MUNICH—After batting aside efficacy questions in head and neck cancer, Merck’s Keytruda is back with a new batch of positive data, this time in previously untreated patients.
Monday at the European Society for Medical Oncology annual meeting, the New Jersey drugmaker trumpeted phase 3 data showing its immuno-oncology star cut the risk of death in PD-L1 positive patients by 22% when compared with a standard-of-care regimen known by doctors as “Extreme." And in patients with high levels of the PD-L1 biomarker in their tumors, that number jumped to 39%, Merck said.
The pharma giant also tested a combo of Keytruda and chemo against Extreme, finding that the duo cut the death risk by 23% regardless of patients’ PD-L1 status.
Based on “the limited interaction we’ve had with key opinion leaders, I think this is seen as practice-changing,” Roy Baynes, Merck SVP and head of global clinical development, said.
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As Merck noted when it released top-line results in July, at the interim check-in, Keytruda hadn’t shown it could delay the time to cancer progression. But the company is hoping that its survival numbers will get the job done when it comes to a new approval, which Merck intends to file for “as soon as we can,” Baynes said.
Last summer, Keytruda raised eyebrows when, after grabbing a conditional FDA approval in previously treated head and neck cancer, it failed to show it could actually extend the lives of patients in that group.
But in light of the narrow miss, the FDA stood by its green light. The move left Merck to continue battling for market share with archrival Bristol-Myers Squibb, whose Opdivo also boasts a go-ahead in previously treated patients.
Opdivo, though, doesn’t have clearance to treat patients in the first-line setting, and if Merck can bag that indication, it’ll get access to a patient population that swells by about 63,000 U.S. cases per year, it says.