IDEAYA Biosciences Inc. (NASDAQ: IDYA) said its lead precision oncology drug, darovasertib, extended progression-free survival by 122% in a pivotal trial for first-line metastatic melanoma, putting the company on track for its first New Drug Application (NDA) submission.
"Great result, really puts us on track for that NDA submission,” Yujiro Hata, IDEAYA’s chief executive officer, said during a presentation at the Bank of America Global Healthcare Conference.
The OptimUM-02 study showed a median progression-free survival of 6.9 months in the treatment arm, compared with 3.1 months for the control arm, which used standard-of-care checkpoint inhibitors and chemotherapy. The result translated to a hazard ratio of 0.42 with a p-value of less than 0.0001, indicating high statistical significance.
The positive data significantly de-risks IDEAYA's lead asset and targets a key unmet need in HLA-A2-negative melanoma, a market of roughly 1,500 U.S. patients with no currently approved therapy. With a cash runway into 2027, the company is positioned to fund its commercial preparations and advance a deep pipeline of other targeted cancer therapies.
IDEAYA is targeting an accelerated approval pathway with the FDA, which it recently engaged under the Real-Time Oncology Review (RTOR) program. The company plans to present a fuller dataset, including overall survival trends and safety data, at the American Society of Clinical Oncology (ASCO) meeting on June 1.
The company's approach centers on synthetic lethality, a strategy that uses drugs to exploit specific genetic vulnerabilities in cancer cells while sparing healthy tissue. In this trial, darovasertib targets Protein Kinase C (PKC), a key pathway in uveal and metastatic melanomas.
Beyond the initial HLA-A2-negative group, IDEAYA is exploring darovasertib in the adjuvant (post-surgery) setting with a 450-patient, HLA-agnostic Phase 3 study. "There is currently nothing approved in the adjuvant setting," Hata noted, suggesting the potential for rapid trial enrollment.
IDEAYA also highlighted progress in its broader pipeline, particularly IDE849, a DLL3-targeted antibody-drug conjugate. The company and its partner in China, Hengrui, both plan to initiate registrational studies by the end of the year for small cell lung cancer and neuroendocrine carcinoma.
Hata described the upcoming data from Hengrui's Phase 1 study in China, expected in the second half of the year, as potentially "very de-risking" for the asset class. That update is expected to include data from over 100 patients.
The company's pipeline also includes programs targeting MTAP-deletion tumors with MAT2A and PRMT5 inhibitors, further cementing its focus on genetically-defined cancers.
This article is for informational purposes only and does not constitute investment advice.
