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Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....
Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...
For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...
Anthony B. El-Khoueiry, MD, of the University of Southern California, Norris Comprehensive Cancer Center, discusses two key phase III studies of first-line treatment in hepatocellular carcinoma: the LAUNCH trial, which explored lenvatinib combined with transarterial chemoembolization for advanced disease; and the HIMALAYA trial, which studied tremelimumab and durvalumab for unresectable disease. The latter trial may represent a new standard of care, according to Dr. El-Khoueiry.
Ghassan K. Abou-Alfa, MD, MBA, of Memorial Sloan Kettering Cancer Center and Weill Medical College at Cornell University, discusses phase III results of the HIMALAYA trial, which showed the combination of a single priming dose of tremelimumab added to durvalumab is superior to sorafenib for patients with unresectable hepatocellular carcinoma (Abstract 379).
Nilofer Saba Azad, MD, of Johns Hopkins Sidney Kimmel Cancer Center, assesses the findings from the phase III TOPAZ-1 trial, a study of durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Dr. Azad explains why the study sets a potential new standard of care of gemcitabine plus cisplatin and durvalumab in unselected patients.
In a single-institution phase II trial reported in The Lancet Gastroenterology & Hepatology, Marron et al found that neoadjuvant treatment with the PD-1 inhibitor cemiplimab-rwlc in patients with resectable hepatocellular carcinoma produced a high level of pathologic tumor necrosis at resection ...
Results from the randomized international phase III HIMALAYA trial showed that a combination of the anti–PD-L1 immunotherapy durvalumab plus the anti–CTLA-4 immunotherapy tremelimumab reduced the risk of death by 22% in patients with stage III or IV unresectable hepatocellular carcinoma compared to ...
Biliary tract cancer is a rare and often fatal disease comprised primarily of bile duct and gallbladder cancers; it is diagnosed in about 12,000 individuals each year in the United States. The cancer has a 5-year relative survival rate of 25% for localized intrahepatic bile duct cancers and just...
A clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with primary liver cancers using external-beam radiation therapy (EBRT). Evidence-based recommendations outline indications and optimal EBRT...
In a case-control genome-wide association study among persons of European ancestry reported in The Lancet Oncology, Trépo et al identified common genetic variants associated with the risk of alcohol-related hepatocellular carcinoma (HCC). Study Details The study involved a discovery cohort of 2,107 ...
In a Chinese phase III trial (FOHAIC-1) reported in the Journal of Clinical Oncology, Lyu et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; HAIC-FO) significantly prolonged overall survival vs sorafenib in patients with advanced...
Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-3121 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...
The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...
As reported in The Lancet Oncology by Thomas Yau, MD, and colleagues, the phase III CheckMate 459 trial has shown no improvement in overall survival with first-line nivolumab vs sorafenib in patients with advanced hepatocellular carcinoma. Study Details In the open-label trial, 743 patients not...
In an analysis from the Children’s Oncology Group study AHEP0731 reported in the Journal of Clinical Oncology, Trobaugh-Lotrario et al found that the presence of small cell undifferentiated histology elements did not appear to adversely affect outcomes in pediatric patients with hepatoblastoma....
A novel vaccine platform administered in combination with pembrolizumab appears to be safe and effective in patients with advanced hepatocellular carcinoma (HCC), according to data presented by Mark Yarchoan, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting...
In a Chinese single-institution cohort study reported in JAMA Surgery, Zhou et al found that the presence of somatic G12 KRAS variants was associated with poorer overall and disease-free survival in patients who had undergone curative resection of intrahepatic cholangiocarcinoma. Study Details The ...
In the phase II portion of a French phase II/III trial (PRODIGE 38 AMEBICA) reported in the Journal of Clinical Oncology, Phelip et al found that modified (m) FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) did not improve 6-month progression-free survival vs the combination of...
In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; FOLFOX-HAIC) improved overall survival vs transarterial chemoembolization (TACE) as first-line treatment for...
Patients with hepatocellular carcinoma (HCC) awaiting liver transplantation may benefit from noninvasive treatment with external-beam radiotherapy (EBRT) but are rarely given this therapy, according to a new analysis of U.S. national data. Findings were presented by Nima Nabavizadeh, MD, at the...
In a Korean phase IIb trial (NIFTY) reported in The Lancet Oncology, Yoo et al found that the addition of liposomal irinotecan to fluorouracil/leucovorin improved progression-free survival as a second-line treatment for patients with metastatic biliary tract cancer whose disease had progressed on...
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
In a phase II trial reported in The Lancet Oncology, Juan W. Valle, MD, and colleagues found that no progression-free survival benefit was achieved with the addition of either the VEGFR2 inhibitor ramucirumab or the MEK inhibitor merestinib to first-line cisplatin/gemcitabine chemotherapy in...
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...