Bristol Myers Squibb's (NYSE:BMY) late-stage study of Opdivo plus Yervoy as a first-line therapy, did not meet the main goal of overall survival (OS) in certain patients with bladder cancer.
The phase 3 trial called CheckMate -901 evaluated the company's cancer drugs Opdivo (nivolumab) plus Yervoy (ipilimumab) to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma whose tumor cells express PD-L1 ≥1%.
In the final analysis the combo therapy did not meet the main goal of OS in these patients. The company added that no new safety signals were seen at the time of the analysis.
The pharma giant said that a Data Monitoring Committee recommended that the trial continue to assess other main and secondary goals.
"Opdivo plus Yervoy has demonstrated durable, long-term survival improvements in several challenging-to-treat advanced cancers, and we are disappointed that the final analysis of CheckMate -901 did not show this same benefit in urothelial carcinoma patients whose tumor cells express PD-L1 ≥1%," said Dana Walker, vice president, development program lead, genitourinary cancers, Bristol Myers (BMY).
The study is also is also evaluating Opdivo plus Yervoy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy.
In addition, a sub-study of CheckMate -901 is evaluating Opdivo in combination with chemotherapy versus chemotherapy alone in patients who are eligible for cisplatin-based chemotherapy.
BMY -0.24% to $75.62 premarket May 16