NEW YORK – Bristol Myers Squibb said on Monday that the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) failed to statistically significantly improve overall survival compared to chemotherapy as a first-line option for PD-L1-positive advanced urothelial cancer patients in the CheckMate-901 trial.
In the Phase III trial, BMS randomized 707 patients with PD-L1-positive unresectable or metastatic urothelial carcinoma. The study's primary endpoint was overall survival in bladder cancer patients with PD-L1 expression in at least 1 percent of tumor cells, but the Opdivo-Yervoy combination did not significantly extend the lives of patients in this subgroup compared to those on chemotherapy.
Dana Walker, VP and development program lead for genitourinary cancers at BMS, said in a statement that metastatic urothelial cancer is still a difficult cancer to treat and has limited therapy options. "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 greater than or equal to 1 percent," Walker said.
An independent data monitoring committee has recommended the trial continue to assess other endpoints, including overall survival in cisplatin-ineligible patients and progression-free survival in cisplatin-ineligible patients, PD-L1-positive patients, and all randomized patients.
BMS will also continue to explore other Opdivo combinations in CheckMate-901. One sub-study of the trial is evaluating Opdivo plus chemo versus chemo alone in urothelial carcinoma patients who are eligible for cisplatin-based chemotherapy. Another arm is studying the Opdivo-Yervoy combination versus chemo in bladder cancer patients who are ineligible for cisplatin-based chemotherapy.
Opdivo is already approved in the US as a later-line metastatic bladder cancer treatment and as an adjuvant therapy for those at high risk of recurrence after surgery.
In February, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Opdivo plus chemotherapy as an adjuvant treatment for muscle-invasive urothelial cancer patients with tumor cell PD-L1 expression of at least 1 percent.