Keytruda hits survival targets in first-line kidney cancer

Merck & Co could steal the thunder of its German namesake Merck KGaA after reporting strong survival data for Keytruda in front-line renal cell carcinoma, the most common form of kidney cancer.

The US drugmaker – known as MSD outside North America – has just unveiled the results of its phase 3 KEYNOTE-426 trial of PD-1 inhibitor Keytruda (pembrolizumab) in combination with Pfizer’s VEGF-targeting Inlyta (axitinib), showing that the duo improved overall survival (OS) and progression-free survival (PFS) compared to Pfizer’s Sutent (sunitinib).

MSD says Keytruda is the first anti-PD-1 drug to improve both OS and PFS in first-line RCC, and that throws down a gauntlet to Merck and its partner Pfizer when it presents the JAVELIN Renal 101 study of its PD-1 drug Bavencio (avelumab) plus Inlyta in this cancer at the ESMO cancer conference this coming weekend.

Merck said in September that its trial met the PFS objective in the trial, which compares Bavencio and Inlyta to Inlyta alone, so all eyes will be on the ESMO presentation to see if it can also hit the OS endpoint.

In addition to “statistically significant and clinically meaningful” improvements on both survival measures, Keytruda plus Inlyta also achieved a higher overall response rate (ORR) compared to Sutent monotherapy, according to MSD, which said the improvements were “consistent regardless of PD-L1 expression and across all risk groups.”

Keytruda will now be filed for approval as a first-line RCC therapy alongside Inlyta, with the hope of providing a new treatment option for a patient group with poor prospects despite new targeted and immuno-oncology drugs. Fewer than 10% of people diagnosed with advanced RCC survive for five years, said MSD’s head of R&D Roger Perlmutter. “There is significant need for improved therapies for this disease,” he added.

Bristol-Myers Squibb’s cancer immunotherapy pairing of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) was approved earlier this year as first-line treatment for RCC, but only in intermediate- and poor-risk patients. According to some oncologists this should now be considered the standard regimen for previously-untreated patients, so both the Keytruda and Bavencio trials are no longer using the correct control arm.

BMS is hoping to extend Opdivo’s use in first-line RCC via the TITAN study – looking at different regimens of Opdivo and Yervoy – and Roche is also eyeing the category with its IMmotion 151 study comparing PD-L1 inhibitor Tecentriq (atezolizumab) plus Avastin (bevacizumab) to Sutent, which showed positive effects on PFS at this year’s ASCO meeting.