Merck increases grip on its lead in lung cancer, winning approval for Keytruda/chemo combo as first-line therapy
Merck has won its bid to advance its leadership in treating the crucial non-small cell lung cancer market, gaining an FDA approval to start marketing a combination of its PD-1 drug Keytruda with chemotherapy as a first-line therapy. And its shares immediately popped, surging 4% on the news in after-market trading while rival Bristol-Myers Squibb took another beating, sliding 2%.
Merck built its bid for an accelerated approval around Phase II data demonstrating that the chemo/checkpoint combo spurred a much higher concentration of overall responses for NSCLC than chemo alone — 55% vs. 29%, P = 0.0016. High PD-L1 expressers did even better, though the approval comes through for all patients regardless of biomarker status. Here’s the link to the new label.
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