Response rate over 70%! Bristol-Myers Squibb Company (BMY.US) breakthrough immune combination therapy qualifies for FDA priority review.

Bristol-Myers Squibb Company (BMY.US) announced that the US FDA has accepted a supplemental Biologics License Application (sBLA) for the blockbuster immunotherapy combination therapy Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC) in adult and pediatric (12 years and older) patients. The FDA has granted the application breakthrough therapy designation and priority review, with an expected completion of the review by June 23, 2025. A analysis released at the end of January this year showed that, with a median follow-up of 47 months, patients treated with Opdivo in combination with Yervoy had a 38% reduced risk of disease progression or death compared to Opdivo monotherapy. At 12, 24, and 36 months, the progression-free survival rates for Opdivo in combination with Yervoy were 76%, 71%, and 68%, respectively, higher than the 63%, 56%, and 51% seen with Opdivo monotherapy. In addition, the objective response rate (ORR) for Opdivo in combination with Yervoy was 71%, significantly higher than Opdivo monotherapy (58%, p=0.0011). Previous results had shown that, compared to investigator's choice chemotherapy, Opdivo in combination with Yervoy as a first-line therapy reduced the risk of disease progression or death by 79%.