IDE-892

Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint; complete data will be provided in a late-breaking oral presentation at ASCO IDEAYA to initiate RTOR submission process with first pre-submission in May; targeting completion of the NDA filing in H2 2026 Clinical updates from Phase 2 OptimUM-01 trial in HLA*A2-positive mUM, Phase 2 OptimUM-09 in neoadjuvant primary UM and Phase 1/2 trials with IDE849 (DLL3 TOP1 ADC) and IDE034 (B7H3/PTK7 bispecific TOP1 ADC) planned for H2 2026 Initiation of registrational trial for IDE849 monotherapy in DLL3-positive solid tumors planned by year-end 2026; Phase 1 combination cohort of IDE892 (PRMT5) + IDE397 (MAT2A) in MTAP-deleted cancers to begin in mid-2026 ~$973 million of cash, cash equivalents, and marketable securities as of March 31, 2026; current cash runway guidance into 2030 remains unchanged SOUTH SAN FRANCISCO, Calif., May 5, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the first quarter ended March 31, 2026. "This was a transformational quarter for IDEAYA, with positive topline results from the OptimUM-02 registrational trial in first line HLA*A2-negative metastatic uveal melanoma to enable the company's first NDA submission for potential U.S. accelerated approval. We look forward to a catalyst rich second half of 2026, including targeted clinical data updates for the darovasertib combination in HLA*A2-positive mUM, IDE849 in DLL3-positive solid tumors, and IDE034, our potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, in multiple large solid tumor indications. Finally, clinical dose escalation is advancing rapidly for our potential first-in-class KAT6/7 dual inhibitor, IDE574, and our PRMT5 inhibitor, IDE892, with the goal of initiating clinical expansion and combination trials with IDE892 in MTAP-deleted PDAC and NSCLC in the second half of this year," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Pipeline Developments and Corporate Updates Darovasertib in Uveal Melanoma On April 13th IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2-negative metastatic uveal melanoma (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. IDEAYA will provide complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois, and plans to submit a manuscript for publication in the second half of 2026. A new drug application (NDA) submission to the U.S. Food and Drug Association (FDA) is planned in the second half of 2026 to support a potential U.S. accelerated approval. The FDA has agreed to review IDEAYA's NDA under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program, which allows an applicant to pre-submit components of its NDA for review before the complete filing is submitted to provide a more efficient review process and ensure safe and effective treatments are available to patients as early as possible. IDEAYA has completed enrollment of approximately 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib. The company plans to present data at a major medical conference from over 85 efficacy-evaluable HLA*A2-positive mUM patients in the second half of 2026. Data will include updated ORR, PFS, and OS results, which will be used to support a potential regulatory submission to the FDA to expand the labeled use of darovasertib and/or guideline inclusion to enable the use of the darovasertib combination in HLA*A2-positive mUM patients. In collaboration with Servier, IDEAYA successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial evaluating darovasertib in combination with crizotinib in the adjuvant setting of primary uveal melanoma. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment with darovasertib combined with crizotinib for 12-months or observation. The primary endpoint is superiority by relapse-free survival (RFS). OptimUM-11 is a global trial being conducted as part of IDEAYA's partnership with Servier and is expected to initiate in the first half of 2026. IDEAYA is continuing site activation and patient enrollment in the Phase 3 OptimUM-10 trial of neoadjuvant darovasertib in primary uveal melanoma. Full enrollment in the trial is estimated to be complete by the end of 2027, revised from prior guidance of first half of 2027. IDEAYA is targeting to provide a clinical data update from the ongoing Phase 2 OptimUM-09 trial at a medical conference in the second half of 2026. ADC / DDR combinations IDE849 (DLL3 TOP1 ADC): targeting to provide a clinical data update from the ongoing IDEAYA-sponsored global Phase 1/2 trial of IDE849 in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) by the end of 2026. The company is planning to initiate a monotherapy registrational trial by the end of 2026. In April, IDEAYA entered into a clinical collaboration agreement with AstraZeneca plc to evaluate the efficacy and safety of IDE849 in combination with Imfinzi® (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, in extensive-stage SCLC. IDEAYA will sponsor the clinical combination trial; AstraZeneca will supply Imfinzi® at no cost. Achieved first-patient-in (FPI) in Phase 1 combination trial of IDE849 and IDE161, IDEAYA's proprietary inhibitor of poly(ADP-ribose) glycohydrolase (PARG). Data from this trial are intended to help evaluate the potential synergy between TOP1 and PARG inhibition to drive deeper, more durable anti-tumor responses in patients IDEAYA's China-region partner, Jinagsu Hengrui Pharmaceuticals Co. Ltd., is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and provide a clinical update from their Phase 1 trial in SCLC and NEC at a medical conference in the second half of 2026. IDE034 (B7H3/PTK7 bispecific TOP1 ADC): achieved FPI in Phase 1 dose escalation trial to evaluate IDE034 in solid tumors, and is targeting to provide a clinical data update by the end of 2026. IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats. Patient dosing triggered a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies. MTAP pathway IDE892 (PRMT5): achieved FPI in Phase 1 dose escalation trial of IDE892 in MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDEAYA is planning to initiate a Phase 1 combination cohort with IDE397, its proprietary MAT2A inhibitor, in MTAP-deleted cancers in mid-2026 and expansion in the second half of 2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC. In March, IDEAYA announced it will deprioritize clinical activity with Gilead evaluating the combination of IDE397 and Trodelvy and conclude enrollment in the Phase 1/2 trial in MTAP-deleted urothelial and lung cancers. Other programs IDE574 (KAT6/7): achieved FPI in Phase 1 dose escalation trial of IDE574 in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation. Following termination of the Collaboration, Option and License Agreement with GlaxoSmithKline in 2025, IDEAYA plans to discontinue development of IDE275, a small molecule inhibitor of Werner helicase (WRN), and IDE705, a small molecule inhibitor of Pol-Theta helicase (POLQ). The company is currently evaluating strategic options for these assets. Corporate In February, IDEAYA announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. Dr. Ross will be responsible for leading early clinical development for IDEAYA's emerging oncology pipeline and play a crucial role in guiding the company's long-term R&D strategy. She joins IDEAYA from AbbVie, where she served as Vice President, Head of Early Oncology R&D and Site Head for the Bay Area. As of March 31, 2026, IDEAYA had $972.9 million of cash, cash equivalents and marketable securities; current cash runway guidance into 2030 remains unchanged. Financial Results for the Quarter Ended March 31, 2026 As of March 31, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $972.9 million, compared to $1.05 billion as of December 31, 2025. The decrease was primarily driven by net cash used in operations. Collaboration revenue for the three months ended March 31, 2026, totaled $6.6 million compared to $10.9 million for the three months ended December 31, 2025. Collaboration revenue was recognized for the performance obligations satisfied through March 31, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of March 31, 2026, the remaining balance for the research and development services performance obligations is $155.3 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed. Research and development (R&D) expenses for the three months ended March 31, 2026 totaled $95.7 million compared to $86.6 million for the three months ended December 31, 2025. The increase was primarily driven by higher clinical trial and personnel-related expenses to support our programs. General and administrative (G&A) expenses for the three months ended March 31, 2026 totaled $19.4 million compared to $18.8 million for the three months ended December 31, 2025. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities. The net loss for the three months ended March 31, 2026, was $98.5 million compared to the net loss of $83.3 million for the three months ended December 31, 2025. Total stock compensation expense for the three months ended March 31, 2026, was $14.5 million compared to $11.8 million for the three months ended December 31, 2025. 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: . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding IDEAYA Biosciences, Inc.'s ("IDEAYA") expectations with respect to the timing, progress, and results of its clinical trials and preclinical programs; the potential safety, efficacy, and therapeutic benefits of its product candidates; the planned presentation and publication of clinical data; the timing and likelihood of regulatory submissions, including the planned new drug application (NDA) for darovasertib and participation in the FDA's Real-Time Oncology Review (RTOR) program; the potential for accelerated approval and label expansion; the initiation, design, and enrollment of current and future clinical trials; the development and advancement of IDEAYA's pipeline programs, including IDE849, IDE034, IDE892, IDE397, and IDE574; the expected timing of clinical updates and milestones; the potential benefits of collaborations; and IDEAYA's financial position, including its expected cash runway. These forward-looking statements are based on management's current expectations and assumptions and are subject to a number of risks, uncertainties, and other factors 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, progress, and results of clinical trials and preclinical studies; the ability of IDEAYA to obtain and maintain regulatory approvals; uncertainties regarding the regulatory review process, including participation in the RTOR program; the potential for clinical data to differ from preliminary or interim results; the ability to successfully develop, manufacture, and commercialize product candidates; competition from other biotechnology and pharmaceutical companies; the impact of global economic conditions; 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 and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements speak only as of the date of this press release, 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 Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo

关注"肿瘤医谈"公众号，回复关键词即可获取：原文PDF 📌肿瘤医谈·导语 昨天我们聊了AACR 2026里最热的两条主线：KRAS进入2.0阶段，以及双靶ADC开始从概念走向系统化竞争。但如果只盯着最热的赛道，反而容易错过真正有“下一阶段含金量”的东西。因为AACR这种会，很多时候最重要的不是“哪个靶点最火”，而是哪个方向正在悄悄改变大家定义好药的标准。 今天看下来，我觉得有三条线特别值得继续盯：CLDN18.2的多模态升级、合成致死2.0，以及肿瘤微环境/基质靶点的前移。  内容解读  一、CLDN18.2还没到终局，但竞争逻辑已经完全变了 AACR 2026官方议程专门设置了Claudin-Targeted Therapies相关内容，这本身就是一个信号：CLDN18.2已经不再只是“一个热门胃癌靶点”，而是变成了一个会持续演化的平台级方向。  更关键的是，这个靶点现在卷的早就不是“谁先上临床”，而是“谁能把疗效、安全性和适用场景重新做平衡”。Xilio将在AACR 2026展示XTX601，这是一款masked CLDN18.2-targeting T cell engager。简单理解，它想做的不是更猛，而是更局部、更受控地激活T细胞杀伤，尽量把系统性毒性关在肿瘤外面。这个思路很有代表性：CLDN18.2进入下一阶段后，大家不再只比命中率，而是在比谁更会管理毒性窗口。  Phanes披露的spevatamig则是另一条非常值得关注的路线。它是一个CLDN18.2×CD47双抗，而且这次AACR会展示围绕药代、安全性和血液学毒性处理的临床研究内容。为什么这条线有意思？因为它在试图回答CD47赛道一个长期难题：怎样把免疫激活保留下来，又把“血液学代价”降下来。 如果CLDN18.2能与CD47、TCE、masking、肿瘤限制性激活这些设计持续结合，它就不只是一个热门靶点，而会成为一个真正的“多模态竞技场”。  所以，CLDN18.2的下一阶段竞争，本质上已经变成三句话：谁能拓展肿瘤类型，谁能改善耐受性，谁能把单一靶点做成平台。 这比单纯再做一个“CLDN18.2新分子”重要得多。 二、合成致死进入2.0： 不只是PARP，而是“肿瘤依赖性脆弱点”的扩容 AACR 2026议程里，Synthetic Lethality in Oncology和DNA Damage Response and Synthetic Lethality in Cancer被放到了相当重要的位置。这说明一件事：行业现在看“新靶点”，已经越来越不满足于经典驱动基因，而是开始系统性寻找肿瘤在特定遗传背景下才暴露出来的脆弱性。 IDEAYA这次披露的两个项目就很典型。IDE892是一款针对MTAP缺失肿瘤的MTA-cooperative PRMT5 inhibitor，并明确提出和MAT2A抑制剂IDE397联合开发的方向；而IDE574则瞄准KAT6/7，希望通过干扰肿瘤谱系身份和耐药耐受状态来实现治疗增益。翻译成更直白的话就是：精准治疗正在从“你有这个突变，我来堵这个蛋白”，进化到“你因为失去了某个功能，形成了新的生存依赖，那我就切断这条依赖”。  这类项目的价值，未必在于一上来就成为最大适应证，而在于它们特别有可能重塑分层逻辑。如果后续数据成熟，PRMT5/MAT2A、KAT6/7这类方向很可能会让“精准肿瘤学”从单一驱动事件匹配，走向更精细的“遗传背景—代谢状态—表观调控”联合分层。对药企来说，这类药可能不是最容易讲故事的，但很可能是最容易建立壁垒的。 三、肿瘤微环境和基质，正在从背景板变成真正的前线靶点 这一届AACR还有一条非常清晰但容易被低估的信号：“好靶点”不再只等于肿瘤细胞上的高表达分子。 越来越多项目开始把视角转向CAF、基质、肿瘤特异微环境、正常组织低表达但肿瘤相关性强的胚胎/发育相关抗原。  Zai Lab披露的ZL-6201就是很典型的例子。它靶向LRRC15，不仅覆盖部分间叶来源肿瘤，也瞄准多种实体瘤中的LRRC15阳性癌相关成纤维细胞（CAFs）；与此同时，ZL-1222则把PD-1和衰减型IL-12做成一体，目标是在增强抗肿瘤免疫的同时，避免传统IL-12策略的系统毒性问题。这里最值得记住的不是单个项目，而是一个方法论变化：未来能成的药，可能不只是“打肿瘤细胞”，而是“重写肿瘤生态位”。  Antengene这次披露的ATG-106（CDH6×CD3）和ATG-112（ALPPL2×CD3），也都沿着同一个方向在走。它们强调的是：正常成人组织低表达、肿瘤中高表达、并且通过结构设计尽量把T细胞激活限制在肿瘤环境里。 这种设计思路之所以越来越重要，就是因为实体瘤TCE能否真正走出来，核心从来不是“能不能杀伤”，而是“能不能在真实人体里安全地杀伤”。  CStone的CS5006则代表了另一类正在升温的方向：ITGB4这类过去更多出现在黏附、侵袭和发育研究中的分子，正在被重新评估为具备成药潜力的实体瘤靶点。公开资料提到，ITGB4在多种肿瘤中高表达、而在正常组织中相对有限，这类“差异表达+较好窗口”的组合，未来很可能会成为ADC和其他递送类药物继续扩容的重要来源。 三、肿瘤微环境和基质，正在从背景板变成真正的前线靶点四、AACR 2026之后，真正值得追的，是“靶点—机制—人群—安全性”的闭环 如果一定要给AACR 2026目前的靶点风向做个总结：肿瘤新药研发正在从“找到一个靶点”升级到“设计一整套作战系统”。 CLDN18.2在走向多模态，合成致死在走向背景依赖性分层，微环境/基质靶点在走向前台，而这一切最后都会回到同一个问题：谁能同时把机制成立、患者筛选和安全窗口做好。  对于临床端，这意味着未来治疗选择会更依赖机制和分层；对于研发端，这意味着“靶点新”已经不够，真正稀缺的是靶点与modalities的匹配能力；对于内容端来说，AACR 2026也给了我们一个很清晰的判断：接下来真正值得长期跟的，未必是最吵的靶点，而是那些能把疗效、毒性和分层同时往前推一步的项目。 参考资料 [1]American Association for Cancer Research. AACR Annual Meeting 2026: Program [EB/OL].  [2]Xilio Therapeutics. Xilio Therapeutics to Present New Preclinical Data for its Masked T Cell Engager Program Targeting CLDN18.2 at AACR 2026 [EB/OL].  [3]Phanes Therapeutics. Phanes Therapeutics to Present Three Clinical Posters at AACR 2026 [EB/OL].  [4]IDEAYA Biosciences. IDEAYA Biosciences Announces Upcoming Presentations at AACR 2026 Highlighting Multiple Clinical Stage Pipeline Programs [EB/OL]. [5]Zai Lab. Zai Lab to Present New Data on Three Internally Developed Oncology Candidates at AACR 2026 [EB/OL].  [6]Antengene. Antengene to Present on Three Preclinical Programs at AACR 2026 Highlighting Next-Generation ADCs and AnTenGager TCEs [EB/OL].  [7]CStone Pharmaceuticals. AACR 2026 Preview: CStone to Present Preclinical Data for Three Proprietary Programs [EB/OL]. 关注"肿瘤医谈"公众号，回复关键词即可获取：原文PDF 关于肿瘤医谈 肿瘤医谈致力于传播前沿肿瘤研究，解读重磅文献，为临床医生和患者提供有价值的医学资讯。