An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...
The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...
The European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona featured several groundbreaking trials with the potential to significantly influence clinical practice. These studies highlighted the benefits of new combination immunotherapy strategies and innovative approaches in the...
The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors. For comprehensive reviews of these studies and more, visit ASCOPost.com. Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer In the phase...
At the 2024 American Association for Cancer Research (AACR) Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, Rebecca D. Kehm, PhD, of Columbia University Mailman School of Public Health, New York, and colleagues presented some of the ...
The National Medical Products Administration (NMPA) of China has accepted a supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with the multikinase inhibitor anlotinib for the first-line treatment of advanced hepatocellular carcinoma...
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also approved ...
In a phase II trial (IMbrave151) reported in the Journal of Clinical Oncology, Macarulla et al found that atezolizumab/bevacizumab plus chemotherapy produced a “modest” improvement in progression-free survival vs atezolizumab/placebo plus chemotherapy in first-line treatment of patients with...
Attendees at the European Society for Medical Oncology (ESMO) Congress 2024 heard the results of many positive clinical trials that will advance the field of cancer treatment. However, a few late-stage trials of promising adjuvant therapies unexpectedly reported negative results. The ASCO Post...
In an analysis reported in The Lancet Oncology, D’Alessio et al found that major pathologic response and complete pathologic response to neoadjuvant immune checkpoint inhibitor therapy was associated with improved relapse-free survival in patients with hepatocellular carcinoma. Study Details The...
A newly described stage of lymph node–like structures, known as tertiary lymphoid structures, identified in hepatic tumors following presurgical immunotherapy may be vital to successfully treating patients with hepatocellular carcinoma, according to a recent study published by Shu et al in Nature...
Researchers found that a higher dosage of radioembolization treatment using yttrium (Y)-90 microspheres than previously recommended may benefit patients with hepatocellular carcinoma, according to a recent study published by Chen et al in Liver Cancer. The findings could be practice-changing....
In the European TransMet trial, reported in The Lancet, Adam et al found that liver transplantation plus chemotherapy improved overall survival vs chemotherapy alone in patients with permanently unresectable colorectal cancer liver metastases. Study Details In the open-label trial, 94 patients...
The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...
An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...
Maeve Lowery, MD, discusses the results of the phase II DUBHE-H-308 trial, which evaluated QL1706—a bifunctional antibody consisting of iparomlimab and tuvonralimab—plus bevacizumab and/or chemotherapy in the first-line treatment of advanced hepatocellular carcinoma (Abstract LBA38).
As reported in The Lancet Oncology by Laura A. Dawson, MD, of the University Health Network–Princess Margaret Cancer Centre, University of Toronto, and colleagues, the Canadian phase III CCRG HE1 trial showed that the addition of a single fraction of palliative radiotherapy to best supportive care...
Josep M. Llovet, MD, PhD, presented the results of the LEAP-012 trial during the Presidential Symposium I at the ESMO Congress 2024 (Abstract LBA3). In this brief summary, Dr. Llovet talks further about how management of hepatocellular carcinoma differs across stages.
Josep M. Llovet, MD, PhD, presented the results of the phase III LEAP-012 trial, which evaluated the addition of lenvatinib plus pembrolizumab to transarterial chemoembolization (TACE), during the Presidential Symposium I at the ESMO Congress 2024 (Abstract LBA3). For more insights into the treatment of hepatocellular carcinoma, view Dr. Llovet's discussion here.
In light of the landmark 5-year overall survival results from HIMALAYA, Ghassan K. Abou-Alfa, MD, MBA, FASCO, of Memorial Sloan Kettering Cancer Center, New York, and Lorenza Rimassa, MD, discuss how to choose among the various doublet immunotherapy options for unresectable hepatocellular carcinoma. For more on the HIMALAYA trial, view part 1 of this discussion.
Ghassan K. Abou-Alfa, MD, MBA, FASCO, of Memorial Sloan Kettering Cancer Center, New York, and Lorenza Rimassa, MD, of Humanitas Cancer Center, Milan, discuss the 5-year overall survival results from the phase III HIMALAYA trial evaluating tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (Abstract 947MO). For more on the HIMALAYA trial, view part 2 of this discussion. �
An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, has confirmed the robust benefit for the STRIDE regimen of durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 At the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract...
According to results of the first interim analysis of the phase III LEAP-012 trial, the anti–PD-1 therapy pembrolizumab plus the tyrosine kinase inhibitor lenvatinib, in combination with transarterial chemoembolization (TACE), significantly improved progression-free survival compared with TACE...
In an Indian phase II trial (BEER BTC) reported in the Journal of Clinical Oncology, Ramaswamy et al found that maintenance therapy with bevacizumab/erlotinib improved progression-free survival vs active surveillance in patients with advanced biliary tract cancers who had at least stable disease...
Hepatocellular carcinoma is the most common type of primary liver cancer, accounting for about 80% of all primary liver cancers in the United States, and is currently the sixth most common cancer and the fourth most common cause of cancer-related deaths. Although immunotherapy is now a mainstay for ...
Certain patients with colorectal cancer that has metastasized to the liver may experience improved progression-free survival with liver transplantation compared with standard therapies, according to a recent study published by Byrne et al in JAMA Surgery. Background Colorectal cancer often...
Investigators examined whether nonstatin cholesterol-lowering drugs may affect the risk of hepatic cancer, according to a recent study published by Zamani et al in Cancer. Background Hepatic cancer is the sixth most common cancer type across the world and the third leading cause of cancer-related...
Fecal microbiota transplants may improve the effectiveness of immunotherapy in patients with gastrointestinal cancers, according to a recent study published by Kim et al in Cell Host & Microbe. Background Although immune checkpoint inhibitors have revolutionized cancer treatment, many patients...
This is Part 3 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of localized hepatocellular carcinoma. The patient is a 52-year-old male with a history of hepatitis C virus that has been treated and is in remission. Follow-up surveillance imaging reveals a 5.2-cm liver mass that washes out. His AFP is 6.2, and labs are within normal limits. His ECOG performance status is 1, and he has no history of alcohol or drug use. In the conversation that follows, the faculty discuss the multidisciplinary management of localized hepatocellular carcinoma, whether resection or transplant should be considered, and adjuvant treatment options for high-risk disease.
This is Part 2 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced cholangiocarcinoma. The patient is a 70-year-old female with no major medical history who presents to the ER after an acute episode of nausea/vomiting and abdominal pain. An MRI reveals a large liver mass with multiple satellite nodules, a hallmark of cholangiocarcinoma. Her labs are within normal limits with the exception of some mild electrolyte abnormalities, and her CA 19-9 is 473. A biopsy of the liver mass reveals moderately differentiated adenocarcinoma that is CK7-positive, CK20-negative, and HepPar1-negative. She presents to oncology for further management, where her physical exam is within normal limits and her ECOG performance status is 0. In the conversation that follows, the faculty discuss next steps in the diagnostic workup of this patient, the role of next-generation sequencing in determining the course of treatment, and current first- and second-line therapies for unresectable cholangiocarcinoma.
This is Part 1 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced unresectable hepatocellular carcinoma. The patient is a 67-year-old male with a history of fatty liver disease who presents with abdominal and back pain. Past medical history includes diabetes and hypertension, but no hepatitis. Labs show mild anemia but otherwise normal CBC and chemistries; liver function tests are normal other than mild AST/ALT elevation; and AFP is 47.3. MRI of the abdomen reveals multiple lesions in the liver, and a CT reveals lesions along the spine. The patient presents to oncology for further management, where his physical exam is within normal limits and his ECOG performance status is 1. In the conversation that follows, the faculty discuss current first-line immunotherapy options for hepatocellular carcinoma, including the STRIDE regimen and atezolizumab/bevacizumab; how to balance the risks and benefits of immune checkpoint inhibitors; and what to do after disease progression.
In a retrospective study reported in JAMA Oncology, Fulgenzi et al found evidence that immune checkpoint inhibitor (ICI)-based treatment may improve survival vs best supportive care as first-line therapy in patients with unresectable hepatocellular carcinoma and Child-Pugh class B (CP-B) liver...
In an Indian phase II trial (GECCOR-GB) reported in JAMA Oncology, Ostwal et al found that both adjuvant gemcitabine/cisplatin (GC) and capecitabine and capecitabine given concurrently with chemoradiation therapy (CCRT) showed activity in patients with resected gallbladder cancer. Study Details In...
Based on the results of the multicenter phase II NIFE-AIO-YMO HEP-0315 trial, which were reported in the Journal of Clinical Oncology by Ettrich et al, first-line palliative treatment with nanoliposomal irinotecan plus fluorouracil and leucovorin appears to be safe and active in patients with...
Investigators have uncovered the potential benefit of undergoing alcohol rehabilitation and maintaining abstinence in patients with alcohol dependence at risk of developing alcohol-associated cancers, according to a recent study published by Schwarzinger et al in The Lancet Public Health. The...
A serum fusion-gene machine-learning model may offer early diagnostic accuracy and could help improve the 5-year survival rate in patients with hepatocellular carcinoma, according to a recent study published by Yu et al in The American Journal of Pathology. Background Hepatocellular carcinoma is...
As reported in the Journal of Clinical Oncology by Sangro et al, patient-reported outcome (PRO) analysis in the phase III HIMALAYA trial showed that tremelimumab/durvalumab and durvalumab produced better outcomes than sorafenib in patients with unresectable hepatocellular carcinoma (HCC). The trial ...
On May 16, the U.S. Food and Drug Administration (FDA) announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated patients with unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other...
Gallbladder cancer rates have been stable or declining for most Americans over the past two decades, but cases have steadily risen among Black Americans, with growing numbers of cases not being diagnosed until later disease stages, according to a study presented at Digestive Disease Week 2024...
As reported in the Journal of Clinical Oncology by Cannon et al, findings in a cohort of the phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket study showed that the combination of pertuzumab and trastuzumab was active in patients with advanced biliary tract cancer with...
On October 31, 2023, pembrolizumab (Keytruda) was approved for use with gemcitabine/cisplatin in first-line treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on the double-blind KEYNOTE-966 trial...
As reported in The Lancet Oncology by Howard A. Burris III, MD, FACP, FASCO, and colleagues, a patient-reported outcome (PRO) analysis from the phase III TOPAZ-1 trial showed no “detrimental effect” with the addition of durvalumab to gemcitabine/cisplatin in patients with advanced biliary tract...
In a phase III study (ORANGE II PLUS) reported in the Journal of Clinical Oncology, Fichtinger et al found that among patients with indications for hemihepatectomy suitable for both laparoscopic and open approaches, of whom the majority had cancer, the laparoscopic approach was associated with a...
Adding the phosphatidylserine-targeting antibody bavituximab to the immunotherapy agent pembrolizumab may improve response rates without compromising safety in patients with hepatocellular carcinoma, according to a recent study published by Hsieh et al in Nature Communications. The findings...
Adding a personalized antitumor vaccine to the PD-1 inhibitor pembrolizumab may be safe and about twice as effective at shrinking tumors in patients with hepatocellular carcinoma compared with pembrolizumab alone, according to new findings presented by Yarchoan et al at the American Association for ...
Patients with unresectable hepatocellular carcinoma derived significant benefit from the addition of the monoclonal antibody durvalumab and the angiogenesis inhibitor bevacizumab to transarterial chemoembolization (TACE), which alone has been a standard of care for 20 years. Investigators of the...
Milind M. Javle, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II results on tinengotinib, a next-generation FGFR inhibitor that seems to overcome acquired resistance and shows efficacy in patients with cholangiocarcinoma with other FGFR alterations who are not eligible for FGFR2-targeted treatments. A phase III global study is currently enrolling to further evaluate the efficacy and safety of this agent vs physician’s choice in FGFR-altered, chemotherapy- and FGFR-inhibitor–refractory or relapsed disease.
Riccardo Lencioni, MD, of the University of Pisa School of Medicine, discusses phase III results from the EMERALD-1 study of durvalumab plus bevacizumab plus TACE (transarterial chemoembolization) in patients with embolization-eligible unresectable hepatocellular carcinoma. Compared with TACE alone, this combination is the first immune checkpoint inhibitor–based regimen to improve progression-free survival and has the potential to set a new standard of care in this disease, according to Dr. Lencioni (Abstract LBA432).
The addition of durvalumab and bevacizumab to transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with unresectable hepatocellular carcinoma who were eligible for embolization. According to the study authors, this is the first trial to demonstrate...
In a retrospective cohort study reported in the Journal of Clinical Oncology, Daniel Q. Huang, MBBS, and colleagues found that the use of antiviral therapy was associated with improved overall survival among patients with hepatitis B virus (HBV)- or hepatitis C virus (HCV)-related hepatocellular...