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
- 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
- 獨立數據監測委員會(IDMC)根據觀察到的臨床療效和安全性,建議在潛在註冊的1L HLA-A2陰性轉移性眼黑色素瘤(MUm)試驗的第2a部分推進劑量。
- 在潛在註冊的1L HLA-A2陰性MUm試驗中,招募了超過185名患者,達羅伐替尼和克唑替尼的聯合用藥獲得了美國食品和藥物管理局(FDA)的快速通道認證。
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).
舊金山,2024年12月17日 /PRNewswire/ -- IDEAYA生物科學公司(納斯達克:IDYA),一家致力於靶向治療藥物的發現和開發的精準醫學腫瘤學公司,今天宣佈獨立數據監測委員會(IDMC)推薦推進劑量,並完成了與美國食品和藥物管理局(FDA)Project Optimus 指南一致的第2a部分劑量優化,以便在第一線(1L)設置中評估達羅伐替尼和克唑替尼聯合用藥的潛在註冊Phase 2/3試驗,參與者爲HLA-A2陰性(HLA-A2(-))轉移性眼黑色素瘤(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.
「我們對IDMC的推薦和爲我們評估達羅伐替尼和克唑替尼聯合用藥在第一線HLA-A2(-) MUm患者中的潛在註冊試驗選擇推進劑量感到滿意。這使我們能夠完成研究的第2a部分,並無縫繼續在第20億部分招募,旨在根據中位無進展生存期的主要終點實現潛在的加速批准,」 IDEAYA生物科學首席醫療官Darrin m. Beaupre萬. D.博士說道。
"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.
「達羅伐替尼和克唑替尼作爲第一線治療的聯合用藥在HLA-A2(-) MUm患者中顯示出令人信服的初步臨床結果。IDMC對於推進劑量的推薦支持了這一潛在註冊的Phase 2/3試驗的推進,並且是在爲MUm患者提供新治療選擇的重要一步。此外,持續的快速招募進一步驗證了醫生和患者的強烈興趣,並突顯了這些患者所面臨的重大未滿足需求,他們在歷史上通常有較差的預後,」梅雷迪思·麥基萬萬.D.,MPH,Sarah Cannon研究所黑色素瘤與皮膚癌研究主任及潛在註冊臨床試驗的臨床研究者補充道。
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的組合在MUm中獲得了FDA快速通道認證,目前正在進行兩個臨床試驗:一個是darovasertib和crizotinib組合在一線HLA-A2(-) MUm中的潛在註冊的2/3期試驗(NCT05987332),另一個是2期試驗(NCT03947385)。此外,darovasertib作爲新輔助單藥治療目前正在對原發性睫狀膜黑色素瘤進行2期試驗(NCT05907954)。IDEAYA還在完善臨床試驗方案,預計將在2025年上半年啓動針對新輔助睫狀膜黑色素瘤患者的潛在3期註冊研究。
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.
關於IDEAYA Biosciences
IDEAYA是一家精準醫學腫瘤學公司,致力於針對使用分子診斷選擇的患者群體發現和開發靶向治療。IDEAYA的方法結合了識別和驗證轉化生物標誌物的能力與藥物發現,以選擇最有可能從其靶向療法中受益的患者群體。IDEAYA正在將其研究和藥物發現能力應用於合成致死性——這代表了新興的精準醫學靶標類別。
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.
前瞻性聲明
本新聞稿包含前瞻性聲明,包括但不限於與以下事項相關的聲明:(i)darovasertib和crizotinib組合在一線HLA-A2(-) MUm試驗的臨床開發進展,(ii)darovasertib/crizotinib組合的潛在臨床有效性、安全性和治療益處,(iii)darovasertib/crizotinib組合在MUm中的註冊試驗入組時間表,(iv)美國FDA快速通道認證和darovasertib/crizotinib組合在MUM中的潛在加速審批;(v)HLA-A2(-) MUM患者的未滿足需求;(vi)作爲新輔助單藥的darovasertib在原發性睫狀膜黑色素瘤中的2期試驗發展進度;(vii)預計在2025年上半年啓動針對新輔助睫狀膜黑色素瘤患者的潛在3期註冊研究的時間。這些前瞻性聲明涉及 substantial 的風險和不確定性,可能導致IDEAYA的臨床前和臨床開發項目、未來結果、業績或成就與前瞻性聲明中所表達或暗示的顯著不同。這些風險和不確定性包括但不限於藥物開發過程中的不確定性,包括IDEAYA項目處於開發的早期階段、設計和進行臨床前和臨床試驗的過程、監管批准程序、監管申請的時間、製造藥物產品相關的挑戰、IDEAYA成功建立、保護和捍衛其知識產權的能力,以及可能影響現有現金不足以支持運營的其他問題。IDEAYA沒有更新或修訂任何前瞻性聲明的義務。有關可能導致實際結果與這些前瞻性聲明所表達的內容不同的風險和不確定性的進一步說明,以及與IDEAYA業務一般相關的風險,請參閱IDEAYA於2024年2月20日提交的10-K表格年度報告及向美國證券交易委員會提交的任何當前和定期報告。
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
[email protected]
投資者和媒體聯繫方式
IDEAYA生物科學公司
安德烈斯·魯伊斯·布里塞諾
高級副總裁,財務及投資者關係負責人
[email protected]
SOURCE IDEAYA Biosciences, Inc.
來源:IDEAYA生物科學公司。
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