The race is on between two Big Pharmas to snag a new indication in kidney cancer, but thanks to new data from Merck & Co., it may not matter who gets there first.
The FDA doled out priority reviews to two regimens for previously untreated patients late last week—a combination of Pfizer’s Inlyta and Merck & Co.’s immuno-oncology star Keytruda and a pairingof Inlyta and Pfizer-Merck KGaA partnered I-O drug Bavencio. Both are now expecting a sped-up decision from regulators this June.
But the way analysts see it, even if both regimens snag an OK, it won’t necessarily be much of a contest in the marketplace. After Merck & Co. rolled out new details from its phase 3 trial over the weekend, Evercore ISI analyst Umer Raffat predicted the Keytruda combo was “likely to be considered standard-of-care for first-line RCC across subpopulations” and added that it “sets a high bar for future trials in the indication.”
One big difference: For the Keytruda regimen, it didn’t matter whether patients tested positive for PD-L1, the biomarker targeted by the Merck & Co. drug and its rival checkpoint inhibitors.
In a Saturday presentation, the New Jersey pharma giant showed that PD-L1 status didn’t factor into how well the regimen worked at extending their lives. Among the 59% of patients who bore the biomarker, the Keytruda combo cut the risk of death by 46%; in the PD-L1 negative group, they slashed the death risk by 41%.
That result surprised industry watchers, as Pfizer’s Bavencio-Inlyta trial—and a trial testing Bristol-Myers Squibb’s already-approved Opdivo-Yervoy combo—“showed a major effect of PD-L1 expression on efficacy,” Raffat noted.
And as Merck has reiterated since trumpeting top-line results in October, its duo also worked consistently across risk groups—a claim Bristol-Myers can’t make.
“The fact that you have a combination with a really remarkable outcome as well as consistency of results across the spectrum of risk categories I think will be a game-changer for the field,” Scot Ebbinghaus, M.D., Merck VP of clinical research, said in a Friday interview.
Raffat isn’t the only analyst who expects to see Merck & Co. take the kidney cancer crown once it locks up an FDA go-ahead in first-line patients. Credit Suisse’s Vamil Divan predicted last week that kidney cancer would become “another indication where Merck will likely start taking share from Bristol.” And when it comes to the Bavencio-Inlyta showdown, Divan gives the Keytruda-Inlyta marriage the advantage.
“We view Keytruda + Inlyta as likely to overtake Bavencio + Inlyta as well, given greater physician comfort with Keytruda over Bavencio,” Divan wrote.
Meanwhile, Bavencio—which has struggled to rack up new indications thanks to trouble in the clinic—is already facing down Keytruda in both of its other indications. Both of the checkpoint inhibitors boast green lights in bladder cancer, and Keytruda late last year moved into Merkel cell carcinoma to battle Bavencio in its original market.
A Product Manager with expertise in pharma marketing and sales operations