BMS Racks Up Phase III Win in Liver Cancer Targeted by AstraZeneca and Roche

20 Mar 2024
Phase 3Drug ApprovalClinical ResultImmunotherapy
Pictured: A Bristol Myers Squibb office building/iStock, hapabapa Bristol Myers Squibb added to its tally of late-phase immuno-oncology wins Wednesday, revealing that combining Opdivo (nivolumab) and Yervoy (ipilimumab) improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche. BMS’ CheckMate -9DW trial randomized more than 700 people with untreated advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, to receive the PD-1 and CTLA-4 checkpoint inhibitors Opdivo and Yervoy or the investigator’s choice of sorafenib or lenvatinib. People on the BMS combination were living longer at an interim analysis, causing the study to hit its primary overall survival (OS) endpoint. The company is yet to share data from the study, only revealing that the effect on OS was “significant and clinically meaningful.” BMS added that the safety pro consistent with previously reported results and that adverse events were manageable with established protocols. No new safety signals were seen. BMS, which is still evaluating the readout, plans to share more data at an upcoming medical conference and discuss the results with health authorities. If BMS files for and wins approval, it would emerge as a rival to AstraZeneca and Roche for the first-line liver cancer market. CheckMate -9DW used the kinase inhibitors sorafenib and lenvatinib as comparator drugs. Bayer brought sorafenib to market as Nexavar and Eisai sells lenvatinib as Lenvima. When BMS began the Phase III trial in 2019, sorafenib was the standard of care but immunotherapy-based combinations have beaten the kinase inhibitor in recent years. The FDA approved the combination of Roche’s checkpoint inhibitor Tecentriq (atezolizumab) and VEGF inhibitor avastin (bevacizumab) in the population in 2020. Two years later, AstraZeneca won approval for Imjudo (tremelimumab) with Imfinzi (durvalumab). Imjudo and Imfinzi are, respectively, AstraZeneca’s equivalents of BMSYervoy and Opdivo. AstraZeneca and Roche won the FDA approvals by showing their combinations improved OS compared to sorafenib. Roche reported median OS of 19.2 months and 13.4 months, respectively, in its investigational and control cohorts. The OS figures in the AstraZeneca trial were 16.4 months and 13.8 months. Those results provide a benchmark for when BMS shares the OS data from its study. BMS grew Opdivo sales by 12% in the U.S. in the fourth quarter of 2023 but, with the product set to lose patent protection in 2028, the company is already looking for its next growth drivers. The drugmaker is planning to offset the impact of biosimilars by switching patients to a subcutaneous formulation of Opdivo and has a successor in development in indications including HCC. The successor, Opdualag (nivolumab and relatlimab-rmbw), is a fixed-dose combination of BMSPD-1 checkpoint inhibitor and a LAG-3-blocking antibody. BMS is testing the therapy, which the FDA approved in melanoma in 2022, as a first-line treatment for HCC and expects to report data this year. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.
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