Bristol-Myers Squibb (BMY) Announces Opdivo Plus Low-Dose Yervoy Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic RCC
Bristol-Myers Squibb Company (NYSE: BMY) today announced new results from the Phase 3 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 results from this 30-month follow-up from the CheckMate -214 study are meaningful as they continue to demonstrate that in patients with advanced renal cell carcinoma, a population with considerable unmet treatment needs, there is potential for long-term survival benefits with the combination of nivolumab and ipilimumab,” said CheckMate -214 investigator Nizar M. Tannir, M.D., FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.
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.
“We are pleased that the results from CheckMate -214 continue to provide clinical evidence that combining Opdivo and Yervoy can extend survival for certain patients with advanced renal cell carcinoma,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “These follow-up data reinforce our scientific approach and ongoing commitment to delivering treatment options that help patients living with this relentless disease live longer.”