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
Project | Pimicotinib | Vimseltinib |
---|---|---|
Company | Merck KGaA/ Abbisko | Ono (via Deciphera) |
Trial | Manuever | Motion |
Entry criteria | Previous Gleevec/Tasigna allowed | |
ORR at wk 25 | 54% vs 2% placebo | 40% vs 0% placebo |
TEAEs leading to dose reduction | 8% | 42% |
TEAEs leading to discontinuation | 2% | 6% |
Source: company releases.
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