This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

开始日期2026-01-25

申办/合作机构

IDEAYA Biosciences, Inc.

NCT05987332

/ Active, not recruiting临床2/3期

IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

开始日期2023-10-31

申办/合作机构

IDEAYA Biosciences, Inc.

NCT05907954

/ Recruiting临床2期

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

开始日期2023-07-03

申办/合作机构

IDEAYA Biosciences, Inc.

100 项与 Darovasertib 相关的临床结果

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100 项与 Darovasertib 相关的转化医学

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100 项与 Darovasertib 相关的专利（医药）

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项与 Darovasertib 相关的文献（医药）

2025-10-01·JOURNAL OF BIOLOGICAL CHEMISTRY

Inhibition of anti-apoptotic BCL2 overcomes adaptive resistance to co-targeting of the protein kinase FAK and MEK in GNAQ-driven uveal melanoma

Article

作者: Lubrano, Simone ; Cuesta-Margolles, Gabriela ; Aplin, Andrew E ; Gutkind, J Silvio ; Officer, Adam ; Adame-Garcia, Sendi Rafael ; Arang, Nadia ; Cervantes-Villagrana, Rodolfo Daniel

Uveal melanoma (UVM) is the most common eye cancer in adults, with 50% of patients developing overt metastasis that often proves fatal. The majority of UVM harbor mutations in GNAQ or GNA11, encoding constitutively active Gαq proteins. Combined inhibition of MEK and FAK downstream of Gαq has shown promising effects in UVM cells by inducing apoptotic cell death, but resistance to this strategy can occur in the clinic. Here, we aimed to identify new targets to overcome resistance to MEK + FAK inhibition (FAKi + MEKi). Reverse-phase protein array (RPPA) analysis in UVM cells treated with FAKi + MEKi showed increased levels of pro-apoptotic proteins, such as PUMA and BIM, which promoted cell death. However, we observed an adaptive increase in anti-apoptotic proteins, including BCL2, upon FAK + MEK blockade. We generated UVM cells resistant to FAKi + MEKi by prolonged exposure. Whole-exome sequencing did not reveal relevant acquired mutations; instead, resistant cells exhibit increased BCL2 levels. Moreover, expression of a stable BCL2 mutant confers resistance to both FAKi + MEKi and FAKi+"RAF-MEK clamp" (avutometinib) treatment. Of direct translational relevance, we found that an approved BCL2 inhibitor (venetoclax) displays synergistic efficacy with FAK + MEK blockade and overcomes acquired resistance, including when combined with darovasertib, a dual PKC/PKN inhibitor limiting MEK and FAK signaling that is under clinical evaluation. Our findings suggest that resistance to FAKi + MEKi in UVM cells can be driven by an adaptive upregulation of the anti-apoptotic protein BCL2, and that, in turn, BCL2 inhibitors represent a promising precision-targeted strategy to overcome FAKi + MEKi treatment resistance and improve therapeutic outcomes.

2024-09-01·AMERICAN JOURNAL OF CLINICAL DERMATOLOGY

The Current State of Systemic Therapy of Metastatic Uveal Melanoma

Review

作者: Berking, Carola ; Koch, Elias A T ; Heppt, Markus V

Uveal melanoma (UM) is genetically a distinct tumor compared to cutaneous melanoma (CM), and due to its low mutational burden, it is far less perceptible to the immune system. Thus, treatments that have revolutionized the treatment of CM remain widely inefficient in metastatic UM or only demonstrate effectiveness in a small subpopulation of patients. To this end, the therapeutic benefit of immune checkpoint blockade is very limited and may come at the expense of severe immune-related adverse events that could potentially affect all organ systems. Notably, tebentafusp, an entirely novel class of anti-cancer drugs, has received official authorization for the treatment of metastatic UM. It is the first agent that demonstrated a survival advantage in a randomized controlled trial of metastatic UM patients. Despite the survival benefit and approval, the restriction of tebentafusp to HLA-A*02:01-positive patients and the low objective response rate indicate the persistent need for additional therapies. Thus, liver-directed therapies are commonly used for tumor control of hepatic metastases and represent a central pillar of the daily management of liver-dominant disease. Further, promising data from targeted therapies independent of MEK-inhibitors, such as the combination of darovasertib and crizotinib, raise hope for additional options in metastatic UM in the future. This narrative review provides a timely and comprehensive overview of the current treatment landscape for metastatic UM.

2024-04-01·Ophthalmology. Retina

Globe Salvage and Vision Preservation by Neoadjuvant Darovasertib and Crizotinib in Uveal Melanoma

Article

作者: Malaka Ameratunga ; Anthony M. Joshua ; Mark Shackleton ; Alison Hiong ; Roderick O’Day ; Daniel McKay ; Lotte S. Fog ; John McKenzie

PURPOSE:

To report the effective use of neoadjuvant darovasertib and crizotinib in a patient with a large uveal melanoma (UM) in his only functional eye.

DESIGN:

Case report.

SUBJECTS:

One patient with T4b UM.

INTERVENTION:

Neoadjuvant darovasertib and crizotinib, followed by plaque brachytherapy.

MAIN OUTCOME MEASURES:

Objective tumor response and conversion from planned enucleation to placement of fovea- and optic nerve-sparing plaque brachytherapy.

RESULTS:

A patient with a history of left eye blindness from retinal artery occlusion presented with rapidly declining right eye vision due to a primary UM measuring 18 mm in maximal diameter and 16.5 mm in maximal thickness. To salvage vision, neoadjuvant treatment was initiated using darovasertib and crizotinib. After 6 months of neoadjuvant treatment, which included intraocular lens replacement for tumor-associated cataract, the tumor regressed to 14.1 mm in maximal diameter and 2.6 mm in maximal thickness, enabling treatment with plaque brachytherapy rather than enucleation.

CONCLUSIONS:

The combination of darovasertib and crizotinib for UM is an effective neoadjuvant strategy that warrants further investigation as an approach to improve visual outcomes from the treatment of primary UM.

FINANCIAL DISCLOSURE:

The other authors have no proprietary or commercial interest in any materials discussed in this article.

项与 Darovasertib 相关的新闻（医药）

2026-03-06

·FierceBiotech

Servier to widen rare cancer offerings with $2.5B buyout of Day One and glioma drug Ojemda

The crown jewel of a transaction with Servier is no doubt Day One Biopharmaceuticals\' Ojemda (tovorafenib), a type 2 RAF inhibitor approved in 2024 to treat patients 6 months and older with relapsed or refractory pediatric low-grade glioma. \n As nonprofit-governed Servier continues to make gains with its IDH-mutant glioma med Voranigo, the drugmaker is wading deeper into the rare oncology arena with a new M&A play. Servier on Friday unveiled a definitive agreement to acquire Day One Biopharmaceuticals—a commercial-stage company developing targeted therapies for pediatric cancers and other diseases—for $21.50 per share in cash. The total value of the deal, which is expected to close in the second quarter, comes to roughly $2.5 billion, the companies said in a March 6 release. The crown jewel of the transaction is no doubt Day One’s Ojemda (tovorafenib), a type 2 RAF inhibitor approved by the FDA in April 2024 to treat patients ages 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG), a more advanced stage of the common childhood brain tumor. That drug will likely mesh well with Servier’s Voranigo, also approved in 2024 under a different glioma niche in patients 12 years and older with a susceptible IDH1 or IDH2 mutation. Servier acquired that drug by way of transaction, too, picking Voranigo up in its 2021 purchase of Agios Pharmaceuticals for $2 billion. Over on the R&D side of things, Servier will also be able to tap into Day One’s early- to late-stage pipeline, which includes additional programs for tovorafenib in pediatric low-grade gliomas, plus assets running through development in indications like adenoid cystic carcinoma and adult and pediatric solid tumors. Servier says it plans to fund the deal through a mix of existing cash and investments. The company’s share price offer reflects a premium of roughly 68% over Day One’s closing price March 5, according to the companies’ press announcement. “In less than a decade, we have built a durable oncology platform in the United States,” David Lee, CEO of Servier’s U.S. arm, told Fierce in an emailed statement Friday. “That didn’t happen through short-term thinking—it came from sustained investment in science, infrastructure and people.”He reiterated Servier’s ambition to “lead in rare cancers,” noting that for these patients, “progress often depends on a small number of people and organizations choosing to commit when others will not.” Lee continued, “When the science is promising and the need is urgent, we believe it is our responsibility to build the capabilities that can turn discovery into real outcomes for patients.”Servier has long leaned on its patient-centric ethos—credited to its unique governance model under the nonprofit Fondation Internationale de Recherche Servier—as one of the company’s key strengths and distinguishing features. Lee remarked similarly on the company’s governance model allowing Servier “to do things that other companies can’t” and “invest in diseases that other people would not be able to make a business case for” during an interview with Fierce Pharma at the J.P. Morgan Healthcare Conference in 2025. At the time, Lee noted that the landscape for brain cancer treatment remained “pretty open,” adding that, in terms of potential external opportunities for Servier, “anything mutation-driven is still good for us … but we’re open to any [glioblastomas], gliomas or astrocytomas.”Taking a look at the population Ojemda addresses, the FDA has specifically cleared the RAF inhibitor in relapsed or refractory pLGG patients with a BRAF fusion or rearrangement, or BRAF V600 mutation. PLGG is the most common type of childhood brain tumor, with BRAF alterations making up about 1,100 of 1,500 new diagnoses each year. Outside the U.S., Ojemda also won a positive recommendation for approval in the same indication in Europe late last month, a region where Ipsen holds licensing rights to the Day One drug. Servier is making its latest oncology play as the drugmaker seeks to achieve 10 billion euros ($11.5 billion) in annual sales by 2030. After a successful showing in its 2024-25 financial year, which ended in September with 16.2% growth to 6.9 billion euros ($8.2 billion), the group’s president, Olivier Laureau, said in January that Servier was “one important step closer” to meeting that target. Servier didn’t mince words about Voranigo’s contribution to its earnings haul last year, noting that its overall oncology business grew 55% in the 2024-25 fiscal period, with the unit’s contribution toward Servier’s overall revenue rising to 32% from 24% in the previous period. Servier has been busy on the oncology dealmaking front, last year licensing a phase 1 asset from Black Diamond Therapeutics for RAF/RAS-mutant solid tumors, acquiring a phase 1/2 leukemia candidate from BioNova Pharmaceuticals and obtaining ex-U.S. rights to Ideaya Biosciences’ potential first-in-class PKC inhibitor darovasertib under development in uveal melanoma—not to mention an oncology drug discovery pact with artificial intelligence biotech Insilico Medicine made in January. As of late, the company has also been working to bolster its offerings in neurology.

上市批准并购临床1期

2026-02-17

·PRNewswire

IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

130 required PFS events confirmed by BICR in the Phase 2/3 OptimUM-02 trial of darovasertib and crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM); topline results expected by approximately the last week of March Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials in uveal melanoma, including the metastatic, neoadjuvant and adjuvant settings, by H1 '26 Initiation of IDE849 (DLL3 TOP1 ADC) monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) targeted by the end of 2026 Preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial of IDE849 expected by the end of 2026 ~$1.05 billion of cash, cash equivalents, and marketable securities as of December 31, 2025; expected to fund operations into 2030 SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025. "We had a strong quarter of clinical execution, clinical pipeline expansion and commercial readiness activities. The key highlights include completing full enrollment of 437 patients in OptimUM-02, our Phase 2/3 registrational trial in first line HLA*A2-negative mUM, submission of IND filings for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, and IDE574, a KAT6/7 dual inhibitor, and continued build out of our U.S. commercial organization in anticipation of our upcoming topline PFS results," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Recent Developments and Upcoming Milestones Darovasertib in Uveal Melanoma (UM) Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM are expected by approximately the last week of March, pending completion of ongoing data collection, cleaning and analysis. 130 PFS events required to trigger the topline readout have been confirmed by blinded independent central review (BICR); Randomized PFS analysis will be based on the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises a total of approximately 313 patients randomized 2:1 to the treatment arm versus control; Topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States. Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26: OptimUM-02 (mUM): full enrollment of 437 patients is complete; overall survival (OS) data from these patients, when available, are expected to support a filing for full approval in 1L HLA*A2-negative mUM; OptimUM-10 (neoadjuvant): targeting to complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27; OptimUM-11 (adjuvant): trial initiation in collaboration with Servier planned in Q2 '26. Enrollment of approximately 100 HLA*A2-positive mUM patients in single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib is expected to be complete by Q2 '26. Data may support a potential future submission to the U.S. Food and Drug Administration (FDA) to expand the labeled use of darovasertib and/or a national comprehensive cancer network (NCCN)/compendia listing to enable use of the combination in these patients. Targeting to submit two manuscripts for publication with data from 1) treatment naïve mUM patients and 2) HLA*A2-positive mUM patients enrolled in the OptimUM-01 trial in H1 '26 and H2 '26, respectively. Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations IDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026. IDE034 (B7H3/PTK7 bispecific TOP1 ADC): received investigational new drug (IND) clearance from the U.S. FDA in Q4 '25; expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26; Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies. IDE161 (PARG): initiation of clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26. MTAP Pathway IDE397 (MAT2A): planning to provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026. IDE892 (PRMT5): targeting initiation of Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted solid tumors in Q2 '26. Nomination of a development candidate for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, expected in H2 '26 followed by IND submission to the U.S. FDA in H1 '27. Next Generation Therapies IDE574 (KAT6/7): obtained IND clearance from the U.S. FDA in January 2026; targeting to initiate a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers Q1 '26. Corporate Darovasertib commercial readiness activities are advancing in the United States and globally with our partner, Servier. In December 2025, GlaxoSmithKline (GSK) notified IDEAYA of its intention to terminate the Collaboration, Option and License Agreement, dated June 15, 2020. Pursuant to the terms of the Agreement, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to IDEAYA in accordance with the applicable provisions of the Agreement. Fourth Quarter and Full Year 2025 Financial Results As of December 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion, compared to $1.08 billion as of December 31, 2024. The decrease was primarily driven by net cash used in operations, offset by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib during the year ended December 31, 2025. Collaboration revenue for the three months ended December 31, 2025, totaled $10.9 million compared to $7.0 million for the three months ended December 31, 2024. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2025 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of December 31, 2025, the remaining balance for the research and development services performance obligations is $161.8 million related to the clinical trial 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 December 31, 2025 totaled $86.6 million compared to $140.2 million for the three months ended December 31, 2024. The decrease was primarily driven by a $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma during the three months ended December 31, 2024, offset by higher clinical trial and CMC manufacturing expenses to support our programs and personnel-related expenses during the three months ended December 31, 2025. General and administrative (G&A) expenses for the three months ended December 31, 2025 totaled $18.8 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related expenses, higher consulting and legal patent fees to support company growth and darovasertib commercial preparation activities. The net loss for the three months ended December 31, 2025, was $83.3 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended December 31, 2025, was $11.8 million compared to $9.5 million for the three months ended December 31, 2024. The net loss for the year ended December 31, 2025, was $113.7 million compared to the net loss of $274.5 million for the year ended December 31, 2024. Total stock compensation expense for the year ended December 31, 2025, was $46.1 million compared to $34.7 million for the year ended December 31, 2024. 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, including, but not limited to, statements regarding the expected timing and results of clinical trials, including patient enrollment, and data readouts; the potential for accelerated approval or full regulatory approval of darovasertib, alone or in combination with crizotinib; the anticipated design, initiation, enrollment, timing and outcomes of IDEAYA's ongoing and planned Phase 1, Phase 2, and Phase 3 clinical trials across its pipeline programs, including IDE849, IDE034, IDE161, IDE397, IDE892 and IDE574; the therapeutic potential, safety, tolerability, efficacy, and combination potential of IDEAYA's product candidates; the expected prevalence of target patient populations; commercial readiness activities and future commercialization efforts; anticipated collaboration activities and transfers of clinical programs; and IDEAYA's expectations regarding its cash runway and ability to fund operations into 2030. 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 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 [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo

临床1期引进/卖出财报临床3期加速审批

2026-01-29

·今日头条

施维雅罕见病战略显效：肿瘤业务收入猛增54.6% 美国市场贡献近22%

> 全球独立制药集团施维雅2024-2025财年交出了一份远超预期的成绩单：合并收入达69亿欧元，同比增长16.2%，超额完成年度目标。这份亮眼业绩的核心驱动力，是其聚焦罕见病治疗的战略转型，尤其是在肿瘤领域的突破性进展，以及由此带来的美国市场爆发式增长。 https://p3-doubao-search-sign.byteimg.com/labis/image/28749d2350626979a56cc29d2328ff63~tplv-be4g95zd3a-image.jpeg?lk3s=feb11e32&x-expires=1774879047&x-signature=tdrPkiJEf2ERJihDrtHwvF3TL4A%3D 1. 业绩解码：肿瘤业务成绝对引擎，美国市场贡献突出财报数据显示，**肿瘤业务**已成为施维雅增长的核心引擎。该板块收入同比激增**54.6%**，达到**22.1亿欧元**，占集团总收入的比重从上一财年的24.2%跃升至**32.2%**。 https://p3-doubao-search-sign.byteimg.com/labis/image/faf6ec136c04a2a75a24d46899b06486~tplv-be4g95zd3a-image.jpeg?lk3s=feb11e32&x-expires=1774879047&x-signature=fXZGTFzL%2BUNqK%2B%2Bs4PNgnfHhpJA%3D 增长的关键动力源于其罕见脑部肿瘤靶向药**Voranigo®**。该药物在美国上市后销售迅速放量，并推动施维雅美国子公司收入同比猛增**70.3%**，达到14.96亿欧元，贡献了集团近**22%** 的总收入。目前，Voranigo®已在全球近**45个国家和地区**获批，并通过早期用药项目惠及全球超过**5500名患者**。与此同时，集团传统优势领域——心血管代谢与静脉疾病业务保持稳健，收入**29.68亿欧元**，同比增长1.8%。 2. 战略纵深：从肿瘤到神经科学，罕见病研发双线并进施维雅正将其在肿瘤罕见病领域的成功模式，复制到更具挑战的神经科学领域。集团明确将**神经科学**作为下一个战略重点，旨在成为该领域的领先者。其神经科学研发管线目前聚焦三类与遗传或免疫炎症机制相关的罕见疾病： - **难治性癫痫** - **罕见运动障碍** - **神经肌肉疾病** 在技术路线上，研发专注于**靶向mRNA的小分子药物**，尤其是**反义寡核苷酸（ASOs）**，以及药理活性分子和单克隆抗体。目前，管线共包含**11个项目**，其中8个处于研究阶段，3个处于开发阶段。具体进展方面，集团已启动一款用于治疗儿童**发育性和癫痫性脑病（DEE）**药物的I期临床研究。此外，施维雅还与**伦敦大学学院**合作，在名为“**大脑类组装体**”的创新细胞模型中测试其ASOs疗法，该模型能模拟人脑发育的关键特征。 3. 外部赋能：合作与AI加速管线构建为加速罕见病药物研发，施维雅采取了积极的外部合作策略。本财年，集团签署了三项关键肿瘤合作协议： - 与Black Diamond Therapeutics合作开发针对实体瘤（含非小细胞肺癌）的靶向疗法。 - 收购中国BioNova Pharmaceuticals的一款急性白血病精准疗法。 - 与IDEAYA Biosciences合作推进治疗罕见眼癌（葡萄膜黑色素瘤）的潜在疗法Darovasertib。人工智能（AI）也被全面融入研发流程。施维雅与AI制药公司英矽智能达成了一项总额高达**8.88亿美元**的多年期研发合作，旨在利用AI平台加速抗肿瘤创新疗法的发现。集团表示，AI技术有助于解析复杂生物学机制，在肿瘤与神经科学等罕见病领域，显著加速为特定患者寻找精准治疗方案的过程。 4. 迈向2030：验证战略与未来挑战施维雅财务执行副总裁Pascal Lemaire指出：“肿瘤业务在美国的成功**验证了我们全球增长战略的有效性**。” 稳健的业绩增长为集团设定了更具雄心的2030年目标，特别是实现**百亿欧元营收**，提供了信心支撑。施维雅的转型路径已清晰可见：以罕见病为战略核心，凭借在肿瘤领域已验证的研发与商业化能力，向神经科学等新领域拓展。通过“自主研发+全球合作”以及积极拥抱AI等前沿技术，这家独立制药集团正在构建一个更具竞争力和可持续性的创新药物管线。然而，如何将肿瘤领域的成功经验有效移植到研发周期更长、失败率可能更高的神经科学领域，将是其实现长期目标的关键考验。

100 项与 Darovasertib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16059

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
葡萄膜黑色素瘤	临床3期	法国	Les Laboratoires Servier SAS	2025-10-01
结直肠癌	临床2期	美国	IDEAYA Biosciences, Inc.	2019-06-28
结直肠癌	临床2期	澳大利亚	IDEAYA Biosciences, Inc.	2019-06-28
结直肠癌	临床2期	加拿大	IDEAYA Biosciences, Inc.	2019-06-28
皮肤黑色素瘤	临床2期	美国	IDEAYA Biosciences, Inc.	2019-06-28
皮肤黑色素瘤	临床2期	澳大利亚	IDEAYA Biosciences, Inc.	2019-06-28
皮肤黑色素瘤	临床2期	加拿大	IDEAYA Biosciences, Inc.	2019-06-28

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05987332 (IDE196-002, ESMO2024)	临床2/3期	葡萄膜黑色素瘤一线 GNAQ/11 \| HLA-A*02:01	-	IDE196 + crizotinib	憲齋襯網選齋觸繭淵築(網襯範衊夢襯襯夢衊窪) = 窪憲網壓壓衊窪膚齋窪膚範鏇醖觸簾遞網壓壓 (鹹製築鬱鑰繭範築簾顧 )	积极	2024-09-14
NCT05187884 (NADOM, ASCO2024) 人工标引	临床2期	眼部黑色素瘤新辅助 \| 辅助	15	Darovasertib	鹹襯鹹衊衊壓製網蓋壓(遞網繭襯糧艱繭製鹽鏇) = 憲壓鏇遞觸積蓋艱廠壓蓋憲獵網繭範齋遞糧壓 (醖蓋選夢餘廠積鏇願蓋 ) 更多	积极	2024-05-24
NCT03947385 (ESMO2023) 人工标引	临床1/2期	葡萄膜黑色素瘤一线	68	darovaserti + crizotinib (treated at the expansion dose)	網選襯築簾範顧構膚淵(淵膚鑰糧簾積壓願繭壓) = 構餘糧範獵衊鬱醖繭顧艱壓製網鬱窪鏇築憲繭 (選廠衊醖夢淵獵鬱鬱蓋 ) 更多	积极	2023-10-23
NCT03947385 (ESMO2023) 人工标引	临床1/2期	葡萄膜黑色素瘤一线	68	darovasertib + crizotinib (pts with hepatic only disease)	網選襯築簾範顧構膚淵(淵膚鑰糧簾積壓願繭壓) = 選淵艱製繭廠膚範鏇窪艱壓製網鬱窪鏇築憲繭 (選廠衊醖夢淵獵鬱鬱蓋 ) 更多	积极	2023-10-23
NCT03947385 (Corporate Publications) 人工标引	临床1/2期	葡萄膜黑色素瘤	37	Crizotinib+Darovasertib (Any-Line MUM)	鹹鑰鏇廠廠遞簾構獵壓(構願襯獵鬱壓鹽膚構築) = 遞選選簾簾鹹淵鑰鏇遞艱製蓋壓鬱糧憲夢餘積 (觸壓廠鑰築鹹夢糧鏇鏇 ) 更多	积极	2022-09-11
NCT03947385 (Corporate Publications) 人工标引	临床1/2期	葡萄膜黑色素瘤	37	Crizotinib+Darovasertib (First-Line MUM)	鹹鑰鏇廠廠遞簾構獵壓(構願襯獵鬱壓鹽膚構築) = 願艱範鬱衊顧選衊醖壓艱製蓋壓鬱糧憲夢餘積 (觸壓廠鑰築鹹夢糧鏇鏇 )	积极	2022-09-11