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IDEAYA Announces IDMC Recommendation of Move-Forward Dose in Part 2a of Registration-Enabling Trial of Darovasertib and Crizotinib Combination in 1L HLA-A2-Negative Metastatic Uveal Melanoma

IDEAYA Announces IDMC Recommendation of Move-Forward Dose in Part 2a of Registration-Enabling Trial of Darovasertib and Crizotinib Combination in 1L HLA-A2-Negative Metastatic Uveal Melanoma

IDEAYA宣布IDMC推荐在1L HLA-A2阴性转移性眼黑色素瘤注册启用试验第2a部分中推进使用达罗伐替和克唑替尼的剂量
PR Newswire ·  12/17 19:00
  • Independent Data Monitoring Committee (IDMC) recommends move-forward dose in Part 2a of potential registration-enabling trial in 1L HLA-A2-Negative MUM, based on clinical efficacy and safety observed
  • Over 185 patients enrolled in potential registration-enabling trial in 1L HLA-A2-Negative MUM, and the darovasertib and crizotinib combination has received U.S. Food and Drug Administration (FDA) Fast Track designation in MUM
  • 独立数据监测委员会(IDMC)根据观察到的临床疗效和安全性,建议在潜在注册的1L HLA-A2阴性转移性眼黑色素瘤(MUm)试验的第2a部分推进剂量。
  • 在潜在注册的1L HLA-A2阴性MUm试验中,招募了超过185名患者,达罗伐替尼和克唑替尼的联合用药获得了美国食品和药物管理局(FDA)的快速通道认证。

SAN FRANCISCO, Dec. 17, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the Independent Data Monitoring Committee (IDMC) recommendation of a move-forward dose and the completion of the Part 2a dose optimization consistent with the U.S. Food and Drug Administration's (FDA) Project Optimus guidelines for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line (1L) setting in patients with HLA-A2-negative (HLA-A2(-)) metastatic uveal melanoma (MUM).

旧金山,2024年12月17日 /PRNewswire/ -- IDEAYA生物科学公司(纳斯达克:IDYA),一家致力于靶向治疗药物的发现和开发的精准医学肿瘤学公司,今天宣布独立数据监测委员会(IDMC)推荐推进剂量,并完成了与美国食品和药物管理局(FDA)Project Optimus 指南一致的第2a部分剂量优化,以便在第一线(1L)设置中评估达罗伐替尼和克唑替尼联合用药的潜在注册Phase 2/3试验,参与者为HLA-A2阴性(HLA-A2(-))转移性眼黑色素瘤(MUM)患者。

"We are pleased with the recommendation of the IDMC and the selection of the move-forward dose for our potential registration-enabling trial evaluating the darovasertib and crizotinib combination in first-line HLA-A2(-) MUM patients. This allows us to complete the Part 2a portion of the study and seamlessly continue to enroll in Part 2b towards a potential accelerated approval based on the primary endpoint of median progression free survival," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

“我们对IDMC的推荐和为我们评估达罗伐替尼和克唑替尼联合用药在第一线HLA-A2(-) MUm患者中的潜在注册试验选择推进剂量感到满意。这使我们能够完成研究的第2a部分,并无缝继续在第20亿部分招募,旨在根据中位无进展生存期的主要终点实现潜在的加速批准,” IDEAYA生物科学首席医疗官Darrin m. Beaupre万. D.博士说道。

"The combination of darovasertib and crizotinib as first-line treatment has shown compelling preliminary clinical results in patients with HLA-A2(-) MUM. The IDMC recommendation of the move-forward dose supports the advancement of this potentially registration-enabling Phase 2/3 trial and is an important step in bringing a new treatment option to patients with MUM. Additionally, the continued rapid enrollment further validates the strong interest from physicians and patients, and highlights the significant unmet need in these patients, who historically have faced a poor prognosis," added Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute, and clinical investigator on the potential registration-enabling clinical trial.

“达罗伐替尼和克唑替尼作为第一线治疗的联合用药在HLA-A2(-) MUm患者中显示出令人信服的初步临床结果。IDMC对于推进剂量的推荐支持了这一潜在注册的Phase 2/3试验的推进,并且是在为MUm患者提供新治疗选择的重要一步。此外,持续的快速招募进一步验证了医生和患者的强烈兴趣,并突显了这些患者所面临的重大未满足需求,他们在历史上通常有较差的预后,”梅雷迪思·麦基万万.D.,MPH,Sarah Cannon研究所黑色素瘤与皮肤癌研究主任及潜在注册临床试验的临床研究者补充道。

The darovasertib and crizotinib combination in MUM has FDA Fast Track designation and is currently being evaluated in two clinical trials: a potentially registration-enabling Phase 2/3 trial of darovasertib and crizotinib combination in first-line HLA-A2(-) MUM (NCT05987332) and a Phase 2 trial (NCT03947385). Additionally, darovasertib as neoadjuvant monotherapy is currently being evaluated in a Phase 2 trial in primary uveal melanoma (NCT05907954). IDEAYA is also finalizing a clinical trial protocol and is targeting to initiate a potential Phase 3 registration-enabling study for neoadjuvant uveal melanoma patients in the first half of 2025.

darovasertib和crizotinib的组合在MUm中获得了FDA快速通道认证,目前正在进行两个临床试验:一个是darovasertib和crizotinib组合在一线HLA-A2(-) MUm中的潜在注册的2/3期试验(NCT05987332),另一个是2期试验(NCT03947385)。此外,darovasertib作为新辅助单药治疗目前正在对原发性睫状膜黑色素瘤进行2期试验(NCT05907954)。IDEAYA还在完善临床试验方案,预计将在2025年上半年启动针对新辅助睫状膜黑色素瘤患者的潜在3期注册研究。

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

关于IDEAYA Biosciences
IDEAYA是一家精准医学肿瘤学公司,致力于针对使用分子诊断选择的患者群体发现和开发靶向治疗。IDEAYA的方法结合了识别和验证转化生物标志物的能力与药物发现,以选择最有可能从其靶向疗法中受益的患者群体。IDEAYA正在将其研究和药物发现能力应用于合成致死性——这代表了新兴的精准医学靶标类别。

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the progress of the clinical development of the darovasertib and crizotinib combination in first-line HLA-A2 (-) MUM trial, (ii) the potential clinical efficacy, safety and therapeutic benefit of the darovasertib/crizotinib combination (iii) the registrational trial enrollment schedule of darovasertib/crizotinib combination in MUM (iv) the US FDA Fast Track designation and potential accelerated approval of the darovasertib/crizotinib combination in MUM; (v) the unmet need of patients with HLA-A2(-)MUM; (vi) the development progress of Phase 2 trials of darovasertib as neoadjuvant monotherapy in primary uveal melanoma; (vii) the timing of initiating a potential Phase 3 registration enabling study for neoadjuvant uveal melanoma patients in the first half of 2025. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly 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 IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, 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. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the 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, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

前瞻性声明
本新闻稿包含前瞻性声明,包括但不限于与以下事项相关的声明:(i)darovasertib和crizotinib组合在一线HLA-A2(-) MUm试验的临床开发进展,(ii)darovasertib/crizotinib组合的潜在临床有效性、安全性和治疗益处,(iii)darovasertib/crizotinib组合在MUm中的注册试验入组时间表,(iv)美国FDA快速通道认证和darovasertib/crizotinib组合在MUM中的潜在加速审批;(v)HLA-A2(-) MUM患者的未满足需求;(vi)作为新辅助单药的darovasertib在原发性睫状膜黑色素瘤中的2期试验发展进度;(vii)预计在2025年上半年启动针对新辅助睫状膜黑色素瘤患者的潜在3期注册研究的时间。这些前瞻性声明涉及 substantial 的风险和不确定性,可能导致IDEAYA的临床前和临床开发项目、未来结果、业绩或成就与前瞻性声明中所表达或暗示的显著不同。这些风险和不确定性包括但不限于药物开发过程中的不确定性,包括IDEAYA项目处于开发的早期阶段、设计和进行临床前和临床试验的过程、监管批准程序、监管申请的时间、制造药物产品相关的挑战、IDEAYA成功建立、保护和捍卫其知识产权的能力,以及可能影响现有现金不足以支持运营的其他问题。IDEAYA没有更新或修订任何前瞻性声明的义务。有关可能导致实际结果与这些前瞻性声明所表达的内容不同的风险和不确定性的进一步说明,以及与IDEAYA业务一般相关的风险,请参阅IDEAYA于2024年2月20日提交的10-K表格年度报告及向美国证券交易委员会提交的任何当前和定期报告。

Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
[email protected]

投资者和媒体联系方式
IDEAYA生物科学公司
安德烈斯·鲁伊斯·布里塞诺
高级副总裁,财务及投资者关系负责人
[email protected]

SOURCE IDEAYA Biosciences, Inc.

来源:IDEAYA生物科学公司。

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