Opdivo + Yervoy success in CheckMate 650 trial for prostate cancer. -BMS

Bristol-Myers Squibb Company announced data evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Results from an interim analysis of the Phase II CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy and who had not received chemotherapy (cohort 1), with a median follow-up of 11.9 months, the objective response rate (ORR) was 25%. Additionally, among 30 patients whose disease progressed after taxane-based chemotherapy (cohort 2), with a median follow-up of 13.5 months, the ORR was 10%.

Across both cohorts, higher response rates were seen in certain patient sub-groups, including patients with high (above median) tumor mutational burden and patients with homologous recombination deficiency. The overall safety profile was consistent with prior studies of Opdivo in combination with Yervoy with this dosing schedule. Grade three to five treatment-related adverse events occurred in 42% of patients in cohort 1 and 53% of patients in cohort 2.

�The results from CheckMate -650 provide strong rationale for the development of combination immune checkpoint therapy for the treatment of prostate cancer, which is considered a cold tumor with few tumor-infiltrating lymphocytes,� said Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at The University of Texas MD Anderson Cancer Center. �The clinical results from this study are encouraging and provide the foundation to test the combination strategy in a larger cohort of patients.� The data were featured in an oral session (Abstract #142) at the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium in San Francisco.