BMS immunotherapy combo boasts trial win as first-line liver cancer treatment

Clinical ResultDrug ApprovalPhase 3ImmunotherapyBiosimilar
Bristol Myers Squibb shared a first look at results from a phase 3 trial evaluating the dual immunotherapy combo of Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC) in a late-breaking oral presentation at ASCO today.
In the CheckMate -9DW trial, the Opdivo-Yervoy combo significantly improved overall survival when compared to the investigator’s choice of Eisai’s Lenvima (lenvatinib) or Bayer’s Nexavar (sorafenib). Median overall survival was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with lenvatinib or sorafenib.
HCC accounts for 90% of all liver cancers. According to BMS, it is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.
In 2020, the FDA approved Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) combo to treat advanced or unresectable HCC, making it the first and only cancer immunotherapy regimen approved for HCC at the time. In 2022, AstraZeneca won approval for its combo of CTLA-4 inhibitorCTLA-4 inhibitor Imjudo and Imfinzi (durvalumab).
The Opdivo-Yervoy combo is already established as a second-line treatment for patients with advanced HCC, so the CheckMate trial results set the combo up for use in a first-line setting. BMS said it looks forward to sharing the data with health regulators.
In 2018, an Opdivo-Yervoy combo was approved by the FDA as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced kidney cancer. In 2020, the combo was approved to treat patients with hepatocellular carcinoma, the most common type of liver cancer.
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