Investigator-assessed objective response rate was 54.8%, responses were durable and median duration of response was not reached
Median overall survival was not reached and overall survival rate at 9-months was 87.6% for patients receiving Opdivo plus Yervoy
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced interim data from CheckMate -142, a Phase 2, multi-cohort trial evaluating Opdivo (nivolumab) monotherapy or in combination with Yervoy (ipilimumab) for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC). These results from the Opdivo and Yervoy combination cohort of the trial included 84 patients who received their first dose at least 6 months prior to analysis. The primary endpoint of investigator-assessed objective response rate (ORR) was 54.8% (95% CI: 43.5, 65.7). Responses were sustained up to 15.9 months and 85% of responses were ongoing; median duration of response was not yet reached. The 9-month overall survival (OS) rate was 87.6% (95% CI: 78.1, 93.1) and median OS had not been reached at the time of analysis. The safety profile of the Opdivo plus Yervoy combination included 28.6% of patients with Grade 3/4 treatment-related adverse events (AEs). These data from Abstract #3531 will be presented today from 8:00–11:30 AM CDT in Hall A at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
“The clinically meaningful survival and response data for patients with dMMR or MSI-H colorectal cancer treated with Opdivo in combination with Yervoy are very promising,” said Thierry Andre, M.D., Head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris. “These interim data are important as they build on the study results observed with Opdivo monotherapy in these patients and show the potential of an Immuno-Oncology combination in this advanced type of colorectal cancer for which there is a significant unmet need.”
