Merck KGaA gets a rare cancer win

Merck KGaA’s oncology attempts haven’t always gone well recently, but on Tuesday the group announced a late-stage victory for pimicotinib, a CSF-1R inhibitor licensed from Abbisko last year. The problem now could be competing in tenosynovial giant cell tumour (TGCT), a small niche where Daiichi’s Turalio is already approved and Ono’s vimseltinib might soon be – that project, which Ono gained via its purchase of Deciphera, has a PDUFA date of 17 February after prevailing in the Motion trial. The 54% overall response rate seen with pimicotinib in the phase 3 Maneuver study is a far cry from the 88% reported in phase 1 with an optimal dose, but on a cross-trial basis the project looks to have an edge over vimseltinib on efficacy and safety. More details will be needed; liver enzyme and creatine phosphokinase levels, which were increased with vimseltinib in Motion, will be watched closely. Turalio, which hits KIT and FLT3 in addition to CSF-1R, is approved on a 38% ORR, but has a black box warning of hepatotoxicity. Others developing CSF-1R inhibitors for TGCT include SynOx, whose emactuzumab is in the phase 3 Tangent trial, and privately held AnMax Bio, with the Amgen-originated AMB-05X in phase 2.

Cross-trial comparison of pimicotinib vs vimseltinib in TGCT

Source: company releases.