Bristol Myers Squibb Trial for Opdivo Hits Primary Endpoint

Bristol Myers Squibb Co. said Monday results from the Phase 3 trial in which adjuvant treatment with Opdivo nivolumab showed a statistically significant and clinically meaningful improvement in disease-free survival, the trial’s primary endpoint, in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and tumor resection.

The pharmaceutical company said these results signify the first time an adjuvant therapeutic option has significantly prolonged disease-free survival for patients in this setting.

Bristol Myers said Opdivo was well tolerated with an acceptable safety profile relative to placebo. The majority of patients in the Opdivo arm were able to receive a relative dose intensity of more than 90%. The incidence of any treatment-related adverse events was 71% among patients treated with Opdivo compared to 46% among patients receiving placebo.

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