BMS Cancer Immunotherapies Opdivo and Yervoy Face Setback in Phase III Trial

BMS Cancer Immunotherapies Opdivo and Yervoy Face Setback in Phase III Trial

Felipe Torres
2 min read

Bristol Myers Squibb’s Opdivo and Yervoy Combination Therapy Falls Short in Lung Cancer Trial

In a setback for Bristol Myers Squibb's (BMS) cancer immunotherapies, a Phase III trial testing the combination of Opdivo and Yervoy in patients with advanced lung cancer did not meet its primary endpoint of improving progression-free survival when used alongside chemoradiotherapy. The trial, which included 925 participants, compared BMS's combination therapy with AstraZeneca’s Imfinzi and chemoradiation therapy. Despite the disappointing results, Bristol Myers Squibb is exploring additional indications for Opdivo and Yervoy, including positive outcomes in trials for metastatic colorectal cancer and a subcutaneous version of Opdivo for advanced or metastatic clear cell renal cell carcinoma.

Key Takeaways

  • Bristol Myers Squibb's Opdivo and Yervoy combination therapy failed to meet the primary endpoint in a Phase III trial for unresectable, advanced lung cancer.
  • The trial compared Opdivo and Yervoy combination therapy with chemoradiation against AstraZeneca’s Imfinzi and chemoradiation therapy.
  • Despite generating $9 billion and $2.2 billion in sales respectively last year, Opdivo and Yervoy did not show improved progression-free survival in the trial.
  • Bristol Myers Squibb is evaluating Opdivo in multiple indications to expand approval for the drugs.


Bristol Myers Squibb's setback in the Phase III trial for Opdivo and Yervoy may have profound implications for their oncology portfolio and sales, given that the two drugs collectively generated $11 billion in 2023. This outcome could potentially impact investor sentiment and BMS's market value. Additionally, AstraZeneca stands to benefit from BMS's setback, as their drug Imfinzi competes in the same market. The competitive landscape in cancer immunotherapy is likely to intensify, fostering further research and development efforts. In response to this setback, BMS may prioritize alternative indications for Opdivo and Yervoy, such as colorectal cancer and metastatic clear cell renal cell carcinoma, to mitigate the impact. Looking ahead, this setback could prompt BMS to explore new combinations or therapies to fortify their oncology portfolio in the long term.

Did You Know?

  • Phase III trial: This is the final stage of testing before a drug or treatment can be approved by regulatory agencies like the U.S. Food and Drug Administration (FDA). It involves a comprehensive assessment of the safety and efficacy of the treatment in a large group of individuals.
  • Opdivo and Yervoy: These cancer immunotherapies, developed and marketed by Bristol Myers Squibb, work by leveraging the body's immune system to combat cancer cells. Opdivo blocks the PD-1 receptor on T-cells, while Yervoy interferes with the CTLA-4 receptor on T-cells.
  • Progression-free survival (PFS): This measure indicates the period during which a patient's disease does not progress. In the context of cancer clinical trials, it is a crucial indicator of treatment effectiveness.

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