Opdivo, Yervoy Combination Approved for Certain Colorectal Cancers

Drug manufacturer Bristol-Myers Squibb announced Wednesday that the FDA has approved the combination nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following a fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy treatment.

The approved indication was based on data from the ongoing phase 2 CheckMate-142 study. Within the study, the nivolumab plus ipilimumab arm enrolled MSI-H/dMMR mCRC patients who had received at least 1 prior line of therapy for metastatic disease. The efficacy of the combination treatment was evaluated for both patients who had received prior treatment (82 of the total 119 patients enrolled) as well as patients who had not received prior treatment.

Among the 82 patients who had received prior treatment, 46% (95% CI: 35-58; n = 38) responded to the combination treatment as measured by the Independent Radiographic Review Committee (IRRC). Across all enrolled patients, 49% (95% CI: 39-58; n = 58) responded to the combination treatment; 4.2% (n = 5) achieved complete response, while 45% (n = 53) experienced partial response.

Additionally, duration of response (DOR) for the 82 previously treated patients was not reached (range: 1.9-23.2+ months) 89% of this cohort of patients had responses 6 months or longer, and 21% had responses of 12 months or longer. Among all enrolled patients, duration of response was also not achieved; 83% of patients had responses 6 months or longer, and 19% had responses of 12 months or longer.

“Bristol-Myers Squibb is pleased to bring forward Opdivo plus Yervoy as the first [immuno-oncology/ immuno-oncology] combination therapy to be approved in this type of colorectal cancer,” said Ian Waxman, MD, development lead, gastrointestinal cancers at Bristol-Myers Squibb in a statement. “Our commitment to studying Opdivo plus Yervoy, which target distinct but complementary immune pathways, results from our strong believe that rational combinations in biomarker-selected populations may improve clinical benefit for patients.”

The approval for this indication was granted under the accelerated approval pathway based on overall response rate and duration of response. However, continued approval for this indication may be “contingent upon verification and description of clinical benefit in confirmatory trials.”