Darovasertib cleared its primary endpoint in a phase 2/3 trial in metastatic uveal melanoma, posting median progression-free survival of 6.9 months against 3.1 months on the control arm. Ideaya shares jumped 18%, to above $36, in premarket trading Monday.
The result sets up an accelerated FDA filing in the second half of this year. Ideaya built the study to generate PFS data for accelerated approval, with overall survival data from a larger patient population set to convert that to full approval. OS results weren’t mature at cutoff, but the early trend favored darovasertib.
Servier paid Ideaya $210 million upfront last year for ex-U.S. rights to darovasertib. The deal includes $100 million in approval-based milestones, plus up to $220 million tied to commercial success. Servier is also collaborating on the adjuvant trial targeting relapses and progression.
Immunocore’s Kimmtrak won FDA approval in 2022 for unresectable or metastatic uveal melanoma, but only for HLA-A02:01-positive patients. Ideaya enrolled HLA-A02:01-negative patients, targeting a population Kimmtrak can’t reach.
The trial was powered to succeed if darovasertib topped 5.5 months PFS. The drug, combined with Pfizer’s Xalkori, ran against investigator’s choice of Opdivo and Yervoy. At 6.9 months, the result closely matched the 7.1-month median from phase 1/2 and cleared Ideaya’s own bar.
Accelerated approval filing: second half of this year.
— Sarah Chen