IDEAYA Biosciences and Servier announced that their investigational combination therapy met the primary endpoint in a mid-to-late-stage clinical trial for metastatic uveal melanoma, a rare form of eye cancer. The results led to a rise in IDEAYA’s share price in premarket trading on Monday.
The study evaluated darovasertib, a protein kinase C inhibitor, used alongside Pfizer’s Xalkori. The combination demonstrated a median progression-free survival of 6.9 months, compared with 3.1 months in patients receiving treatments selected by investigators. These comparator therapies included Merck’s Keytruda or a combination of Bristol Myers Squibb’s Opdivo and Yervoy, which are commonly used off-label for this disease.
A total of 210 patients with metastatic uveal melanoma were assigned to receive the darovasertib combination, while 103 participants were treated with investigator-selected therapies. The improvement in progression-free survival met the trial’s main goal. Additionally, five patients in the darovasertib arm experienced complete responses, indicating no detectable signs of cancer.
Uveal melanoma is an aggressive cancer that often spreads to other organs, particularly the liver. According to the companies, approximately 10,000 new cases are diagnosed each year globally. Among patients whose cancer has metastasized, between 50% and 70% are HLA-A*02:01-negative, a subgroup specifically targeted in this study.
IDEAYA plans to submit an application for U.S. Food and Drug Administration approval in the second half of the year. The trial was designed to support accelerated approval based on progression-free survival data, while also collecting overall survival data to support a potential transition to full approval. At the time of analysis, overall survival data were not yet mature, though early trends favored the darovasertib regimen.
The findings were consistent with earlier clinical data. In a prior phase 1/2 study, the combination achieved a median progression-free survival of 7.1 months. IDEAYA structured the phase 2/3 trial to succeed if the regimen exceeded 5.5 months in progression-free survival, a benchmark informed by historical outcomes of approximately three months for existing therapies.
IDEAYA CEO Yujiro Hata previously noted that the control therapies used in the trial have historically delivered progression-free survival of around three months. The current results surpassed that level, supporting the company’s decision to proceed with regulatory filing.
The treatment landscape for uveal melanoma remains limited. Immunocore’s Kimmtrak, approved in 2022, is restricted to patients who are HLA-A02:01-positive. By focusing on HLA-A02:01-negative patients, IDEAYA and Servier are targeting a population not covered by that approval.
Across several trials, IDEAYA aims to show darovasertib can shrink tumors to prevent the need for eye removal, delay or stop disease progression, prevent relapse, and extend survival in a broader population, including HLA-A*02:01-positive patients.
Servier is collaborating with IDEAYA on multiple aspects of the program, including an adjuvant trial focused on preventing relapse and disease progression. As part of their partnership, Servier paid $210 million upfront for rights to darovasertib outside the United States. The agreement also includes up to $100 million in regulatory milestone payments and as much as $220 million tied to commercial performance.
Truist analyst Gregory Renza stated, “the brokerage expects $800 million in peak annual revenue for darovasertib to treat the disease.”
IDEAYA Trial Meets Key Endpoints
The Phase 2/3 study demonstrated that the darovasertib combination significantly improved progression-free survival in patients with metastatic uveal melanoma. Patients treated under the IDEAYA-led program experienced a median progression-free survival of approximately 6.9 months, compared to 3.1 months with standard treatments.
This strong efficacy signal highlights the potential of IDEAYA’s approach to address a disease with historically poor outcomes and limited treatment options.
Understanding Uveal Melanoma and Treatment Need
Uveal melanoma is a rare but highly aggressive eye cancer that often spreads to other organs, particularly the liver. Traditional therapies have delivered limited benefits, leaving a significant unmet need in this space.
By advancing this therapy, IDEAYA is targeting a patient population that has lacked effective systemic treatments, particularly those not eligible for existing immunotherapies.
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