Study: Immunotherapy Results in Longer Treatment-Free Survival Than Targeted Therapy in Patients With Renal Cell Carcinoma

Patients with advanced renal cell carcinoma who were given the combination of nivolumab and ipilimumab demonstrated a significantly longer overall survival than those who received sunitinib.

The combination therapy of nivolumab plus ipilimumab resulted in longer treatment-free survival (TFS) over a 42-month period compared to the targeted therapy sunitinib in patients with renal cell carcinoma (RCC), according to a study published in Clinical Cancer Research. These results were not dependent on which Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group these patients belonged.

“One of the great challenges in conducting clinical trials is that some of the endpoints we’ve been using to measure the efficacy and value of a treatment are not optimal, especially when evaluating immuno-oncology-based therapy regimens,” said Meredith Regan, ScD, associate professor at Harvard Medical School and Dana-Farber Cancer Institute, in a press release. “As we continue to develop new treatments, we have an opportunity to think about new methods to better balance the efficacy and toxicity to the patients. To do that, we needed a new endpoint to quantify those two aspects together—to continue to improve survival for patients while also focusing on how they are spending their time. That’s how TFS came to be.”

To conduct the study, the investigators evaluated TFS—defined as the time between ending the protocol-assigned therapy and starting a subsequent therapy or death—in the CheckMate-214 phase 3 trial. In this trial, patients receiving their first therapy for advanced RCC who were given the combination immunotherapy of nivolumab and ipilimumab demonstrated a significantly longer overall survival than those who received sunitinib. At 42 months following the start of therapy, 52% of patients receiving the combination therapy were alive compared to 39% of patients given sunitinib.

According to the investigators, the mean TFS was more than twice as long following treatment with the combination therapy compared to sunitinib for patients in the intermediate/poor risk group as determined by the IMDC. TFS was 3 times as long for patients who received nivolumab and ipilimumab in the favorable risk group compared to those who received sunitinib. Further, at 42 months, 20% of patients treated with nivolumab and ipilimumab were treatment-free, compared to 9% of patients who had received sunitinib.

“We knew from the previous CheckMate-214 analysis that nivolumab plus ipilimumab improved survival compared with sunitinib; now, we are able to compare the way patients spent that overall survival time on these two different treatment approaches, and I think having this information is an important complement to the original trial results,” Regan said in the release.


Immunotherapy may yield longer treatment-free survival than targeted therapy in advanced renal cell carcinoma patients [news release]. EurekAlert; November 10, 2021. Accessed November 15, 2021.

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