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.
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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.