Bristol-Myers Squibb has unveiled long-term results for Opdivo in renal cell carcinoma, which demonstrated efficacy with and without CTLA4 blocker Yervoy.
BMS is continuing to build the case for its checkpoint inhibitor Opdivo (nivolumab) in RCC – the most common type of kidney cancer – with updated results from two studies, as it begins to face competition in the disease area from a number of rivals.
The first set of updated results are from the CheckMate-025 study, which showed that Opdivo (nivolumab) monotherapy continued to demonstrate overall survival benefit after 64 months, with 26% of patients alive at this time-point compared to 18% of those treated only with the standard chemotherapy drug everolimus.
BMS also reported updated results from its CheckMate-214 trial, which evaluated Opdivo in combination with Yervoy (ipilimumab).
At 42 months, the combination regimen continued to demonstrate superior overall survival, objective response rates, duration of response and complete response rates.
Out of the patients treated with the Opdivo/Yervoy combination who experienced a complete response, 84% and 86% in the intermediate- and poor-risk and the randomised populations had ongoing responses, respectively.
Initial results from the CheckMate-025 study formed the basis of an FDA breakthrough designation for Opdivo in this setting, and the subsequent approval for the checkpoint inhibitor in advanced RCC.
BMS is facing increasing competition in kidney cancer, however, from the likes of other combination regimens such as Merck & Co/Pfizer’s Keytruda plus Inlyta and Pfizer/Merck KGaA’s Bavencio plus Inlyta.
Both of these combinations are approved for the treatment of RCC. The Keytruda combination, in particular, spells trouble – Keytruda is no-doubt the leading checkpoint inhibitor in terms of revenues, due in large part to its dominant use in the lucrative first-line non-small cell lung cancer indication.
Merck’s drug is also already widely prescribed by oncologists across a growing number of indications, which could help Keytruda plus Inlyta become the preferable choice in RCC too.
BMS will be hoping that this new long-term data will mark Opdivo’s place in RCC as the go-to treatment, be it with or without the addition of Yervoy.
“These data represent the longest follow-up for a PD-1 immune checkpoint inhibitor in this setting and underscore the potential increased survival rates Opdivo can deliver for patients with advanced RCC who have received prior antiangiogenic therapy,” said Robert Motzer, lead investigator of the CheckMate-025 study.