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