Nivolumab Plus Ipilimumab Shows Promising Overall Survival in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

The combination maintained superior OS and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients.

Nivolumab (Opdivo, Bristol Myers Squibb) plus ipilimumab (Yervoy, Bristol Myers Squibb) demonstrated durable, long-term survival in the phase 2 CheckMate-214 trial, with a 5-year overall survival (OS) rate of 48% in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC), according to a Bristol Myers Squibb press release.

The combination maintained superior OS and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients.

Additionally, in intermediate- and poor-risk patients, nivolumab and ipilimumab maintained treatment effects over 5 years with ongoing improvements in OS and overall response rate, which were 2 of the trial’s primary endpoints, according to the press release.

In the analysis of all randomized patients, the combination showed a median OS of 55.7 months in the intent-to-treat population—which is the longest survival outcome reported to date in a phase 3 trial in advanced RCC—versus 38.4 months with sunitinib, according to Bristol Myers Squibb.

The safety profile was manageable for the combination, and no new safety signals emerged with extended follow-up.

“The five-year data from the CheckMate -214 trial demonstrate that nearly half of patients lived longer after 5 years in this phase 3 trial for advanced renal cell carcinoma,” said CheckMate-214 investigator Robert J. Motzer, MD, in a press release. “While the median duration of response has not yet been reached with nivolumab plus ipilimumab, the data show some durable effects of this combination for patients living with this disease.”

The data over the course of 5 years, which was presented at the European Society for Medical Oncology Virtual Congress 2021 (ESMO), included conditional survival analyses and key findings, such as:

  • Patients who were alive 3 years after starting treatment with nivolumab plus sunitinib had an 81% probability of remaining alive for an additional 2 years compared to 72% with sunitinib.
  • Patients who were progression-free 3 years after starting treatment with the dual immunotherapy combination had an 89% probability of remaining progression-free for an additional 2 years, compared to 57% with sunitinib.
  • Patients who responded to treatment with the combination and remained in response for 3 years had an 89% probability of remaining in response for 2 additional years versus 63% with sunitinib.

REFERENCE

Five-Year Data from CheckMate -214 Show Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Longest Median Overall Survival Currently Reported in Phase 3 Trial of Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma. BMS. September 16, 2021. Accessed September 17, 2021. https://news.bms.com/news/corporate-financial/2021/Five-Year-Data-from-CheckMate--214-Show-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Demonstrates-Longest-Median-Overall-Survival-Currently-Reported-in-Phase-3-Trial-of-Patients-with-Previously-Untreated-Advanced-or-Metastatic-Renal-Cell-Carcinoma/default.aspx