Benzinga - by Vandana Singh, Benzinga Editor.
Bristol Myers Squibb & Co (NYSE: BMY) released topline data from Phase 3 CheckMate -8HW trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to the investigator’s choice of chemotherapy as a first-line treatment for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer.
The study met the dual primary endpoint of progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) at a pre-specified interim analysis.
The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.
The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified.
The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints.
“The benefits of Opdivo plus Yervoy in MSI-H/dMMR mCRC were established previously in CheckMate -142, in which the dual immunotherapy combination demonstrated strong and durable anti-tumor activity among patients who had progressed after prior fluoropyrimidine-based combination chemotherapy, the company said.
Most recently, Bristol Myers announced that the FDA accepted the supplemental Biologics License Application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial.
The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act goal date of April 5, 2024.
Price Action: BMY shares are up 2.20% at $50.98 on the last check Thursday.
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