SOUTH SAN FRANCISCO, Calif., June 3, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced updated clinical results from the ongoing investigator-sponsored Phase 2 trial of darovasertib, a first-in-class oral, small molecular inhibitor of protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (UM) and clinical update for Phase 2 company-sponsored neoadjuvant UM study.

加利福尼亚州南旧金山，2024年6月3日/PRNewswire/-IDEAYA Biosciences，Inc.（纳斯达克：IDIA），一家致力于发现和开发靶向治疗药物的精准医学肿瘤学公司，今天宣布了正在进行的由研究者赞助的darovasertib（一种一流的口服小分子蛋白激酶C（PKC）抑制剂）的2期临床试验的最新临床结果，作为葡萄膜黑色素瘤（UM）的新辅助/辅助治疗，以及公司赞助的2期新辅助UM研究的临床更新。

The clinical data from the ongoing investigator-sponsored Phase 2 trial were included in an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting..

正在进行的研究者赞助的2期临床试验的临床数据被纳入美国临床肿瘤学会（ASCO）2024年年会的口头报告中。。

'The clinical data presented at ASCO provides further validation for the potential of darovasertib in the neoadjuvant UM setting to preserve the eye and to shrink ocular tumors for UM patients,' said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. 'We believe neoadjuvant and adjuvant UM represent high unmet medical needs and indication expansion opportunities that are potential first-line treatment opportunities across the patient journey and irrespective of HLA-A2 status that will significantly expand the addressable patient population for darovasertib beyond the metastatic setting.'.

IDEAYA Biosciences总裁兼首席执行官Yujiro S.Hata说：“ASCO提供的临床数据进一步验证了darovasertib在新辅助UM环境中保护眼睛和缩小UM患者眼部肿瘤的潜力。”我们认为新辅助和辅助UM代表了高度未满足的医疗需求和适应症扩展机会，这些机会是整个患者旅程中潜在的一线治疗机会，而不管HLA-A2状态如何，这将显着扩大达罗伐他汀的可寻址患者群，使其超出转移环境。

'The clinical data presented at ASCO highlights the potential of darovasertib as a neoadjuvant treatment to provide meaningful tumor shrinkage in patients with ocular tumors and spare patients from enucleation, with a manageable AE profile,' added Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDEAYA Biosciences首席医疗官Darrin Beaupre医学博士补充道：“ASCO提供的临床数据突出了darovasertib作为新辅助治疗的潜力，可为眼部肿瘤患者提供有意义的肿瘤缩小，并使患者免于去核，并具有可控的AE特征。”。

'We are targeting a Type C meeting with the FDA in H2 2024 for guidance on a potential registrational trial in neoadjuvant UM, and we are encouraged by the rapid enrollment, and preliminary clinical efficacy and safety observed from IDEAYA's company-sponsored Phase 2 neoadjuvant UM trial.'.

“我们计划于2024年下半年与FDA举行C型会议，以指导新辅助UM的潜在注册试验，我们对IDEAYA公司赞助的2期新辅助UM试验的快速注册以及初步临床疗效和安全性感到鼓舞。”。

Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in Sydney, and the lead principal investigator of the Phase 2 study, presented clinical results from the Phase 2 Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma (NADOM) at ASCO.

Anthony Joshua，MBBS博士，FRCP，悉尼圣文森特医院金霍恩癌症中心医学肿瘤学系主任，2期研究的首席首席研究员，介绍了ASCO达罗伐他汀治疗眼部黑色素瘤（NADOM）的2期新辅助/辅助试验的临床结果。

Fifteen patients planned for enucleation with localized UM were treated with darovasertib 300mg twice daily. An initial safety cohort of three patients were treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy or external beam radiotherapy (EBRT)) across three Australian centers..

计划用局部UM去核的15名患者每天两次用达罗伐他汀300mg治疗。三名患者的初始安全队列治疗了一个月，其余12名患者在三个澳大利亚中心进行初次干预（去核，斑块近距离放射治疗或外照射放射治疗（EBRT））之前，在扩展队列中接受了长达六个月的新辅助治疗。。

As of the database lock on May 14, 2024, 13 patients had completed neoadjuvant treatment, 11 patients received adjuvant darovasertib after primary treatment of their UM, with five patients completing the planned six months of therapy. As of May 14, 2024, 75% (9 out of 12 enucleation patients) had confirmed Eye Saved (i.e., converted to plaque brachytherapy or EBRT) and approximately 67% (8 out of 12 enucleation patients) observed greater than 30% tumor shrinkage (maximum volume change) after 6 months.

截至2024年5月14日数据库锁定，13名患者完成了新辅助治疗，11名患者在其UM初次治疗后接受了辅助darovasertib，其中5名患者完成了计划的6个月治疗。截至2024年5月14日，75%（12例去核患者中有9例）已确认眼部保存（即转换为斑块近距离放射治疗或EBRT），约67%（12例去核患者中有8例）在6个月后观察到肿瘤缩小超过30%（最大体积变化）。

Median tumor shrinkage (maximum volume change) in 12 enucleation patients was approximately 47% after 6 months..

6个月后，12例去核患者的中位肿瘤缩小（最大体积变化）约为47%。。

The darovasertib monotherapy neoadjuvant treatment had a manageable adverse event (AE) profile with no drug-related serious adverse events observed. Drug-related AEs were predominantly Grade 1 or Grade 2 and 20% of patients reported at least one drug-related Grade 3 adverse event.

达罗伐他汀单药治疗新辅助治疗具有可控的不良事件（AE）特征，未观察到与药物相关的严重不良事件。与药物相关的AE主要是1级或2级，20%的患者报告至少一次与药物相关的3级不良事件。

The Company is targeting a Type C meeting with the FDA to discuss a potential registrational trial for darovasertib in the neoadjuvant UM setting and a clinical efficacy update from its Phase 2 company-sponsored darovasertib neoadjuvant UM trial in H2 2024. As of May 24, 2024 cut-off date, the Phase 2 company-sponsored darovasertib neoadjuvant UM trial has activated over 14 sites globally and enrolled over 40 patients.

该公司计划与FDA举行C型会议，讨论达罗伐他汀在新辅助UM环境中的潜在注册试验，以及2024年下半年公司赞助的达罗伐他汀新辅助UM试验的第二阶段临床疗效更新。截至2024年5月24日截止日期，第二阶段公司赞助的darovasertib新辅助UM试验已在全球激活了14个地点，招募了40多名患者。

As of the cut-off date, 8 patients (6 enucleation and 2 plaque eligible) have been on darovasertib treatment for 4-months or more and observed median tumor shrinkage (maximum height/base/volume change) of approximately 40%/25%/72% and the majority of the 6 enucleation patients had reported Eye Saved (i.e., converted to plaque brachytherapy or EBRT eligible)..

截至截止日期，8名患者（6名摘除术和2名符合斑块条件的患者）接受了darovasertib治疗4个月或更长时间，观察到中位肿瘤缩小（最大身高/基部/体积变化）约为40%/25%/72%，并且6名摘除术患者中的大多数报告了眼睛保存（即转换为斑块近距离放射治疗或符合EBRT条件）。。

In the 8 patients with 4-months or more of darovasertib treatment as of May 24, 2024, darovasertib had a manageable AE profile with no drug-related serious adverse events observed, and drug-related AEs were predominantly Grade 1 or Grade 2 and approximately 13% of patients reported at least one drug-related Grade 3 AE..

截至2024年5月24日，在接受达罗伐他汀治疗4个月或更长时间的8例患者中，达罗伐他汀具有可控的AE特征，未观察到与药物相关的严重不良事件，与药物相关的AE主要为1级或2级，约13%的患者报告至少有一种与药物相关的3级AE。。

The darovasertib program has ongoing enrollment of a potential registrational Phase 2/3 trial in first-line HLA-A2-negative metastatic UM (MUM), and Phase 2 trials in HLA-A2 positive MUM and neoadjuvant and adjuvant UM. Darovasertib received FDA Fast Track designation in MUM and FDA Orphan Drug designation for the treatment of Uveal Melanoma, including MUM.

darovasertib计划正在进行一线HLA-A2阴性转移性UM（MUM）的潜在注册2/3期试验，以及HLA-A2阳性MUM和新辅助和辅助UM的2期试验。darovasertib在MUM中获得了FDA快速通道指定，FDA孤儿药指定用于治疗葡萄膜黑色素瘤，包括MUM。

We project the global annual incidence of primary uveal melanoma is approximately 8,000 to 10,000 patients, with the majority of patients in the U.S. and Europe..

我们预计全球原发性葡萄膜黑色素瘤的年发病率约为8000至10000名患者，其中大多数患者在美国和欧洲。。

A copy of the ASCO oral presentation and clinical data update from the Phase 2 company-sponsored darovasertib neoadjuvant UM trial summarized in the Corporate Presentation will be available on the Investor Relations section of the website at approximately 8:05am EST on Monday, June 3rd, 2024.

美国东部时间2024年6月3日星期一上午8:05左右，网站的投资者关系部分将提供公司赞助的darovasertib新辅助UM试验第二阶段ASCO口头报告和临床数据更新的副本。

About IDEAYA Biosciences

关于IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.

IDEAYA是一家精准医学肿瘤学公司，致力于为使用分子诊断选择的患者群体发现和开发靶向治疗药物。IDEAYA的方法将识别和验证转化生物标志物的能力与药物发现相结合，以选择最有可能从其靶向治疗中受益的患者群体。

IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets..

IDEAYA正在将其研究和药物发现能力应用于合成致死率，这代表了一类新兴的精准医学目标。。