Yet again Lenvima fails to Leap

Merck & Co has made much of combining Keytruda with Eisai’s Lenvima in front-line kidney cancer, but moving the combo beyond this approved use has proved impossible. Today saw two more Keytruda plus Lenvima trials flunk, both in lung cancer, taking the litany of setbacks to seven failed trials of this combo in the so-called Leap programme. Merck said Leap-008, a second-line NSCLC trial, failed versus docetaxel, while the front-line Leap-006 study of a Keytruda/Lenvima/chemo triplet failed versus Keytruda plus chemo, an approved standard of care. The results must surely have been expected given the abysmal failure in 2021 of Leap-007, a front-line NSCLC trial in patients whose tumours expressed PD-L1 at ≥1%, where Keytruda recipients actually lived longer, on average, than those given the Merck drug plus Lenvima. Possible phase 3 readouts this year include Leap-001 in endometrial carcinoma, but given the precedent hopes surely can’t be high. 

Selected Keytruda + Lenvima studies

Note: *chemo-containing triplet; **also contains TACE. Source: OncologyPipeline & company announcements.