Data from Pharmawand - Curated by EPG Health - Date added 13 February 2019
Bristol-Myers Squibb Company announced new results from the Phase III CheckMate -214 study, showing that therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to Opdivo plus low-dose Yervoy continued to show a significant overall survival (OS) benefit compared to those randomized to sunitinib. Additionally, at 30 months, the objective response rate (ORR) per investigator for intermediate- and poor-risk patients with Opdivo plus low-dose Yervoy improved compared to the previous analysis at a minimum of 17.5 months.OS: The 30-month OS rate for the intermediate- and poor-risk population was 60% for patients treated with Opdivo plus low-dose Yervoy versus 47% for patients treated with sunitinib [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.54, 0.80); p<0.0001]. ORR: Opdivo plus low-dose Yervoy was associated with a 42% ORR versus 29% with sunitinib (p=0.0001). More than half (52%) of the intermediate- and poor-risk patients who responded to Opdivo plus low-dose Yervoy had a response lasting at least 18 months versus 28% of the patients who responded to sunitinib. Complete Response (CR): The CR rate was 11% with Opdivo plus low-dose Yervoy versus 1% with sunitinib.
The results were similar for the intention -to-treat (ITT, i.e., all randomized) population with Opdivo plus low-dose Yervoy, demonstrating significantly improved:OS: The 30-month OS rate for the ITT population was 64% for patients treated with Opdivo plus low-dose Yervoy versus 56% for patients treated with sunitinib [HR 0.71 (95% CI: 0.59, 0.86); p=0.0003]. ORR: The ORR was 41% with Opdivo plus low-dose Yervoy versus 34% for sunitinib (p=0.015).CR: The CR rate was 11% with Opdivo plus low-dose Yervoy versus 2% with sunitinib. The overall safety of the combination was consistent with that observed in the 17.5-month minimum follow-up analysis and with previously reported studies of these medicines in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up.
The data will be featured in a rapid oral presentation (Abstract #547) on Saturday, February 16, 2019 at the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium in San Francisco..0>