IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma

Rhea-AI Summary

IDEAYA (NASDAQ: IDYA) and Servier reported positive topline results from the Phase 2/3 OptimUM-02 trial of darovasertib plus crizotinib in first-line HLA-A*02:01-negative metastatic uveal melanoma. The combination improved median PFS to 6.9 months vs 3.1 months (HR 0.42; 95% CI 0.30-0.59; p<0.0001) and ORR to 37.1% vs 5.8% (p<0.0001), including five complete responses. Median DOR was 6.8 months. Safety was manageable with known adverse events; serious treatment-related events were single-digit percent. An NDA submission is planned for H2 2026 and full data will be presented at a major 2026 medical conference.

AI-generated analysis. Not financial advice.

Positive

• PFS improved to 6.9 months (darovasertib combo) vs 3.1 months (ICT)
• Risk reduction in progression: Hazard Ratio 0.42 (58% reduction)
• ORR increased to 37.1% versus 5.8% in ICT; includes 5 complete responses
• NDA planned for H2 2026 to support U.S. accelerated approval filing

Negative

• Duration of response median only 6.8 months
• Overall survival data immature; only an early trend reported
• Grade 3+ AEs included diarrhea, syncope, and hypotension

News Market Reaction – IDYA

+7.61%

16 alerts

+7.61% News Effect

+24.2% Peak Tracked

-15.0% Trough Tracked

+$195M Valuation Impact

$2.76B Market Cap

0.2x Rel. Volume

On the day this news was published, IDYA gained 7.61%, reflecting a notable positive market reaction. Argus tracked a peak move of +24.2% during that session. Argus tracked a trough of -15.0% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $195M to the company's valuation, bringing the market cap to $2.76B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Median PFS (combo): 6.9 months Median PFS (ICT): 3.1 months Hazard Ratio: 0.42 (95% CI: 0.30–0.59) +5 more

8 metrics

Median PFS (combo) 6.9 months Darovasertib + crizotinib arm by BICR in OptimUM-02

Median PFS (ICT) 3.1 months Investigator choice of therapy arm by BICR in OptimUM-02

Hazard Ratio 0.42 (95% CI: 0.30–0.59) Risk of progression vs ICT for PFS; p-value <0.0001

ORR (combo vs ICT) 37.1% vs 5.8% Overall response rate by BICR; p-value <0.0001

Complete responses 5 CRs Complete responses in darovasertib combination arm; none in ICT arm

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

Patients enrolled 313 patients Total enrolled in Phase 2b/3 portion of OptimUM-02

Arm sizes 210 vs 103 patients Darovasertib combination arm vs ICT arm in OptimUM-02

Market Reality Check

Price: $29.65 Vol: Volume 1,037,500 vs 1,075...

normal vol

$29.65 Last Close

Volume Volume 1,037,500 vs 1,075,796 20-day average (relative volume 0.96) ahead of this news. normal

Technical Shares at $30.50, trading slightly above 200-day MA of $29.71 and 22.35% below the $39.28 52-week high.

Peers on Argus

Momentum scanner flagged mixed peer action: TVTX up 5.84% and ARQT down 5.47%. B...

1 Up 1 Down

Momentum scanner flagged mixed peer action: TVTX up 5.84% and ARQT down 5.47%. Broader biotech peers (DNLI, GLPG, BLTE, TVTX) mostly showed negative or flat moves, indicating this registrational readout is stock-specific rather than a coordinated sector move.

Previous Clinical trial Reports

5 past events · Latest: Apr 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 06	Phase 1 trial start	Positive	-1.2%	First‑patient‑in for IDE574 Phase 1 dose‑escalation trial in solid tumors.
Mar 30	Combo Phase 1 start	Positive	+3.3%	First‑patient‑in for Phase 1 combo study of IDE849 and IDE161 in DLL3 tumors.
Mar 09	Phase 1 trial start	Positive	+5.7%	First‑patient‑in for IDE892 Phase 1 trial and MTAP/CDKN2A pipeline update.
Feb 27	Partner trial milestone	Positive	+2.6%	First patient dosed in Phase 1 trial of IDE034, triggering $5M milestone.
Feb 25	Phase 1 trial start	Positive	-1.3%	First‑patient‑in for IDE034 Phase 1 bispecific TOP1 ADC trial.

Pattern Detected

Recent clinical trial announcements typically led to modest positive moves, but there are instances where positive early-stage data coincided with short-term price declines.

Recent Company History

Over the last few months, IDEAYA has consistently reported clinical milestones across its pipeline, including first‑patient‑in updates for IDE034, IDE892, IDE849, and IDE574. These 5 tagged clinical‑trial events produced an average move of about 1.82%, with three aligned positively and two negative despite constructive news. Today’s positive Phase 2/3 topline darovasertib data builds on that trajectory, marking a shift from early Phase 1 starts toward registrational‑stage results in metastatic uveal melanoma.

Historical Comparison

+1.8% avg move · In the past 6 months, IDEAYA reported 5 clinical‑trial milestones averaging a 1.82% move. Those were...

clinical trial

+1.8%

Average Historical Move clinical trial

In the past 6 months, IDEAYA reported 5 clinical‑trial milestones averaging a 1.82% move. Those were mainly early Phase 1 starts, while today’s OptimUM‑02 readout delivers registrational Phase 2/3 efficacy data in metastatic uveal melanoma, representing a step‑change in maturity of the pipeline news flow.

Clinical news flow progressed from multiple first‑patient‑in Phase 1 trials (IDE034, IDE892, IDE849, IDE574) and partner milestones to registrational Phase 2/3 topline results for darovasertib in first‑line metastatic uveal melanoma.

Market Pulse Summary

The stock moved +7.6% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +7.6% in the session following this news. A strong positive reaction aligns with the clearly favorable OptimUM‑02 data, where median PFS reached 6.9 months versus 3.1 months on ICT and ORR was 37.1% versus 5.8%. Historically, IDEAYA’s clinical updates averaged about 1.82% moves, so a large gain could mark an outlier. Investors would need to weigh that against potential volatility, prior mixed reactions to good news, and the long runway to the planned H2 2026 NDA submission.

Key Terms

progression-free survival, overall response rate, duration of response, blinded independent central review, +4 more

8 terms

progression-free survival medical

"statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice"

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 response rate medical

"The secondary endpoints in the study include overall response rate (ORR) and duration of response (DOR)."

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.

duration of response medical

"The secondary endpoints in the study include overall response rate (ORR) and duration of response (DOR)."

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

blinded independent central review medical

"as assessed by blinded independent central review (BICR). The secondary endpoints in the study include"

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.

overall survival medical

"Darovasertib combination showed an early trend in improvement for OS versus ICT"

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.

HLA-A*02:01 medical

"first-line (1L) HLA-A*02:01-negative metastatic uveal melanoma (mUM). The darovasertib combination"

HLA-A*02:01 is a specific genetic variant of the human leukocyte antigen A protein, a display molecule on cells that helps the immune system recognize foreign bits of protein. For investors this matters because many vaccines, cancer immunotherapies, and diagnostic tests work only or best in people with particular HLA types; knowing how common this variant is and whether a therapy targets it affects clinical trial design, patient market size, and commercial prospects.

New Drug Application regulatory

"NDA submission planned for H2'26 to support U.S. accelerated approval filing."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

treatment emergent adverse events medical

"The most common Grade 3+ treatment emergent adverse events included diarrhea, syncope, and hypotension."

Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.

AI-generated analysis. Not financial advice.

• Trial met the primary endpoint showing statistically significant improvement in median PFS by BICR, with 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001)
• Secondary endpoint of ORR by BICR was 37.1% for the darovasertib combination versus 5.8% for ICT (p-value: <0.0001), including 5 complete responses in the darovasertib combination arm
• Darovasertib combination showed an early trend in improvement for OS versus ICT
• Well-tolerated, with manageable safety profile consistent with previously reported AEs
• NDA submission planned for H2'26 to support U.S. accelerated approval filing. Full data from OptimUM-02 to be presented at major medical conference in 2026
• IDEAYA to host webcast today at 8:00 AM ET to discuss study results and next steps

SOUTH SAN FRANCISCO, Calif., April 13, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, and Servier, an independent international pharmaceutical group governed by a foundation, today announced positive topline results from their Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib (darovasertib combination) in patients with first-line (1L) HLA-A*A2:01-negative metastatic uveal melanoma (mUM). The darovasertib combination met the trial's primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). The secondary endpoints in the study include overall response rate (ORR) and duration of response (DOR). 

"OptimUM-02 is the first randomized study to demonstrate a statistically significant and clinically meaningful benefit in PFS in the clinical setting of first-line HLA-A*02:01-negative metastatic uveal melanoma. For patients with uveal melanoma, these results potentially offer a new treatment option that delivers a significant clinical advancement in both PFS and ORR versus currently available therapies," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"This is a very encouraging milestone demonstrating the potential of this combination in the first-line treatment landscape for patients with metastatic uveal melanoma. Our collaboration with IDEAYA reflects a shared commitment to advancing research and bringing a potential first-in-class treatment to patients," said Claude Bertrand, Executive Vice President Research and Development, Servier.

"Metastatic uveal melanoma is an area of high unmet medical need with poor prognosis and short overall survival, and there are currently no approved therapies for HLA-A*02:01-negative mUM patients. The data from the OptimUM-02 study provides potential practice changing results for the treatment of first-line metastatic uveal melanoma," said Dr. Meredith McKean, Sarah Cannon Research Institute.

OptimUM-02 Study Highlights

OptimUM-02 is a global, randomized Phase 2/3 trial in 1L HLA-A*A2:01-negative MUM evaluating darovasertib combination arm of 210 patients versus the ICT arm reflective of real-world clinical practice that consists of 103 patients. The ICT arm was composed of 76% (n=78) ipilimumab plus nivolumab (anti-CTLA-4/PD-1) and 24% (n=25) pembrolizumab (anti-PD-1). The primary endpoint is median PFS as assessed by BICR, which will be used to support an initial NDA submission in the United States. Topline results were from a total of 313 patients enrolled in the Phase 2b/3 portion of the trial as of the cut-off date of January 23, 2026. The PFS analysis was based on a total of 159 events.

Patients treated with the darovasertib combination reduced their risk of disease progression as assessed by BICR by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieved a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm. The overall response rate (ORR) by BICR in the darovasertib combination and ICT arm was 37.1% and 5.8% (p-value: <0.0001), respectively. There were 5 complete responses by BICR observed in the darovasertib combination arm, and no complete responses observed in the ICT arm. The median duration of response (DOR) in the darovasertib combination arm was 6.8 months.

The overall survival (OS) data is not mature. However, in the OptimUM-02 study, there is an early trend in improvement in OS with the darovasertib combination arm versus the ICT arm.

Darovasertib combination was generally well-tolerated with a manageable safety profile consistent with prior reported results and known side-effects of each drug. The most common Grade 3+ treatment emergent adverse events included diarrhea, syncope, and hypotension. The treatment-related serious adverse events rate in the darovasertib combination was in the single-digit percent range.

Based on these data, the company will target to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026. IDEAYA plans to provide additional details from OptimUM-02 at a major medical conference in 2026.

Conference Call and Q&A Webcast Information

Members of IDEAYA's management and distinguished key opinion leader Dr. Meredith McKean, M.D., MPH, Sarah Cannon Research Institute, will host a conference call and live question and answer (Q&A) webcast for covering research analysts to discuss the study results and next steps today, April 13, 2026, at 8:00 AM ET. The IDEAYA management participants will be Yujiro Hata, Chief Executive Officer and President, Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, and Joshua Bleharski, Ph.D., Chief Financial Officer. The webcast can be accessed using this link or by visiting the Events section of the IDEAYA website (please allow time for registration). A replay will be available on the company's website for 30 days following the live event.

About Uveal Melanoma

Uveal melanoma (UM) is a rare, aggressive form of ocular cancer in which approximately 95% of patients have activating mutations in GNAQ/11 GTPase proteins that drive downstream PKC signaling and tumor growth. The annual incidence of primary UM is >10,000 patients globally (including North America, Europe and Australia) and >3,000 patients in the United States, with approximately 50% of patients progressing to metastatic disease (mUM). We estimate the majority (50-70%) of mUM patients are of the HLA-A*02:01-negative serotype. Currently, there are no FDA-approved systemic therapies for primary UM and no FDA-approved therapies for patients with HLA-A*02:01-negative mUM.

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/ 

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 deliver 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

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Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the clinical significance and potential therapeutic benefit of darovasertib in combination with crizotinib; the interpretation of the topline results from the OptimUM-02 trial; the potential for the combination to become a new standard of care for first-line HLA-A*02:01-negative metastatic uveal melanoma; the sufficiency of the trial results to support regulatory submissions; the preliminary trends in overall survival data; the safety and tolerability profile of darovasertib combination; the timing and plans for submission of a New Drug Application (NDA) in the second half of 2026; the potential for accelerated approval in the United States; the timing and content of future data presentations; the development, regulatory and commercial plans for darovasertib; and the potential market opportunity for the combination therapy. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially 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 the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of 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, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed on February 17, 2026 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

Servier Service presse Presse@servier.com

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What were the topline PFS results for IDEAYA (IDYA) darovasertib plus crizotinib in OptimUM-02?

The darovasertib combination achieved median PFS of 6.9 months versus 3.1 months for ICT. According to the company, BICR-assessed analysis showed a Hazard Ratio of 0.42 (95% CI 0.30-0.59; p<0.0001), a 58% reduction in progression risk.

How did the overall response rate (ORR) compare between the darovasertib combo and ICT in OptimUM-02 (IDYA)?

ORR was markedly higher with the darovasertib combination at 37.1% versus 5.8% for ICT. According to the company, this BICR-assessed difference was statistically significant (p<0.0001) and included five complete responses in the combo arm.

Is IDEAYA planning an NDA submission for darovasertib (IDYA) after OptimUM-02 results?

Yes — IDEAYA plans to target an NDA submission in H2 2026 to support a U.S. accelerated approval filing. According to the company, median PFS and ORR from OptimUM-02 will be used to support the initial submission.

What safety signals did IDEAYA report for darovasertib plus crizotinib in OptimUM-02 (IDYA)?

The combination was generally well-tolerated with a manageable safety profile, though Grade 3+ events included diarrhea, syncope, and hypotension. According to the company, treatment-related serious adverse events occurred in the single-digit percent range.

How mature are the overall survival (OS) results from OptimUM-02 for IDEAYA (IDYA)?

OS data are not mature; only an early trend toward improvement was observed with the combo. According to the company, longer follow-up is required before definitive OS conclusions can be drawn or used for regulatory decisions.

How large was the randomized population in OptimUM-02 that supports IDEAYA's (IDYA) topline results?

Topline results came from 313 patients in the Phase 2b/3 portion with a PFS analysis based on 159 events. According to the company, the randomized arms included 210 patients in the darovasertib combination and 103 in the ICT arm.