators, there currently is no established second-line systemic treatment for biliary tract cancer. Study Details...
A randomized multicenter study of a combination of immunotherapy with a targeted therapy improved cancer control for some patients with biliary tract cancer, according to research presented by Yarchoan et al at the American Association for Cancer Research (AACR) Virtual Annual Meeting (Abstract...
In the fall of 2009, I began experiencing some abdominal discomfort, pain in my right shoulder, and severe fatigue that were easily explained away as the result of gallstones and by my career as a paramedic. I had many of the risk factors for gallbladder disease, and both my mother and sister...
On March 10, 2020, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was granted accelerated approval for treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.1-3 Supporting Efficacy Data The approval was based on findings in a cohort...
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or...
Aspirin may be associated with a reduction in the risk of developing several cancers of the digestive tract. The largest and most comprehensive analysis to date of the link between aspirin and digestive tract cancers, published by Bosetti et al in Annals of Oncology, found reductions in the risk of ...