Bristol Myers Squibb's Opdivo-Yervoy Combo Approved for First-Line Liver Cancer Treatment

Bristol Myers Squibb (BMS) has secured FDA approval for its immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) in the treatment of newly diagnosed unresectable or metastatic hepatocellular carcinoma (HCC). This approval positions BMS to compete directly with established immunotherapy-based treatments from Roche and AstraZeneca in the first-line liver cancer space.

Opdivo-Yervoy Combination Shows Promising Results

The FDA's decision was based on data from the CheckMate-9DW trial, which demonstrated significant improvements in patient outcomes. Key findings include:

• A 21% reduction in the risk of death compared to standard therapies Lenvima or Nexavar
• Median survival time extended by 3.1 months to 23.7 months
• Objective response rate of 36% versus 13% for the control group
• Median duration of response more than doubled at 30.4 months compared to 12.9 months for the control

Wendy Short Bartie, BMS's senior VP of U.S. oncology commercialization, emphasized the potential for longer life offered by this immunotherapy regimen compared to traditional targeted therapies.

Competitive Landscape in First-Line Liver Cancer

The approval of Opdivo-Yervoy places BMS in direct competition with two other immuno-oncology regimens:

1. Roche's Tecentriq and Avastin: Approved in 2020, this combination reduced the risk of death by 34% versus Nexavar alone, with a median overall survival of 19.2 months.

2. AstraZeneca's Imfinzi and Imjudo: Approved in 2022, this pairing decreased the risk of death by 22% compared to Nexavar, with a median overall survival of 16.6 months.

BMS's combination is unique in its use of Lenvima as a comparator, which is considered a more potent tyrosine kinase inhibitor in first-line liver cancer treatment.

Future Outlook and Market Implications

The approval of Opdivo-Yervoy for first-line liver cancer treatment represents a significant shift in the therapeutic landscape. While the three major immunotherapy combinations have shown promising results, questions remain about their relative efficacy compared to Lenvima monotherapy.

Merck's attempt to combine Lenvima with Keytruda failed to show a statistically significant survival benefit in the phase 3 Leap-002 trial, highlighting the challenges in this treatment area.

As the market evolves, physician choice is likely to be driven by overall survival rates and long-term efficacy data. With approximately 38% of patients on the Opdivo-Yervoy combination remaining alive at three years in the CheckMate-9DW trial, compared to 24% in the control arm, BMS's offering presents a compelling option for healthcare providers and patients alike.