pre-market reaction to the report issued this morning was initially negative. Although, the SPA for PFS was met, at the 2nd interim the DMC stated, “Although the primary endpoint, PFS, technically met the boundary for the secondary interim analysis for efficacy, the overall survival estimates are premature, limited by a 40-week median follow-up time. Therefore, it is not yet clear that overall survival is supportive. The PFS advantage of 7 weeks is not of sufficient clinically meaningful benefit, especially considering the toxicity, and is insufficient to suggest early termination for efficacy without at least a positive trend on overall survival.”
Is median OS of 20.8 months in the ridaforolimus arm vs 19.6 months in the placebo arm (HR 0.93, p = 0.46) enough given possible safety concerns. My bet is that it'll be close but will ultimately be approved....hence the bumpy ride this morning.
