No luck in three Keytruda studies

With Merck & Co's $3bn annual cost-cutting plan seizing the limelight in a first-half earnings release on Tuesday, clinical trial minutiae took a back seat. But the company quietly revealed the failure of two Keytruda phase 3 studies, Keynote-937 in adjuvant liver cancer and Leap-014 (Lenvima plus chemo triplet) in first-line oesophageal carcinoma. The former joins an earlier liver flop in the Keynote-240 trial, meant to confirm Keytruda's second-line accelerated approval, which nevertheless remains in place. Meanwhile, Leap-014's failure comes on the heels of a litany of Lenvima combo disappointments, most recently in Leap-015 in front-line HER2-positive gastroesophageal adenocarcinoma. The Lenvima combo failures include Leap-002 in first-line liver cancer; Keynote-524, an uncontrolled Keytruda/Lenvima combo in first-line liver cancer, earlier prompted a CRL. A separate trial, Keynote-F21, testing the Pfizer-partnered Padcev as monotherapy or as Keytruda combo in solid tumours, was terminated by Astellas on Wednesday, as was EV-104, a phase 1 study of intravesical Padcev in non-muscle invasive bladder cancer (NMIBC). The last setting has seen a good deal of activity, and recently unveiled ESMO titles revealed a mystery Pfizer project, PF-08052667, described as "an ADC optimised for intravesical delivery to treat NMIBC".

Selected recently disclosed trial failures

Source: OncologyPipeline.