BMS Achieves Phase III Success in Liver Cancer, Challenging AstraZeneca and Roche

Bristol Myers Squibb (BMS) has announced a significant milestone in the field of immuno-oncology, with the successful combination of two of its drugs, Opdivo (nivolumab) and Yervoy (ipilimumab), demonstrating enhanced overall survival rates in patients with advanced hepatocellular carcinoma (HCC), a prevalent type of liver cancer. The achievement is notable as it positions BMS to compete directly with AstraZeneca and Roche, who currently dominate the market for checkpoint inhibitors.
In the CheckMate -9DW trial, over 700 untreated HCC patients were randomly assigned to receive either the BMS checkpoint inhibitors or a selection of sorafenib or lenvatinib, the latter two being the investigator's choice. The interim analysis revealed that patients treated with the BMS drug combination experienced longer survival times, successfully meeting the study's primary endpoint for overall survival (OS).
While the specific data from the trial is yet to be disclosed, BMS has indicated that the impact on OS was both "significant" and "clinically meaningful." Furthermore, the safety profile of the combination therapy was found to be in line with previous findings, with adverse events being manageable through established protocols and no new safety concerns arising.
BMS is in the process of further evaluating the trial results and intends to present more comprehensive data at an upcoming medical conference. The company also plans to engage with health authorities regarding the findings. Should BMS proceed with regulatory submissions and secure approval, it could emerge as a formidable competitor to AstraZeneca and Roche in the first-line liver cancer treatment space.
The CheckMate -9DW trial utilized sorafenib and lenvatinib, both kinase inhibitors, as comparative treatments. Sorafenib, marketed by Bayer under the brand Nexavar, and lenvatinib, sold by Eisai as Lenvima, were the standard treatments when BMS initiated the Phase III trial in 2019. However, in recent years, immunotherapy-based combinations have surpassed the effectiveness of the kinase inhibitor.
The FDA has previously approved combinations from both Roche and AstraZeneca, with Roche's Tecentriq (atezolizumab) and avastin (bevacizumab) receiving approval in 2020, followed by AstraZeneca's Imjudo (tremelimumab) and Imfinzi (durvalumab) in 2022. These approvals were granted based on their ability to improve OS compared to sorafenib, setting a benchmark for BMS's forthcoming OS data.
Opdivo sales in the U.S. saw a 12% increase in the fourth quarter of 2023 for BMS. As the drug is set to face patent expiration in 2028, the company is actively seeking new avenues for growth. To mitigate the impact of biosimilars, BMS is transitioning patients to a subcutaneous formulation of Opdivo and is also developing a successor drug, Opdualag (nivolumab and relatlimab-rmbw), a fixed-dose combination therapy that includes a LAG-3-blocking antibody. The FDA approved Opdualag for melanoma in 2022, and BMS is currently testing it as a first-line treatment for HCC, with data expected to be released later this year.