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IDYA-News
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Ideaya Biosciences Updates Darovasertib Clinical Data
Ideaya Biosciences announced updated clinical data from three ongoing studies evaluating darovasertib in metastatic and primary uveal melanoma, or UM, that will be presented at the European Society for Medical Oncology, or ESMO, Congress 2026, taking place on October 23-27 in Madrid, Spain. The updates will include Phase 2 expansion data from OptimUM-01 in HLA-A02:01-positive patients with metastatic uveal melanoma, or mUM, subgroup analyses from the registrational Phase 2/3 OptimUM-02 trial in first line, or 1L, HLA-A02:01-negative mUM and follow-up data from the Phase 2 OptimUM-09 trial evaluating neoadjuvant darovasertib in patients with primary UM. The combination demonstrated a profile across key measures of efficacy, including overall response rate, or ORR, disease control rate, or DCR, duration of response, or DOR, progression free survival, or PFS, and overall survival, or OS. Based on data from large meta-analyses published by Khoja and Rantala it has been shown that mUM has an especially poor prognosis, with a reported median PFS of 2.8 months and median OS of 12 months in the treatment-na ve setting. In the 2L setting, median PFS remains at 2-3 months but median OS drops to 8 months with a 1-year OS rate of 37%. As shown in the table above the data from OptimUM-01 compares favorably to these historical PFS and OS benchmarks, as well as to historical ORR which is typically 5%. Safety was manageable and generally consistent with previously reported results, with the most common treatment-related adverse events of diarrhea, nausea, peripheral edema, and vomiting. Related adverse events leading to treatment discontinuation occurred in 9 participants. Ideaya reported results from OptimUM-02 at the American Society of Clinical Oncology, or ASCO, demonstrating that 1L HLA A02:01 -negative mUM patients treated with the darovasertib combination had a median PFS of 6.9 months by blinded independent central review, or BICR, and 6.7 months by investigator assessment, compared to 3.1 months and 2.7 months in the investigator's choice of therapy, or ICT, control arm, respectively. The ESMO data builds on these results, showing consistent improvements in ORR and PFS compared to ICT across multiple clinically relevant subgroups, including baseline lactate dehydrogenase, or LDH, levels, ECOG performance status, largest target lesion size and choice of ICT used in the control arm. As expected, patients with higher tumor burden had a worse prognosis, however outcomes were still better with the darovasertib combination compared to ICT. OptimUM-09 is a Phase 2 trial evaluating single-agent darovasertib before local treatment in patients with primary uveal melanoma requiring enucleation, or surgical removal of the eye, or plaque brachytherapy. The primary endpoints for these cohorts are eye preservation rate and planned radiation dose reduction, respectively. The data in the ESMO abstract was from 116 patients treated with neoadjuvant darovasertib, including 66 patients in Cohort 1 and 50 patients in Cohort 2, as of a cutoff date of February 23, 2026, and is described below. However, the updated data to be presented at ESMO is from a total of 119 patients as of a cutoff date of June 15, 2026. Nonetheless, the data is largely consistent and continues to support the previously reported results from the trial, including at ESMO in 2025.
IDEAYA Biosciences Promotes Michael White to President, Research and Development
IDEAYA Biosciences announced the promotion of Dr. Michael White, from Chief Scientific Officer to President, Research and Development. White has served as CSO since 2021.
Ideaya Biosciences Doses First Patient in OptimUM-11 Trial
Ideaya Biosciences announced that the first patient has been dosed in OptimUM-11, a global Phase 3 registrational trial evaluating darovasertib, an oral protein kinase C inhibitor, in combination with crizotinib, an oral cMET inhibitor, as adjuvant therapy for patients with primary uveal melanoma who have completed local therapy and have an increased risk of developing metastatic disease. Currently, there are no approved adjuvant treatment options for patients with primary uveal melanoma.
Ideaya Biosciences Successfully Holds FDA Meeting, Plans Phase 3 Trial by End of 2026
Ideaya Biosciences (IDYA) announced a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a potential delta-like ligand 3, or DLL3-targeting Topo-I-payload antibody drug conjugate, in extensive stage small cell lung cancer. Ideaya is targeting to initiate the Phase 3 registrational study in ES-SCLC by year-end 2026. The anticipated enrollment target for the Ideaya-sponsored global Phase 3 registrational study is approximately 400 ES-SCLC patients with prior tarlatamab treatment. The study will be randomized 1:1 between the treatment and an investigator's choice control arm that will include topotecan and ambrucin. The primary endpoint for accelerated approval will be overall response rate by blinded independent central review and the primary endpoint for full approval will be median overall survival. The secondary endpoints will include median duration of response by BICR, progression free survival, safety, among others. Ideaya has an ongoing multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, and neuroendocrine carcinomas. The study is enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating the expansion doses of 2.4 mg/kg and 3.5 mg/kg IV once every 3-weeks to determine the recommended Phase 3 dose. In addition, IDE849 is being evaluated in clinical combination study with AstraZeneca's (AZN) PDL1 inhibitor Imfinzi, and IDEAYA's potential first-in-class Phase 1 PARG inhibitor, IDE161, to determine a potential first-line SCLC Phase 3 registrational trial design. IDE161 prevents the removal of poly chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NEC and melanoma, among others. Ideaya estimates the annual incidence of SCLC and NEC in the United States is approximately 34,000 and 19,000 patients, respectively. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.
Ideaya Enters Clinical Collaboration with Genentech
Ideaya Biosciences (IDYA) announced it has entered into a clinical collaboration with Genentech, a member of Roche (RHHBY), to evaluate the efficacy and safety of IDE892, its investigational MTA-cooperative PRMT5 inhibitor, in combination with GDC-7035, Genentech's KRAS G12D inhibitor, in patients with pancreatic ductal adenocarcinoma harboring both an MTAP-deletion and a KRAS G12D mutation. Genentech will sponsor the clinical combination study, and Ideaya will supply IDE892. Under the clinical collaboration, Ideaya and Genentech each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be joint governance to oversee the clinical supply collaboration.
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