IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program

Rhea-AI Summary

IDEAYA (NASDAQ: IDYA) will initiate an FDA RTOR submission for darovasertib plus crizotinib in first-line HLA*A2-negative metastatic uveal melanoma following positive Phase 2/3 OptimUM-02 topline results. The trial met its primary endpoint: PFS 6.9 vs 3.1 months (HR 0.42; 95% CI 0.30-0.59; p<0.0001).

IDEAYA plans the first RTOR pre-submission in May and expects NDA completion in H2 2026; full results to be presented at ASCO 2026.

Positive

• PFS improvement: median 6.9 vs 3.1 months
• Risk reduction: 58% lower progression risk (HR 0.42)
• ORR: 37.1% with 5 complete responses
• RTOR acceptance: FDA agreed to review under OCE RTOR

Negative

• OS immature: overall survival data not yet mature
• Potential regulatory timeline risk: NDA completion expected H2 2026 (timing not guaranteed)
• Safety: known side-effects noted; tolerability described as manageable (monitoring needed)

News Market Reaction – IDYA

+3.74%

+3.74% Session close to close

In the Apr 30 session, IDYA gained 3.74%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights that OptimUM-02 met its primary endpoint and that IDEAYA plans an RTOR-...

Analysis

This announcement highlights that OptimUM-02 met its primary endpoint and that IDEAYA plans an RTOR-enabled NDA submission based on a hazard ratio of 0.42, median PFS of 6.9 vs 3.1 months, and ORR of 37.1% vs 5.8%. In recent months, the company has advanced multiple programs from first‑patient‑in Phase 1 trials to positive Phase 2/3 data and an upcoming ASCO 2026 presentation. Key factors to watch include full data at ASCO, NDA filing progress, and safety durability over longer follow-up.

Key Figures

Risk reduction: 58% Hazard ratio: 0.42 PFS (combo vs ICT): 6.9 vs 3.1 months +5 more

8 metrics

Risk reduction 58% Reduction in risk of disease progression vs ICT arm

Hazard ratio 0.42 Primary endpoint, 95% CI: 0.30–0.59

PFS (combo vs ICT) 6.9 vs 3.1 months Median progression-free survival by BICR

P-value (PFS) <0.0001 Statistical significance for primary endpoint

ORR (combo vs ICT) 37.1% vs 5.8% Overall response rate comparison

Complete responses 5 Number of complete responses in darovasertib combination arm

Median DOR 6.8 months Median duration of response in darovasertib combination arm

Median PFS (ICT) 3.1 months Investigator choice of therapy arm

Previous Clinical trial Reports

5 past events · Latest: Apr 21 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 21	ASCO LBA announcement	Positive	-5.3%	Announced late-breaking ASCO 2026 oral presentation with full OptimUM-02 data.
Apr 13	Topline trial results	Positive	+7.6%	Reported positive Phase 2/3 OptimUM-02 topline efficacy and safety data.
Apr 06	Phase 1 FPI IDE574	Positive	-1.2%	First-patient-in for IDE574 Phase 1 in multiple solid tumor indications.
Mar 30	Phase 1 combo FPI	Positive	+3.3%	First-patient-in for IDE849 plus IDE161 combo study in DLL3-upregulated tumors.
Mar 09	Phase 1 FPI IDE892	Positive	+5.7%	First-patient-in for IDE892 Phase 1 in MTAP-deleted solid tumors and pipeline update.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical updates often move the stock, with a mix of positive and negative reactions despite generally positive trial news.

Recent Company History

Over recent months, IDEAYA has repeatedly highlighted its clinical pipeline. Earlier April news detailed positive Phase 2/3 OptimUM-02 topline results for darovasertib plus crizotinib in first-line metastatic uveal melanoma and scheduled a late-breaking ASCO 2026 presentation. Additional releases reported first‑patient‑in milestones for multiple Phase 1 programs (IDE574, IDE849 plus IDE161, and IDE892). Today’s RTOR/NDA-focused announcement builds directly on those OptimUM‑02 data and the planned NDA in H2 2026.

Key Terms

new drug application (nda), real-time oncology review (rtor), phase 2/3, progression-free survival (pfs), +4 more

8 terms

new drug application (nda) regulatory

"agreed to review its New Drug Application (NDA) for darovasertib in combination"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

real-time oncology review (rtor) regulatory

"under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program"

Real-Time Oncology Review (RTOR) is a regulatory program that lets drug regulators review key clinical data as it becomes available instead of waiting for a finished application, so the assessment can proceed in parallel with the company's final submission. For investors, RTOR matters because it can shorten the time between final data and a decision—like letting an inspector check a building while it's being finished—reducing approval uncertainty and potentially accelerating a therapy’s market entry and revenue timing.

phase 2/3 medical

"Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint"

A phase 2/3 trial is a combined clinical study that first evaluates how well a treatment works and the best dose, then expands into a larger test to confirm those results and safety. For investors, it matters because moving into a phase 2/3 signals that an experimental therapy has shown initial promise and will be tested at scale, which can materially change the odds and timeline for regulatory approval and commercial potential.

progression-free survival (pfs) medical

"improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months"

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

overall response rate (orr) medical

"On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete"

Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.

duration of response (dor) medical

"with a median duration of response (DOR) of 6.8 months"

Duration of response (DOR) measures how long a meaningful positive reaction to a treatment lasts before the disease worsens or returns. Think of it as a stopwatch that starts when a patient improves and stops when that improvement ends; longer times suggest a treatment’s benefit is more reliable. For investors, DOR helps judge a drug’s commercial staying power, pricing power, and likelihood of regulatory approval or broader adoption.

overall survival (os) medical

"Overall survival (OS) data were not yet mature, however the darovasertib combination"

Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.

blinded independent central review (bicr) medical

"as assessed by blinded independent central review (BICR)"

A blinded independent central review (BICR) is a process in clinical trials where outside experts, who do not know which patients received the experimental treatment, centrally re-check key medical data (often images or test results) to confirm outcomes. Investors care because BICR reduces bias and disagreement in trial results—think of neutral referees reviewing game footage without team colors—so findings are more credible for regulators, partners and valuation decisions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint and will be presented in a late-breaking oral presentation at ASCO 2026
• IDEAYA to initiate the RTOR submission process with the first pre-submission in May, with completion of the NDA filing expected in H2 '26

SOUTH SAN FRANCISCO, Calif., April 30, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.

"We are grateful for the continued partnership with the FDA and being accepted in the Oncology Center of Excellence Real-Time Oncology Review program based on the topline results from the OptimUM-02 trial.  This is an important achievement for IDEAYA and the people living with mUM who today have very few treatment options.  We believe the topline results from OptimUM-02 provide further evidence to support the potential benefit of the darovasertib combination in patients with first-line HLA*A2-negative mUM, and we look forward to working closely with the FDA through the RTOR process to make this promising new potential treatment available to patients as quickly as possible," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

On April 13^th, IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib in 1L HLA*A2-negative mUM.  The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR).  On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months.  Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm.  The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.

The FDA's OCE RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. IDEAYA plans to initiate the RTOR submission process with the first pre-submission targeted for May, with completion of the NDA filing expected in the second half of 2026.

Full results from the OptimUM-02 trial will be presented in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) annual meeting, taking place in Chicago, Illinois.  IDEAYA is also conducting clinical trials of darovasertib in HLA*A2-positive mUM as well as in the neoadjuvant and adjuvant settings of primary uveal melanoma.  

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.  IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/ 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding IDEAYA Biosciences' plans to initiate and complete a New Drug Application (NDA) submission for darovasertib under the FDA's Real-Time Oncology Review (RTOR) program; the timing of such submission; the potential for RTOR to enable a more efficient review process; the anticipated presentation of clinical data; the potential therapeutic benefit, safety, and tolerability of darovasertib in combination with crizotinib; the potential for regulatory approval; and the ability of darovasertib to address unmet medical needs in patients with metastatic uveal melanoma. These forward-looking statements are based on IDEAYA's current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks related to the timing and success of the NDA submission and acceptance; the FDA's review process and decisions, including whether RTOR will result in a more efficient review timeline; the completeness and quality of the data submitted; the ability to successfully present and interpret clinical data; the risk that topline or interim data may not be predictive of final results; the potential for delays in clinical development or regulatory interactions; the risk that darovasertib in combination with crizotinib may not demonstrate sufficient safety or efficacy in further analyses; and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

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 (IDYA) announce about the OptimUM-02 trial results on April 30, 2026?

IDEAYA announced that OptimUM-02 met its primary endpoint with PFS 6.9 vs 3.1 months and HR 0.42. According to IDEAYA, the darovasertib plus crizotinib combination reduced progression risk by 58% and produced a 37.1% overall response rate.

What is IDEAYA's timeline for the darovasertib NDA and RTOR submission for IDYA?

IDEAYA plans a first RTOR pre-submission in May and expects NDA completion in H2 2026. According to IDEAYA, the FDA agreed to review components under the Oncology Center of Excellence Real-Time Oncology Review program.

How did darovasertib plus crizotinib perform versus investigator choice therapy in OptimUM-02?

The combination achieved median PFS of 6.9 months versus 3.1 months for investigator choice therapy. According to IDEAYA, the difference was statistically significant (HR 0.42; 95% CI 0.30-0.59; p<0.0001).

What efficacy secondary endpoints did IDEAYA report for darovasertib in OptimUM-02?

IDEAYA reported an overall response rate of 37.1% including five complete responses and a median duration of response of 6.8 months. According to IDEAYA, the ORR vs ICT was statistically significant (p<0.0001).

Will IDEAYA present full OptimUM-02 data at a medical meeting and when?

Yes. IDEAYA will present full OptimUM-02 results in a late-breaking oral presentation at ASCO 2026. According to IDEAYA, the presentation will occur at the American Society of Clinical Oncology annual meeting in Chicago.