The Food and Drug Administration has approved Opdivo  (nivolumab; Bristol-Myers Squibb) in combination with Yervoy (ipilimumab; Bristol-Myers Squibb) for the treatment of adult and pediatric patients ≥12 years old with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 

The approval was based on data from the ongoing Phase 2 CheckMate-142 study which enrolled patients with MSI-H/dMMR metastatic CRC who had received ≥1 prior line of therapy for metastatic disease (N=119). Among patients who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, 46% (N=38/82) had a response to treatment with Opdivo + Yervoy (complete response: 3.7%; partial response: 43%; median duration of response [DOR]: not reached [range 1.9-23.2+ months]). Among all enrolled patients, 49% (N=58/119) responded to the combination treatment (complete response: 4.2%; partial response: 45%; median DOR: not reached [1.9-23.2+ months]).

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“The FDA’s approval of an [immuno-oncology]/[immuno-oncology] combination provides us with an encouraging approach to address this challenging disease in patients who have progressed following treatment with 3 standard chemotherapy options,” said Heinz-Josef Lenz, MD, FACP, L. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine of University of Southern California and principal investigator of the study at USC Norris Comprehensive Cancer Center. As this indication was approved under accelerated approval based on overall response rate and DOR, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

The combination of Opdivo, a programmed death receptor-1 (PD-1) blocking antibody, and Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody is also approved for the treatment of patients with unresectable or metastatic melanoma and for those with intermediate or poor risk, previously untreated advanced renal cell carcinoma. Opdivo is also approved as a single agent for the treatment of MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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