Further follow up of the CheckMate-214 trial continues to show the superior long-term outcomes of Opdivo and Yervoy in treatment of patients with advanced renal cell carcinoma.
The combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) continues to show a superior overall survival and objective response rate compared to Sutnet (sunitinib) in high-risk patients with advanced renal cell carcinoma (RCC), according to long-term follow-up of patients in the phase 3 CheckMate-214 trial.
At the minimum follow-up of 42 months, the median overall survival of patients was 47 months vs. 26.6 months in patients with advanced RCC treated with Opdivo and Yervoy compared to those treated with Sutnet. The overall objective response rate (ORR), the proportion of patients with a tumor size reduction over a pre-specified amount of time, for those treated with the combination was 42% compared to 26% on Sutnet. Moreover, the complete response rate, the proportion of patients with no detectable cancer, in patients receiving Opdivo and Yervoy was 10% compared to 1% on Sutnet.
“I’m confident that patients who achieve a (complete response), regardless of risk category, have a high likelihood of experiencing long-term remission and potential cure,” said the lead study author, Dr. Nizar M. Tannir, in an interview with OncLive®, a sister publication to CURE®. “The combination of (Opdivo) and (Yervoy) is really the regimen of choice for the first-line treatment of patients with advanced RCC.”
As previously reported, the initial results of this trial presented at American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium, held in San Francisco from Feb. 13-15, represented the longest follow-up with any immuno-oncology-based therapy in the advanced RCC setting. Furthermore, the follow up findings were consistent with previous findings that held Opdivo and Yervoy was superior to Sutnet for patients with advanced RCC, according to Tanir.
“The ORRs in patients with intermediate- and poor-risk disease who received the combination were consistent with prior reports,” explained Tanir, from the department of genitourinary medical oncology in the division of cancer medicine at The University of Texas MD Anderson Cancer Center. “[Those responses] were in the order of 42% vs. 26% to 27% with sunitinib. In the ITT population, these rates were 39% and 33%, respectively.”
According to the follow up data, there was no new concerning data regarding safety of the treatment and most of the notable and common side effects associated with the Opdivo and Yervoy combination occurred in the first 6 months of enrollment in the trial, explained Tanir. Furthermore, the rate of grade 3 and 4 side effects was lower in the combination arm compared to Sutnet alone. However, there were eight deaths in the combination arm and four deaths in the Sutnet arm, which amounted to a 1.5% fatality rate and 4.7% fatality rate respectively.
“At the end of the day, patients would like to be cured, or at least have a durable response. A durable CR is the path to cure,” said Tanir. “Fifty-nine patients with intermediate- and poor-risk disease who received nivolumab/ipilimumab [in the CheckMate-214 trial] achieved a CR, which was just above 10%. These CRs were seen across all risk categories.”