A phase 2/3 trial of Ideaya Biosciences and Servier’s eye cancer candidate has hit its primary endpoint, teeing up a filing for accelerated FDA approval in the second half of the year.
Investigators randomized 210 people with metastatic uveal melanoma to receive Ideaya and Servier’s protein kinase C inhibitor, darovasertib, in combination with Pfizer’s Xalkori. Another 103 participants received investigator’s choice of therapy, typically the combination of Bristol Myers Squibb’s checkpoint inhibitors Opdivo and Yervoy.
Median progression-free survival (PFS) was 6.9 months in the darovasertib arm compared to 3.1 months in the control group, hitting the trial’s primary endpoint. Ideaya shares initially jumped 18% to above $36 in premarket trading Monday.
The result closely matched expectations set by Ideaya. Darovasertib plus Xalkori achieved a median PFS of 7.1 months in a phase 1/2 trial. At a Citi event in February, Ideaya CEO Yujiro Hata pointed out that historically the treatments used in the trial’s control arm have achieved a median PFS of about three months. The data led Ideaya to power its trial to succeed if PFS on the darovasertib regimen topped 5.5 months.
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Having cleared that threshold, Ideaya plans to file for FDA approval. The biotech designed the study to generate PFS data for accelerated approval and deliver overall survival (OS) results from a larger patient population to support the conversion to full approval. Ideaya said the OS data were immature as of the cutoff but the early trend favored darovasertib.
Immunocore won FDA approval for the HLA-directed CD3 T-cell engager Kimmtrak in unresectable or metastatic uveal melanoma in 2022. However, the Kimmtrak approval only covers HLA-A*02:01-positive patients.
Ideaya enrolled HLA-A*02:01-negative patients in its phase 2/3 study, positioning it to target a largely untapped opportunity. But the biotech’s ambitions extend beyond the subpopulation. Across several trials, Ideaya aims to show darovasertib shrinks tumors to prevent the need for eye removal, stops relapses or delays progression and prolongs survival in a broad population including HLA-A*02:01-positive patients.
Servier is collaborating with Ideaya on the adjuvant trial tackling relapses and progression. The French drugmaker paid Ideaya $210 million upfront for ex-U.S. rights to darovasertib last year. The deal includes $100 million in approval-based milestones, plus up to $220 million tied to commercial success.
