Saturday, October 7, 2023

Catch-Up / Power-Alley: This Week, Keynote 123 Posted A [Secondary Endpoint] Win, In Muscle-Invasive Urothelial Carcinoma...

I was detained elsewhere that day, but on Thursday, Merck got more encouraging pembrolizumab news.

Its Keynote 123 study, or "Ambassador" as it has been re-dubbed (are we trademarking study names, now?). . . show nice progression free survival durations for Keytruda. Here's the story, as reported in BioSpace:

. . .Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma.

Details of the study were limited but Merck said that at a pre-specified interim analysis review Keytruda treatment led to a statistically significant and clinically meaningful improvement in disease-free survival compared with simple observation. AMBASSADOR is ongoing and will continue to assess the effects of Keytruda on overall survival (OS), the study’s second primary endpoint. . . .

AMBASSADOR, also known as KEYNOTE-123, is a randomized and open-label study enrolling approximately 740 patients with localized muscle-invasive or locally advanced urothelial carcinoma. Pembrolizumab was administered intravenously for up to 18 cycles, while comparators in the observation arm were given no intervention beyond routine clinical procedures including a CT scan, blood analysis and an MRI.

However, Merck’s blockbuster asset has not been without its recent setbacks. Late last month, Keytruda stumbled in two Phase III studies in non-small cell lung cancer when given with Eisai’s Lenvima (lenvatinib). In this indication, the combination regimen failed to significantly boost PFS and OS when given as either a first-line or second-line intervention. . . .


Now you know -- and go Buffs, win in the heat down at ASU, tonight (I'll be peeking in on the score from the Lyric, at intermission). Smile. . . .

नमस्ते

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