Congratulations! First Phase 3 trial just started by Novartis
Official Title: A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
It is on Clinicaltrials.gov
I thought the really important news coming out of JPM was that ARRY got permission from the FDA to use HI (hematological improvement) as the primary endpoint in the 614 (pivotal?) trials. This is a much lower hurdle than having to use overall survival (OS). And it provides a much faster timeline to approval. I don't think the Market has yet understood the importance of this.
That 520 CR in combination with Carfilzomab is impressive, especially in such a tiny patient population.
I hope ARRY can partner out 520 and 797 and concentrate internal development on 614.
P.S. There must be some milestone from NVS to ARRY for starting the Phase III's. My guess would be around $10 million.