Despite Opdivo’s success in combination trials, Bristol Myers Squibb faces a challenge when Opdivo’s EU and US patents expire in 2026 and 2028 respectively, threatening sales growth. Credit: Dennis Diatel via ShutterStock.

Bristol Myers Squibb (BMS) has announced that the Phase III CheckMate-8HW trial investigating Opdivo (nivolumab) with Yervoy (ipilimumab) to treat metastatic colorectal cancer has met one of its co-primary endpoints at a scheduled interim analysis.  

The randomised, open-label CheckMate-8HW trial (NCT04008030), which enrolled 974 subjects, evaluated Opdivo plus Yervoy compared to Opdivo alone, or chemotherapy, in patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. 

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The co-primary endpoint of statistically significant improvement in progression-free survival (PFS) for the combination compared to chemotherapy in the first-line setting was met. The trial will also assess the PFS with the combination versus Opdivo alone across different treatment lines.  

Opdivo, a PD-1 inhibitor monoclonal antibody (mAb), first gained approval in 2015 to treat metastatic renal cell carcinoma. The drug has since received subsequent approvals for several indications including gastric cancer, B-cell Hodgkin lymphoma and hepatocellular carcinoma. 

In the announcement accompanying the trial results, BMS’s vice president and global programme lead of gastrointestinal and genitourinary cancers Dana Walker said: “These results further support the benefits of dual PD-1 and CTLA-4 inhibition and demonstrate our continued commitment to pursuing combination strategies that may help improve outcomes for patients with high unmet need.” 

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BMS is investigating Opdivo in several combination clinical trials for different indications. For example, the company reported in October that the Phase III CheckMate -67T trial of subcutaneous Opdivi for advanced or metastatic clear cell renal cell carcinoma (ccRCC) met its co-primary endpoints.  

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Merck’s Keytruda (pembrolizumab) is one of BMS’s main competitors, with the PD-1 inhibitor generating $21bn in sales last year, as per Merck (MSD)’s 2022 financial results. GlobalData’s patient-based forecast predicts that Opdivo will face a drastic drop in total annual sales from $8.7bn in 2028 to $85m in 2030, as it faces patent expiry in 2026 in the EU and 2028 in the US, threatening the drug’s sales growth. Keytruda’s patent runs out in 2028, but the drug is expected to maintain higher sales due to its first-to-market advantage.  

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