Bristol-Myers’ Opdivo approved for metastatic colorectal cancer

Bristol-Myers announced Opdivo – nivolumab – 3 mg/kg plus low-dose Yervoy – ipilimumab – 1 mg/kg injections for intravenous use received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication has been granted under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The application was granted Priority Review and Breakthrough Therapy Designation by the FDA. Among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46% responded to treatment with Opdivo + Yervoy. The percentage of these patients with a complete response was 3.7%, and the percentage of patients with a partial response was 43%. Among these 38 responders, the median DOR was not reached; 89% of those patients had responses of six months or longer, and 21% had responses of 12 months or longer. This trial is ongoing. Among all enrolled patients, 49% responded to treatment with Opdivo + Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response. Opdivo was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction. Serious adverse reactions occurred in 47% of patients. The Opdivo + Yervoy combination is also approved in two other tumor types, advanced renal cell carcinoma and unresectable or metastatic melanoma. Continued approval for these accelerated approval indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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