FDA Approval Insights: Durvalumab Plus Tremelimumab in HCC

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 Ghassan K. Abou-Alfa, MD, an attending physician at Memorial Sloan Kettering Cancer Center in New York, New York. Dr Abou-Alfa joined us to speak about the FDA approval of durvalumab (Imfinzi) plus tremelimumab (Imjudo) in hepatocellular carcinoma (HCC).

On October 24, 2022, the FDA approved the combination of durvalumab and tremelimumab for adult patients with unresectable HCC. The regulatory decision was supported by the results of the phase 3 HIMALAYA trial (NCT03298451), in which the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen elicited an overall survival (OS) of 16.43 months vs 13.77 months with sorafenib (Nexavar). The 3-year OS rates were 30.7% with the combination vs 20.2% with sorafenib.

In our exclusive interview, Dr Abou-Alfa discussed the significance of this approval, the STRIDE regimen’s unique mechanism of action, and the importance of expanding access to this combination for patients around the world.

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