This was widely expected, given the fine interim results Rahway earlier posted, in KEYNOTE-671.
Now we have a likely approval date, from FDA -- October 16, 2023. Again, the pembrolizumab freight train just keeps rolling on -- out, into the night. . . seemingly. . . forever. Here's the news:
. . .Merck announced today that its anti-PD-1 therapy Keytruda reached the dual primary endpoint of overall survival (OS) in a Phase 3 trial designed to test it as a neoadjuvant and adjuvant option for resectable non-small cell lung cancer (NSCLC).
In a previous interim analysis, the trial known as KEYNOTE-671 of 786 patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC met the other dual primary endpoint of event-free survival (EFS) and key secondary endpoints.
KEYNOTE-671 “represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA, or IIIB (T3-4N2) non-small cell lung cancer,” Dr. Marjorie Green, MRK’s head of late-stage oncology, said.
According to the company, Keytruda plus chemotherapy before surgery (neoadjuvant) and as a single agent after surgery (adjuvant) indicated a statistically significant and clinically meaningful improvement in OS against the comparator. . . .
Now you know -- getting to excited to see "Hamilton" again tomorrow. Grin. . . .
नमस्ते
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