Bristol-Myers Squibb Company (NYSE:BMY) today announced safety and efficacy data from a Phase 1/2 study of urelumab in combination with Opdivo (nivolumab) in patients with hematologic and solid tumors, including biomarker analyses by level of PD-L1 expression. The combination of urelumab and Opdivo showed encouraging efficacy among 46 evaluable melanoma patients with an objective response rate (ORR) of 50% (23/46 with 18 confirmed and 5 unconfirmed). ORR was a secondary endpoint as measured by Response Evaluation Criteria In Solid Tumors (RECIST). Similar response was seen in both PD-L1 positive and PD-L1 negative melanoma patients, with ORR of 50% (10/20) and 47% (8/17) in those with =1% and <1% PD-L1 expression, respectively. Among the other cohorts (n=78), one non-small cell lung cancer (NSCLC) patient and one squamous cell carcinoma of the head and neck (SCCHN) patient had an objective response. In the full patient population (n=138), no significant added toxicity was observed with urelumab in combination with Opdivo over Opdivo monotherapy. These data were presented at an oral presentation (poster number 239) at the Society for Immunotherapy of Cancer (SITC) 31 Annual Meeting on November 12 at 10:40 a.m. EST in National Harbor, Maryland. The overall rate of treatment-related adverse events (TRAEs) was 63% (n=87), with the most common being fatigue (31%), ALT increased (11%), anemia (10%), and AST increased (9%). No additional signals were seen with the combination therapy compared to Opdivo monotherapy. The rate of Grade 3-4 TRAEs was 17% (n=23). The rate of discontinuations due to TRAEs was 6% (n=8). Urelumab is a fully human monoclonal IgG4k antibody agonist of CD137, a tumor necrosis factor (TNF) family receptor expressed primarily on activated T cells and activated natural killer (NK) cells. Opdivo blocks the inhibitory function of the PD-1 receptor on T cells. "These results suggest that urelumab in combination with Opdivo may offer an antitumor benefit in patients with melanoma, in both PD-L1 expressors and non-expressors," said Erminia Massarelli, MD, PhD, MS, Associate Clinical Professor at the City of Hope Comprehensive Cancer Center. "While there have been major advances in melanoma treatment over the past five years, some patients continue to need additional options to treat the disease, which is one of deadliest forms of cancer." "We are committed to exploring complementary immune pathways and mechanisms and look forward to continued study of urelumab in combination with multiple Immuno-Oncology agents across various tumor types and personalized to patient biologies," said Tim Reilly, head of Oncology Early Assets Development at Bristol-Myers Squibb.