Re-Posting, As Rahway Wins Another Keytruda® Approval In NSCLC, At FDA... As We Predicted, Last Week. [We Review Lehman -- At Bottom.]

UPDATED -- 10.16.2023: As of Monday night, the FDA had approved the below expanded authorization for pembrolizumab. Great news for Merck. End update.

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. BTW, the Lehman Trilogy is very inventive theater, well told -- and a fascinating capitalists' history of pre-Civil War Alabama, and King-Cotton -- it treated fairly both slavery and post that, the crash of 1929.

But these clever, funny lil' men lost their way in telling the tale -- after about 1960.

It seemed to me (having lived experience with the firm, and having done deals of scale -- during the early 2000s) that the Lehman heirs likely paid for a puff piece of mythology (in the form of a Broadway show), certainly by the time 2007-08 rolls around.

The first century is a tenderly told story of penniless Jewish immigrants, making good in the New World -- but just as plainly, it all but ignores how a final century of just forever focusing on "higher interest rate" returns, to the exclusion of all else. . . was the rot -- that crept into the core of Lehman Shearson American Express -- and finally. . . just Lehman Bros.

As is often true, history is determined by the one holding the pen -- at the end. And to my eye, this looks like an attempt to re-write history -- in the form of theater. Ah, well.

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