© 2023 HSP News Service, L.L.C.
As reported in JAMA Oncology by Andrew X. Zhu, MD, PhD, and colleagues, the final overall survival analysis of the pivotal phase III ClarIDHy trial showed prolonged overall survival with ivosidenib vs placebo in previously treated patients with unresectable or metastatic cholangiocarcinoma and an...
Historically, rates of hepatocellular carcinoma (HCC) have been lower in rural areas than urban regions. However, a recent study published by Zhou et al in Clinical Gastroenterology and Hepatology shows that while cases of HCC have begun slowing in urban communities in the United States, the...
On August 25, 2021, ivosidenib was approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Oncomine Dx Target Test as a...
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 ...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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,...
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...
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...
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...
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...
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...
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).
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).
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...
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...
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...
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...
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...
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...
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...
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 ...
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 ...