Roche may have just grabbed the first FDA nod for a checkpoint inhibitor in previously untreated liver cancer, but Merck & Co. is hoping it won’t be far behind.
Ahead of this weekend’s virtual annual meeting of the American Society of Clinical Oncology (ASCO), the New Jersey drugmaker touted results showing a combination of its immuno-oncology star Keytruda and kinase inhibitor Lenvima—a med it shares with Eisai—could spur a response in 36% of study patients.
Those who did respond saw their benefits last for a median 12.6 months, Merck said.
While the trial, called Keynote-524, is a single-arm, phase 1b study, it’s already helped the duo nab a breakthrough therapy designation from the FDA. That label, which the agency doled out in July, should help it speed through the regulatory process and, if all goes well, give Roche’s newly approved regimen a little company.
The Swiss pharma giant nabbed a go-ahead for a Tecentriq-Avastin pairing in previously untreated liver cancer this past Friday, becoming the first immuno-oncology drugmaker to step up and challenge longtime standard of care Nexavar from Bayer. While Lenvima is already cleared to treat the same patients solo, it won that approval based on non-inferiority data, while Roche’s tandem delivered a head-to-head thumping of Nexavar—along with a 27% response rate—that raised eyebrows among doctors.
“We never had anything that beat the standard of care in front-line until this regimen,” Richard Finn, M.D., lead investigator for the Tecentriq study, said ahead of the approval, adding that the nod was a “game-changer.”
Nexavar-topping results are, of course, something the Keytruda-Lenvima combo hasn’t demonstrated yet itself, but Merck and Eisai are leaning on an expanding list of studies that show their meds are effective when paired up. That includes a kidney cancer trial also unveiled at ASCO and phase 2 data presented last fall that helped the pair snag an OK in endometrial cancer.
“As data from our combination trials continue to read out, our enthusiasm for and belief in the potential of Keytruda plus Lenvima are strengthened by the growing body of evidence observed in multiple advanced cancers,” Takashi Owa, Eisai’s chief discovery officer for oncology, said in a statement.
But while the companies wait until they can debut their combo, Roche’s regimen will be snapping up share. “I think this will be taken up pretty quickly because the efficacy data is quite impressive," Finn said.