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Darovasertib combo boosts PFS in IDEAYA (NASDAQ: IDYA) uveal melanoma trial

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

IDEAYA Biosciences reported strong positive Phase 2/3 data for darovasertib plus crizotinib in first-line metastatic uveal melanoma. In 313 patients, the combination cut the risk of disease progression by 58% versus investigator’s choice therapy, with a hazard ratio of 0.42 and p<0.0001.

Median progression-free survival was 6.9 months on the combination versus 3.1 months on standard regimens, and overall response rate was 37.1% versus 5.8%. Five complete responses were seen on the combination and none in the control arm. Safety was generally manageable, and IDEAYA plans to submit a U.S. NDA in the second half of 2026.

Positive

  • Compelling efficacy versus standard of care: The darovasertib plus crizotinib combination cut progression risk by 58%, doubled median PFS to 6.9 vs 3.1 months, and delivered a 37.1% response rate vs 5.8%, providing a strong foundation for a planned NDA in 2H 2026.

Negative

  • Key data still maturing and regulatory risk remains: Overall survival data are not yet mature, and approval is not guaranteed. Future FDA decisions, safety assessment, and evolving treatment standards will determine the ultimate clinical and commercial impact.

Insights

Pivotal uveal melanoma data show strong efficacy and support an NDA in 2H 2026.

The Phase 2/3 trial in first-line HLA-A*A2:01-negative metastatic uveal melanoma showed the darovasertib plus crizotinib combination reduced risk of progression by 58% versus standard immunotherapy, with a hazard ratio of 0.42 and p<0.0001. Median progression-free survival improved to 6.9 months from 3.1 months.

Response metrics were also compelling: overall response rate by blinded independent central review was 37.1% on the combination versus 5.8% on control, including five complete responses, with a median duration of response of 6.8 months. The safety profile was described as generally well-tolerated, with Grade 3+ diarrhea, syncope, and hypotension as key events and a single-digit serious adverse event rate.

These data provide a strong efficacy and safety package for regulatory review and will be used to support a New Drug Application in the United States in the second half of 2026. Overall survival data are still immature, and ultimate regulatory outcomes and commercial performance will depend on future FDA decisions and competitive dynamics.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Trial enrollment 313 patients Phase 2b/3 portion as of January 23, 2026
Randomization arms 210 vs 103 patients Darovasertib combo arm vs investigator’s choice arm
Median PFS improvement 6.9 vs 3.1 months Darovasertib combination vs investigator’s choice therapy
Progression risk reduction Hazard Ratio 0.42 58% reduction in risk of progression by BICR
Overall response rate 37.1% vs 5.8% Darovasertib combination vs investigator’s choice by BICR
Median duration of response 6.8 months Darovasertib combination arm
PFS events at analysis 159 events Number of PFS events for primary endpoint analysis
registrational trial medical
"announced clinical data from the Company’s Phase 2/3 registrational trial"
A registrational trial is the large, definitive clinical study designed to provide the evidence regulators need to decide whether a new drug or medical product can be approved for sale. Think of it as the final exam for a treatment: passing it can unlock widespread market access and potential revenues, while failing it can sharply reduce a product’s commercial prospects and raise investment risk.
median progression-free survival medical
"primary endpoint of a statistically significant improvement in median progression-free survival"
Median progression-free survival is the length of time at which half of patients in a clinical study have not experienced disease worsening or progression. Think of it like the moment in a race when 50% of runners have not yet crossed a trouble line—it shows how long a therapy can delay disease activity for a typical patient. Investors use it as a straightforward signal of a drug’s effectiveness that can influence regulatory approval, market demand, and revenue potential.
blinded independent central review medical
"as assessed by blinded independent central review"
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 response rate medical
"The secondary endpoints in the study include overall response rate"
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 and duration of response"
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.
New Drug Application regulatory
"used to support an initial New Drug Application ("NDA") submission"
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.
Understanding 8-K Material Events →
false 0001676725 0001676725 2026-04-13 2026-04-13
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 13, 2026

 

 

IDEAYA Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38915   47-4268251

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

5000 Shoreline Court, Suite 300

South San Francisco, California 94080

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 443-6209

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  ☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading

Symbol

  

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   IDYA   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 

Item 8.01

Other Information.

Clinical Update

On April 13, 2026, IDEAYA Biosciences, Inc. (the “Company”) and Servier, an independent international pharmaceutical group governed by a foundation, announced clinical data from the Company’s 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”). The 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.

OptimUM-02 is a global, randomized Phase 2/3 trial in 1L HLA-A*A2:01-negative MUM evaluating the 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 New Drug Application (“NDA”) submission in the United States.

The Company reported that 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 Company also reported that 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 DOR in the darovasertib combination arm was 6.8 months. The overall survival (“OS”) data is not mature. However, the Company observed that, in the OptimUM-02 study, there is an early trend in improvement in OS with the darovasertib combination arm versus the ICT arm. The 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 an NDA to the U.S. Food and Drug Administration (“FDA”) in the second half of 2026. The Company plans to provide additional details from OptimUM-02 at a major medical conference in 2026.

Forward-Looking Statements

Certain statements contained herein are 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.

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  IDEAYA BIOSCIENCES, INC.
Date: April 13, 2026   By:  

/s/ Yujiro Hata

    Yujiro Hata
    President and Chief Executive Officer

Source: View Original Filing on SEC EDGAR

FAQ

What did IDEAYA (IDYA) announce about its darovasertib Phase 2/3 trial?

IDEAYA reported positive topline results from a Phase 2/3 registrational trial of darovasertib plus crizotinib in first-line metastatic uveal melanoma. The combo significantly improved progression-free survival and response rates versus standard therapies, with data intended to support a planned U.S. NDA submission.

How much did IDEAYA’s darovasertib combination improve progression-free survival?

The darovasertib plus crizotinib combination achieved median progression-free survival of 6.9 months versus 3.1 months for investigator’s choice therapy. This corresponded to a 58% reduction in risk of disease progression, with a hazard ratio of 0.42 and highly significant p-value below 0.0001.

What were the response rates in IDEAYA (IDYA)’s metastatic uveal melanoma trial?

Overall response rate by blinded independent central review was 37.1% for darovasertib plus crizotinib, versus 5.8% for the control arm. Five complete responses occurred on the combination, while no complete responses were reported in patients receiving the investigator’s choice therapies.

How many patients were included in IDEAYA’s Phase 2/3 darovasertib study?

The Phase 2/3 registrational trial enrolled 313 patients as of the January 23, 2026 cutoff. The randomized design compared 210 patients on the darovasertib plus crizotinib combination with 103 patients receiving investigator’s choice immunotherapy regimens reflecting real-world clinical practice.

What safety profile was reported for IDEAYA’s darovasertib combination therapy?

The company described the darovasertib plus crizotinib regimen as generally well-tolerated, with a manageable safety profile consistent with prior results and known drug side-effects. Common Grade 3 or higher treatment-emergent adverse events included diarrhea, syncope, and hypotension, with serious adverse events in the single-digit percent range.

When does IDEAYA (IDYA) plan to submit a New Drug Application for darovasertib?

IDEAYA plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2026. The NDA will be supported by this Phase 2/3 trial’s progression-free survival data and other efficacy and safety results in metastatic uveal melanoma.

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