IDEAYA Biosciences Completes Targeted Full Enrollment in Randomized Pivotal Phase 2/3 Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA*A2-Negative Metastatic Uveal Melanoma

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ: IDYA) completed targeted full enrollment of 435 patients in the Phase 2/3 OptimUM-02 trial of darovasertib plus crizotinib in first-line HLA*A2-negative metastatic uveal melanoma.

Topline median progression-free survival (mPFS) data are expected in 1Q 2026 to support a potential accelerated approval filing in the United States; median overall survival (mOS) will support a potential full approval once available. Prior OptimUM-01 data showed 21.1 months mOS and 7.0 months mPFS.

Darovasertib holds FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations for specified uveal melanoma settings.

Positive

• Enrollment complete: 435 patients targeted for full approval filing
• mPFS data timeline: topline median PFS expected in 1Q 2026
• OptimUM-01 mOS: 21.1 months median overall survival reported
• Regulatory designations: FDA Breakthrough, Fast Track, and Orphan Drug designations

Negative

• OptimUM-01 mPFS: 7.0 months median PFS in Phase 2, a modest PFS outcome
• Regulatory outcome pending: accelerated/full approvals depend on future readouts
• Comparative arm: OptimUM-02 uses investigator's choice, which may affect cross-trial comparisons

Key Figures

Trial enrollment 435 patients Targeted full enrollment in OptimUM-02 Phase 2/3 mUM trial

Median OS 21.1 months Phase 1/2 OptimUM-01 darovasertib+crizotinib in 1L mUM

Median PFS 7.0 months Phase 1/2 OptimUM-01 darovasertib+crizotinib in 1L mUM

Topline timing 1Q 2026 Expected median PFS readout from OptimUM-02

Trial phase Phase 2/3 Pivotal OptimUM-02 randomized trial design

Median OS prior report 21.1 months Previously reported at Society for Melanoma Research Congress

Market Reality Check

$33.64 Last Close

Volume Volume 987,423 is at 1.04x the 20-day average of 947,163 shares. normal

Technical Shares at $33.64 are trading above the 200-day MA of $23.72 and 9.28% below the 52-week high.

Peers on Argus

Peers showed mixed moves: DNLI -3.99%, GLPG +1.35%, BLTE -0.90%, FOLD +0.72%, TVTX -0.38%. With IDYA down 1.29% pre-news and no peers in momentum scanners, trading appeared stock-specific rather than a coordinated biotech sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	IND clearance IDE034	Positive	+4.7%	FDA IND clearance for IDE034 bispecific ADC and Q1 2026 trial start.
Dec 01	IND clearance IDE034	Positive	-3.7%	Company announcement of FDA IND clearance for IDE034 targeting solid tumors.
Nov 28	Inducement grant	Neutral	-0.7%	Small stock option grant to a new hire under 2023 Inducement Plan.
Nov 24	IR events	Neutral	+2.0%	Announcement of CEO fireside chats at December healthcare conferences.
Nov 04	Earnings and update	Positive	-2.8%	Strong Q3 revenue from Servier deal and detailed pipeline milestones.

Pattern Detected

Recent news flow is largely positive, but price reactions are mixed, with several strong clinical and pipeline updates followed by both rallies and selloffs, indicating no consistent pattern of buying on good news.

Recent Company History

Over the last few months, IDEAYA reported multiple catalysts, including Q3 2025 results with $1.14B in cash and a $210M Servier upfront, several regulatory clearances for IDE034, and progress across darovasertib programs. Clinical timelines for OptimUM‑02 median PFS and new trials were already telegraphed in the Nov 4 earnings and Oct 20 8‑K. Today’s full enrollment milestone in OptimUM‑02 fits this ongoing execution narrative on uveal melanoma and broader pipeline expansion.

Market Pulse Summary

This announcement highlights completion of targeted full enrollment of 435 patients in the pivotal Phase 2/3 OptimUM‑02 trial of darovasertib plus crizotinib in first-line metastatic uveal melanoma, with median PFS data expected in 1Q 2026. It builds on prior OptimUM‑01 results showing 21.1-month median OS and 7.0-month median PFS. Investors may watch upcoming PFS and later OS readouts, regulatory interactions, and continued execution across related darovasertib programs.

Key Terms

progression-free survival medical

"Topline data, including median PFS, are expected in 1Q 2026"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Median overall survival (mOS) data from OptimUM-02, once available, will be used"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

breakthrough therapy designation regulatory

"Darovasertib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

fast track designation regulatory

"and Fast Track designation for darovasertib in combination with crizotinib"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

orphan drug regulatory

"Darovasertib has also been designated as an Orphan Drug by the U.S. FDA"

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

neoadjuvant medical

"Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary uveal melanoma"

"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.

overall response rate medical

"demonstrated a 21.1 month median OS and 7.0 months median PFS in 1L mUM"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

treatment-related adverse events medical

"common TRAEs >30% included diarrhea, nausea, edema, vomiting, dermatitis"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

AI-generated analysis. Not financial advice.

• Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial
• Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company's investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer's crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).  IDEAYA expects to report median progression-free survival (PFS) data from this trial in the first quarter 2026 to support a potential accelerated approval filing in the United States.  Median overall survival (mOS) data from OptimUM-02, once available, will be used to support a potential full approval filing.  Metastatic uveal melanoma is a rare, aggressive form of ocular cancer with limited treatment options and historically poor survival outcomes.

"We are very pleased to announce that we have achieved the target enrollment to enable potential full approval filing in our Phase 2/3 registration-enabling trial of darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. This milestone reflects both the clear unmet need in metastatic uveal melanoma, as well as the strong clinical interest in our darovasertib program. Moreover, the promising overall survival data and broader clinical efficacy demonstrated in the recently reported median overall survival results from the Phase 1/2 clinical trial (OptimUM-01) of this combination in metastatic uveal melanoma are indicative of the clinical potential of darovasertib to meaningfully impact patients with this devastating disease.  With target full enrollment now complete, we look forward to the availability of median PFS data we project from OptimUM-02 in the first quarter of next year, and, if approved, making darovasertib in combination with crizotinib available to patients with HLA*A2-negative metastatic uveal melanoma as a first-line treatment as expeditiously as possible," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

OptimUM-02 is a multi-arm, multi-stage, open-label Phase 2/3 trial with patients randomized to receive either the darovasertib and crizotinib combination or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).  The primary endpoints are median PFS and median OS, which will be used to support a potential accelerated approval and full approval in the United States, respectively.  In October 2025, IDEAYA presented data from its single-arm, Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination at the Society for Melanoma Research (SMR) Congress that demonstrated a 21.1 month median OS and 7.0 months median PFS in 1L mUM, including both HLA*A2-negative and HLA*A2-positive patients.

Darovasertib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary uveal melanoma (UM) and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in metastatic UM.  IDEAYA is currently enrolling patients in a pivotal Phase 3 trial of single-agent darovasertib in the neoadjuvant setting of primary UM (OptimUM-10). 

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.  Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.  We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.  Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical trial programs and updates, including enrollment achievements, regulatory updates, clinical trial data readouts; (ii) the potential for an accelerated and full approval for darovasertib; (iii) the potential therapeutic benefit of darovasertib, including in combination with crizotinib;  and (iv) the timing of development and regulatory milestones.  Clinical trial results, preliminary or otherwise, are not necessarily predictive of future clinical trial results and/or approval.  Neither Breakthrough Therapy nor Orphan Drug Designation necessarily translates into approval of the drug. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing and commercializing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact

IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer  
investor@ideayabio.com

 

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What did IDEAYA announce about enrollment in OptimUM-02 (IDYA) on December 11, 2025?

IDEAYA announced completion of targeted full enrollment of 435 patients in the OptimUM-02 Phase 2/3 trial.

When will IDEAYA (IDYA) report median PFS from OptimUM-02?

Topline median PFS data are expected in 1Q 2026 to support a potential accelerated approval filing in the U.S.

What were the OptimUM-01 clinical results IDEAYA cited for darovasertib plus crizotinib?

OptimUM-01 reported a 21.1-month median overall survival and a 7.0-month median PFS in first-line metastatic uveal melanoma.

How will OptimUM-02 endpoints be used for FDA filings for IDEAYA (IDYA)?

The trial's median PFS will support a potential accelerated approval and median OS will support a potential full approval in the United States.

What regulatory designations does darovasertib have for uveal melanoma?

Darovasertib has FDA Breakthrough Therapy designation (neoadjuvant enucleation-recommended primary UM), Fast Track for the combination in metastatic UM, and Orphan Drug designation in UM.

What treatments will OptimUM-02 compare darovasertib plus crizotinib against?

Patients are randomized to the combination or investigator's choice of pembrolizumab, ipilimumab + nivolumab, or dacarbazine.