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