More than 50% of patients with previously untreated advanced or metastatic renal cell carcinoma were alive at 42 months after being treated with Opdivo plus Yervoy.
The combination use of Opdivo (nivolumab) plus Yervoy (ipilimumab) showed superior responses to treatment, compared with Sutent (sunitinib), in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC), according to updated results from the phase 3 CheckMate-214 study.
These results, which were presented on at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium, held in San Francisco from Feb. 13-15, represent the longest follow-up with any immuno-oncology—based therapy in this setting.
“Results from this 42-month follow-up from the CheckMate -214 study reinforce the previously observed findings and add to the growing body of evidence suggesting that nivolumab plus ipilimumab has the potential to significantly improve long-term survival for patients with advanced renal cell carcinoma, a population with high unmet needs,” study investigator Dr. Nizar M. Tannir, from the department of genitourinary medical oncology in the division of cancer medicine at The University of Texas MD Anderson Cancer Center, said in a press release.
“Particularly noteworthy is that a consistently higher proportion of patients treated with the combination of nivolumab plus ipilimumab achieved a complete response and the majority of these complete responses were durable,” he added.
In the randomized, open-label CheckMate-214 trial, the researchers evaluated the combination regimen compared with Sutent in patients with previously untreated advanced or metastatic RCC.
In the combination arm, patients received 3 mg/kg of Opdivo plus 1 mg/kg of Yervoy every three weeks for four doses, followed by 3 mg/kg of Opdivo ever two weeks. In the other arm, patients received 50 mg of Sutent once daily for four weeks, followed by two weeks off before they continued treatment. All patients were treated until progression or unacceptable toxicity.
Overall survival, progression-free survival (the time from treatment to disease progression or worsening) and objective response rate in an intermediate to poor-risk patient population served as the endpoints of the study.
With a minimum follow-up of 42 months, patients in the intermediate- and poor-risk group who were treated with the combination regimen demonstrated a superior overall survival (52% versus 39%, respectively) and objective response rate (42% versus 26%), compared with Sutent alone. Moreover, median duration of response was not reached with Opdivo plus Yervoy, compared with 19.7 months with Sutent. Per an independent review, 10% of patients treated with the combination experienced a complete response, while only 1% of those treated with Sutent did.
Patients in the intent-to-treat population experienced similar superior outcomes with the combination regimen, compared with Sutent, including overall survival (56% versus 47%), objective response rate (39% versus 33%), duration of response (not reached to 24.8 months) and complete responses (11% versus 2%).
Complete response rates, per independent review, for patients treated with Opdivo plus Yervoy were maintained and ongoing in over 80% of patients.
The safety profile of the combination regimen was consistent with previous findings and no new safety signals or drug-related deaths occurred with extended follow-up.
“These positive findings from CheckMate-214 continue to demonstrate the complementary nature of dual immuno-therapy and reinforce the depth and durability of response the combination of Opdivo plus Yervoy can deliver for patients,” said Brian Lamon, development lead of genitourinary cancers at Bristol-Myers Squibb, said in the release. “We look forward to continuing to explore the potential that this combination holds for patients with difficult-to-treat cancers.”