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FDA Approval of Zanidatamab - HERIZON-BTC-01 Discussion with Dr. Shubham Pant


Key Points: 

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• Overview of biliary tract cancer and its treatment landscape
• Study design and patient characteristics from the HERIZON-BTC-01 trial
• Key findings, including overall response rates and duration of response
• The importance of HER2 testing and its implications for treatment sequencing
• Side effect profiles and management strategies for Zanidatamab 
• Future directions and ongoing clinical trials

In this episode of the Oncology Brothers podcast, Drs. Rohit and Rahul Gosain, dive into the recent FDA approval of Zanidatamab, a bispecific HER2 antibody, for HER2 amplified, unresectable, locally advanced, or metastatic biliary tract cancer. Joined by Dr. Shubham Pant, a GI medical oncologist at MD Anderson Cancer Center and one of the authors of the HERIZON-BTC-01 study that led to this approval.
We start by discussing the landscape of biliary tract cancer, which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, and the importance of identifying actionable mutations in this rare disease. Dr. Pant emphasizes the significance of HER2 as a valid target and shares insights from the study design and patient characteristics.

The key findings from the HERIZON-BTC-01 study reveal an overall response rate of 41.3% and a median duration of response of 14.9 months, which is promising compared to historical controls. We also discuss the importance of HER2 testing, particularly IHC positivity, and how it can guide treatment decisions in the community setting.
As we explore the sequencing of HER2-targeted therapies, Dr. Pant shares his thoughts on using Zanidatamab followed by TDXD, highlighting the manageable side effect profile of Xanadatamab, including diarrhea and infusion-related reactions.

Finally, we touch on the future of Zanidatamab, including ongoing trials and the need for community oncologists to test for HER2 positivity in biliary tract cancer patients. This episode underscores the exciting advancements in treatment options for this patient population and the importance of a multidisciplinary approach in managing their care.

Thank you for joining us, and we look forward to sharing more insights on recent FDA approvals and treatment algorithms in future episodes!