Updated positive results for phase III CHECKMATE 214 study of Opdivo + Yervoy versus sunitinib to treat metastatic renal cell carcinoma. - BMS

-Bristol-Myers Squibb Company announced updated results from the Phase III CheckMate -214 study evaluating the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). With a minimum follow-up of 42 months, the combination of Opdivo plus Yervoy continues to show superior overall survival (OS), objective response rates (ORR), duration of response (DOR) and complete response (CR) rates. The safety profile for Opdivo plus Yervoy was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up. The data will be featured in an oral presentation (Abstract #609) on Saturday, February 15, 2020 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco. A significant OS benefit was observed in both patients from the intermediate- and poor-risk (IP) and the intent-to-treat (ITT, i.e. all randomized) populations treated with Opdivo plus Yervoy compared to those treated with sunitinib alone. Of the patients treated with Opdivo plus Yervoy who experienced a complete response, per independent review, that response was ongoing in 84% and 86% of patients in the IP and ITT populations, respectively. In the IP populations, patients treated with Opdivo plus Yervoy demonstrated significantly improved : OS: At 42 months, the OS rate was 52% for patients treated with Opdivo plus Yervoy and 39% for patients treated with sunitinib alone [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.55-0.80)]. ORR: Per independent review, ORR was 42% with Opdivo plus Yervoy and 26% for sunitinib (p=0.0001). DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 19.7 months (95% CI: 16.4-26.4) for patients treated with sunitinib. CR: Per independent review, 10% of patients treated with Opdivo plus Yervoy experienced a CR compared to 1% with sunitinib alone. Results were similar for the ITT population, where patients treated with Opdivo plus Yervoy experienced significantly improved : OS: At 42 months, the OS rate for the ITT population was 56% for patients treated with Opdivo plus Yervoy and 47% for patients treated with sunitinib alone [HR 0.72 (95% CI: 0.61-0.86)]. ORR: Per independent review, ORR was 39% with Opdivo plus Yervoy and 33% for sunitinib (p=0.02). DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 24.8 months (95% CI: 19.4-27.3) for patients treated with sunitinib. CR: Per independent review, 11% of patients treated with Opdivo plus Yervoy experienced a CR compared to 2% with sunitinib alone. “Results from this 42-month follow-up from the CheckMate -214 study reinforce the previously observed findings and add to the growing body of evidence suggesting that nivolumab plus ipilimumab has the potential to significantly improve long-term survival for patients with advanced renal cell carcinoma, a population with high unmet needs,” said CheckMate -214 investigator Nizar M. Tannir, MD, FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “Particularly noteworthy is that a consistently higher proportion of patients treated with the combination of nivolumab plus ipilimumab achieved a complete response and the majority of these complete responses were durable.”.