FDA Approval Insights: Durvalumab Plus Gemcitabine and Cisplatin in Biliary Tract Cancer

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Do-Youn Oh, MD, PhD, a professor in the Department of Medical Oncology at Seoul National University College of Medicine, about the FDA approval of durvalumab (Imfinzi) plus gemcitabine and cisplatin in patients with biliary tract cancer.

On September 2, 2022, the FDA approved the combination for adult patients with locally advanced or metastatic biliary tract cancers. The regulatory decision was based on findings from the phase 3 TOPAZ-1 trial (NCT03875235), in which the durvalumab and chemotherapy regimen improved median overall (OS) survival vs chemotherapy alone. Previously, no new advances in biliary tract cancer treatment had been made since the FDA approval of gemcitabine plus cisplatin in 2010 based on the results of the phase 3 ABC-02 trial (NCT00262769).

In TOPAZ-1, durvalumab plus chemotherapy resulted in a median OS of 12.8 months vs 11.5 months with chemotherapy alone. Additionally, the immunotherapy combination elicited a median progression-free survival of 7.2 months vs 5.7 months with gemcitabine plus cisplatin alone.

In our exclusive interview, Dr Oh discussed the significance of this approval as the first therapeutic development in biliary tract cancer in over a decade, the tolerability of the durvalumab regimen, and the importance of using immunotherapy to treat this disease.

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