IDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at ASCO

Rhea-AI Summary

IDEAYA Biosciences (Nasdaq: IDYA) and Servier reported complete Phase 2/3 OptimUM-02 data for the darovasertib + crizotinib combination in first-line HLA*A2:01 negative metastatic uveal melanoma.

The regimen significantly improved median PFS, ORR and DCR versus investigator’s choice, showed a manageable safety profile, and is under FDA RTOR review with NDA completion targeted in H2 2026.

AI-generated analysis. Not financial advice.

Positive

• Median PFS 6.9 vs 3.1 months by BICR; HR 0.42; p<0.0001
• ORR 37.1% vs 5.8% and DCR 73.3% vs 31.1% by BICR
• Risk of disease progression reduced 58% by BICR, 64% by investigator
• Low discontinuation rates due to TRAEs for darovasertib 2.5% and crizotinib 10%
• TR-SAEs 9.2% with darovasertib combination vs 25.0% with investigator’s choice
• FDA reviewing NDA under RTOR; filing completion expected in H2 2026

Negative

• Overall survival data still immature; full approval will depend on future OS results
• Grade 3/4 treatment-related adverse events in 40.6% vs 37.0% with investigator’s choice
• Median relative dose intensity 77.1% for crizotinib vs 100% in control arm

News Market Reaction – IDYA

-1.80%

1 alert

-1.80% News Effect

-$47M Valuation Impact

$2.59B Market Cap

2.05K Volume

On the day this news was published, IDYA declined 1.80%, reflecting a mild negative market reaction. This price movement removed approximately $47M from the company's valuation, bringing the market cap to $2.59B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Median PFS (BICR): 6.9 vs 3.1 months Hazard ratio (PFS): HR 0.42; 95% CI 0.30–0.59; p<0.0001 ORR (BICR): 37.1% vs 5.8% +5 more

8 metrics

Median PFS (BICR) 6.9 vs 3.1 months Darovasertib combo vs ICT, primary endpoint

Hazard ratio (PFS) HR 0.42; 95% CI 0.30–0.59; p<0.0001 OptimUM-02 primary endpoint by BICR

ORR (BICR) 37.1% vs 5.8% Darovasertib combo vs ICT

DCR (BICR) 73.3% vs 31.1% Darovasertib combo vs ICT

Median DOR 6.8 months By BICR and investigator assessment

TR-SAE rate 9.2% vs 25.0% Darovasertib combo vs ICT arms

Grade 3/4 TRAEs 40.6% vs 37.0% Darovasertib combo vs ICT

Trial size 313 patients Global Phase 2/3 OptimUM-02 trial

Market Reality Check

Price: $29.22 Vol: Volume 891,806 vs 20-day ...

normal vol

$29.22 Last Close

Volume Volume 891,806 vs 20-day average 786,870, indicating slightly elevated trading interest. normal

Technical Shares at $29.47, trading below the 200-day MA $30.89 and about 25% under the 52-week high.

Peers on Argus

IDYA gained 0.44% on the day, while close biotech peers showed mixed moves (e.g....

1 Down

IDYA gained 0.44% on the day, while close biotech peers showed mixed moves (e.g., DNLI +0.94%, GLPG -2.8%, BLTE -1.46%, TVTX -1.21%). Momentum scanner only flagged BEAM, down 6.36%, suggesting IDYA’s action was company-specific rather than sector-driven.

Previous Clinical trial Reports

5 past events · Latest: Apr 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 30	RTOR NDA plan	Positive	+3.7%	Announced RTOR-based NDA initiation after positive OptimUM-02 topline data.
Apr 21	ASCO presentation plan	Positive	-5.3%	Disclosed late-breaking ASCO oral slot to present full OptimUM-02 data.
Apr 13	Topline trial results	Positive	+7.6%	Reported positive topline OptimUM-02 results with improved PFS and ORR.
Apr 06	Phase 1 IDE574 start	Positive	-1.2%	Announced first‑patient‑in for Phase 1 trial of IDE574 in solid tumors.
Mar 30	IDE849 combo trial	Positive	+3.3%	First‑patient‑in for Phase 1 combo of IDE849 and IDE161 in DLL3 tumors.

Pattern Detected

Clinical trial news has often led to positive reactions, though there are notable negative divergences on some updates and scheduling announcements.

Recent Company History

Over recent months, IDEAYA has repeatedly highlighted darovasertib plus crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. Positive topline data on Apr 13 and the NDA/RTOR plan on Apr 30 saw gains, while an ASCO scheduling announcement on Apr 21 drew a selloff. Earlier, first‑patient‑in updates for IDE574 and the IDE849/IDE161 combination showed mixed share reactions. Today’s full ASCO data reinforce the same core efficacy and safety story from OptimUM‑02.

Historical Comparison

+1.6% avg move · In the past months, IDYA’s five clinical‑trial headlines averaged a 1.62% move. Today’s detailed ASC...

clinical trial

+1.6%

Average Historical Move clinical trial

In the past months, IDYA’s five clinical‑trial headlines averaged a 1.62% move. Today’s detailed ASCO data with a 0.44% gain fits within this historically moderate reaction range.

Clinical news has progressed from first‑patient‑in Phase 1 studies to positive OptimUM‑02 topline results, then to RTOR/NDA planning and now full registrational data presented at ASCO for darovasertib plus crizotinib.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-05-05

An effective automatic shelf registration on Form S-3ASR dated May 5, 2026 allows IDEAYA to offer common stock, preferred stock, debt securities, warrants, and units from time to time via various methods, with specific terms set in future prospectus supplements.

Market Pulse Summary

This announcement delivers full Phase 2/3 OptimUM‑02 data showing meaningful gains in PFS, ORR and D...

Analysis

This announcement delivers full Phase 2/3 OptimUM‑02 data showing meaningful gains in PFS, ORR and DCR for darovasertib plus crizotinib, alongside a manageable safety profile. It builds on earlier topline updates and supports the ongoing NDA process under the RTOR program targeting completion in H2 2026. Investors may track upcoming overall survival readouts, potential regulatory milestones, and any capital raises under the active S‑3ASR shelf as key follow-ons.

Key Terms

progression free survival, overall response rate, disease control rate, blinded independent central review, +4 more

8 terms

progression free survival medical

"statistically significant and clinically meaningful improvement in median PFS vs..."

Progression free survival is the length of time during and after a treatment when a disease, such as cancer, does not get worse or spread. It is an important measure because longer periods of stability can indicate that a treatment is effectively controlling the condition. For investors, it provides insight into the potential durability and success of a therapy or medication.

overall response rate medical

"Significantly improved ORR (37.1% vs 5.8%) and DCR (73.3% vs. 31.1%)..."

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.

disease control rate medical

"Significantly improved ORR (37.1% vs 5.8%) and DCR (73.3% vs. 31.1%)..."

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

blinded independent central review medical

"The primary endpoint to support accelerated approval is median progression-free survival (PFS) as assessed by blinded independent central review (BICR)."

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

hazard ratio medical

"HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

treatment-related adverse events medical

"Grade 3/4 treatment-related adverse events (TRAEs) occurred in 40.6%..."

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.

overall survival medical

"Overall survival (Primary endpoint of the Phase 3 portion)"

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.

Real-time Oncology Review regulatory

"review their new drug application (NDA) for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-time Oncology Review (RTOR) program."

A regulatory process in which reviewers assess clinical data and application materials for a cancer therapy as they are submitted, instead of waiting for a complete package. By allowing questions to be answered and issues resolved during the submission rather than afterward, it can speed up decisions and reduce surprise delays. For investors, that means greater predictability around potential approvals or setbacks and a faster path to a drug reaching the market, similar to editing a book chapter-by-chapter rather than after the whole manuscript is finished.

AI-generated analysis. Not financial advice.

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• Darovasertib combination resulted in a statistically significant and clinically meaningful improvement in median PFS vs. investigator's choice of therapy (ICT) – 6.9 months vs. 3.1 months, HR: 0.42, 58% reduction in risk of disease progression
• Significantly improved ORR (37.1% vs 5.8%) and DCR (73.3% vs. 31.1%) by BICR vs. ICT, where ~77% were treated with ipilimumab + nivolumab
• OS not yet mature but early trend favoring the darovasertib combination; targeting to provide the next update as part of the pre-specified interim analysis  
• Manageable safety profile consistent with prior results, with a low rate of TR-SAE (9.2%) and discontinuations due to TRAEs for darovasertib (2.5%) and crizotinib (10%)
• NDA submission in process under RTOR program; expect to complete filing in H2 2026

SOUTH SAN FRANCISCO, Calif., June 1, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, today presented complete data from the primary analysis of their registrational Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2:01 negative metastatic uveal melanoma (mUM) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois.  The data were provided in a late-breaking oral presentation by Dr. Marlana Orloff, M.D., Professor of Medical Oncology at Thomas Jefferson University Hospital and lead investigator on the trial.  A copy of the presentation will be available on IDEAYA's corporate website.

"The data from OptimUM-02 represent an exciting step forward in the treatment landscape for metastatic uveal melanoma, particularly for patients with HLA*A2:01 negative disease who have no approved treatment options," said Dr. Orloff.  "The darovasertib combination drove consistent, robust and clinically meaningful improvements in response rate and progression free survival relative to checkpoint inhibitors that are commonly used today and supports its potential as a new therapeutic standard for patients with this devastating disease."

OptimUM-02 is a global, registrational Phase 2/3 trial evaluating a total of 313 patients with 1L HLA*A2:01 negative mUM, randomized 2:1 to the darovasertib combination or an investigator's choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1).  The primary endpoint to support accelerated approval is median progression-free survival (PFS) as assessed by blinded independent central review (BICR).  Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response.  Data presented at ASCO were as of a cutoff date of January 23, 2026 and included additional detail on baseline characteristics as well as safety, secondary endpoints and median PFS across patient subgroups.

Key Findings from OptimUM-02

• Primary endpoint (Phase 2 portion): progression free survival by BICR
  • The trial met the primary endpoint, with patients treated with the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001).
  • Patients treated with the darovasertib combination also had a statistically significant improvement in median PFS of 6.7 months versus 2.7 months for ICT by investigator assessment (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).
  • Notably, the darovasertib combination reduced the risk of disease progression by 58% and 64% as assessed by BICR and investigator assessment, respectively.
  • Treatment with the darovasertib combination demonstrated a consistent and meaningful improvement in median PFS relative to the ICT arm across a broad range of patient subgroups, including age and gender, type of immune therapy used in ICT, LDH stratification, ECOG status and site of metastasis.
• Secondary endpoints: ORR, DCR, duration of response
  • Patients treated with the darovasertib combination had an ORR of 37.1% (78/210) and 39.5% (83/210) as assessed by BICR and investigator, respectively, compared to 5.8% (6/103) and 1.9% (2/103) in the ICT arm (p-value: <0.0001).
  • The darovasertib combination led to a disease control rate of 73.3% (154/210) and 74.3% (156/210) by BICR and investigator assessment, respectively, compared to 31.1% (32/103) and 27.2% (28/103) in the ICT control arm. 
  • The median duration of response was 6.8 months (95% CI: 5.5, 11.3) by BICR and 6.8 months (95% CI: 4.8, 9.7) by investigator assessment based on a median follow-up time of 7.4 months as of the cutoff date.
• Overall survival (Primary endpoint of the Phase 3 portion)
  • As noted in the topline results, data on overall survival (OS) was still immature as of the cutoff date, however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm.
    • IDEAYA will provide the next OS update as part of the pre-specified interim analysis.  Overall survival data, when available, will be used to support a potential full approval in the United States and globally.    
• Safety
  • The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with previous results and known side-effects of each agent alone.
  • Median relative dose intensities of darovasertib and crizotinib were 91.0% and 77.1%, respectively, compared to 100% for the ICT arm.
  • Grade 3/4 treatment-related adverse events (TRAEs) occurred in 40.6% (97/239) of patients in the darovasertib combination arm compared to 37.0% (37/100) of patients in the ICT control arm.
    • Treatment-related serious adverse events (TR-SAE) were 9.2% (22/239) and 25.0% (25/100) in the darovasertib combination and ICT arms, respectively.
    • Low discontinuation rate due to TRAEs for darovasertib (2.5%) and crizotinib (10.0%) relative to ICT (19.0%).
  • The most common Grade 3/4 TRAEs included diarrhea (10.0%), syncope (7.1%) and hypotension (3.8.%) in the darovasertib combination arm compared to elevated liver enzymes (ALT, 7.0% / AST, 7.0%), diarrhea (6.0%), hepatitis (5.0%) and colitis (4.0%) in the ICT control arm.

In April 2026, IDEAYA announced the U.S. Food and Drug Administration (FDA) has agreed to review their new drug application (NDA) for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-time Oncology Review (RTOR) program.  This program allows applicants to pre-submit components of their 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 completed its first pre-submission in May and expects to complete the NDA filing in the second half of 2026.

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.

About Servier

Servier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle. 

As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to offer targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D. 

Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion. 

More information on the Group website: servier.com  

Follow us on social media: LinkedIn, Facebook, X, Instagram  

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding: the potential therapeutic benefit, safety, tolerability and clinical activity of darovasertib in combination with crizotinib; the potential significance and implications of data from the Phase 2/3 registrational OptimUM-02 trial; expectations regarding overall survival analyses and timing of interim data updates; IDEAYA's plans and expectations regarding regulatory submissions, including the timing and completion of the NDA submission under the FDA's Real-Time Oncology Review (RTOR) program; the potential for accelerated approval and/or full approval of darovasertib in combination with crizotinib in the United States and globally; and IDEAYA's strategy, business plans and objectives.  Such forward-looking statements are based on IDEAYA's current expectations, estimates, assumptions, and beliefs regarding future events and are subject to substantial risks and uncertainties that could cause actual results, outcomes or events to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others: risks related to the discovery, development and regulatory approval of drug candidates; risks related to the timing, progress and results of clinical trials, including uncertainties regarding enrollment, safety, efficacy and durability of response; risks that clinical trial results may not be replicated in future studies or support regulatory approval; risks related to regulatory interactions, submissions and decisions, including the timing and outcome of NDA review processes; risks related to manufacturing and supply; risks related to competition and changes in the standard of care; the timing and success of  commercialization efforts; the outcome of collaborations and licensing arrangements; IDEAYA's dependence on third parties; risks related to intellectual property protection; and risks related to IDEAYA's ability to obtain, maintain and enforce intellectual property rights for its product candidates.  Additional risks and uncertainties that could affect IDEAYA's business and results are described under the caption "Risk Factors" 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 filed with the SEC. Forward-looking statements contained in this press release are made only as of the date hereof, and IDEAYA undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contacts

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

Servier
Laura Visserias
laura.visserias.part@servier.com

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What were the key results from IDEAYA’s OptimUM-02 trial in metastatic uveal melanoma (IDYA)?

The darovasertib plus crizotinib combination significantly improved median PFS, ORR and DCR versus investigator’s choice. According to IDEAYA, BICR-assessed median PFS was 6.9 vs 3.1 months, with an ORR of 37.1% vs 5.8% and DCR of 73.3% vs 31.1%.

How much did darovasertib combination improve progression-free survival in OptimUM-02 for IDYA?

Darovasertib plus crizotinib nearly doubled progression-free survival versus investigator’s choice. According to IDEAYA, BICR-assessed median PFS was 6.9 months versus 3.1 months, with a hazard ratio of 0.42, reflecting a 58% reduction in the risk of disease progression in treated patients.

What overall response and disease control rates were achieved with darovasertib in OptimUM-02 (IDYA)?

The combination showed markedly higher response and disease control rates than control therapy. According to IDEAYA, BICR-assessed ORR was 37.1% vs 5.8%, while DCR reached 73.3% vs 31.1%, with median duration of response of 6.8 months after 7.4 months median follow-up.

What does the OptimUM-02 safety profile indicate for IDEAYA’s darovasertib combination?

The regimen showed a generally manageable safety profile with notable serious event differences. According to IDEAYA, Grade 3/4 TRAEs occurred in 40.6% of combination patients, but TR-SAEs were 9.2% versus 25.0% with investigator’s choice, and discontinuations from darovasertib remained low at 2.5%.

What are the FDA review plans and NDA timeline for IDEAYA’s darovasertib (IDYA)?

The FDA agreed to review the NDA for darovasertib plus crizotinib under the RTOR program. According to IDEAYA, the first pre-submission was completed in May 2026, and the company expects to complete the full NDA filing in the second half of 2026.