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 Biosciences announced that the Independent Data Monitoring Committee (IDMC) has recommended a move-forward dose in Part 2a of their potential registration-enabling Phase 2/3 trial for the darovasertib and crizotinib combination in first-line HLA-A2-negative metastatic uveal melanoma (MUM) patients. The trial has enrolled over 185 patients and received FDA Fast Track designation.
The recommendation allows completion of Part 2a and seamless continuation to Part 2b, targeting potential accelerated approval based on median progression free survival. The combination therapy is being evaluated in two clinical trials, including the Phase 2/3 registration-enabling trial and a separate Phase 2 trial. Additionally, darovasertib is being studied as neoadjuvant monotherapy in primary uveal melanoma, with plans to initiate a Phase 3 registration-enabling study in first half of 2025.
IDEAYA Biosciences ha annunciato che il Comitato Indipendente di Monitoraggio dei Dati (IDMC) ha raccomandato di proseguire con una dose nel Parte 2a del loro potenziale studio clinico di registrazione di fase 2/3 per la combinazione di darovasertib e crizotinib in pazienti con melanoma uveal metastatico (MUM) negativi per HLA-A2 in prima linea. Lo studio ha arruolato oltre 185 pazienti e ha ricevuto la designazione di Fast Track dalla FDA.
La raccomandazione consente di completare la Parte 2a e di passare senza soluzione di continuità alla Parte 2b, mirando a una potenziale approvazione accelerata basata sulla sopravvivenza libera da progressione mediana. La terapia combinata è in fase di valutazione in due studi clinici, incluso lo studio di registrazione di fase 2/3 e un separato studio di fase 2. Inoltre, il darovasertib è studiato come monoterapia neoadiuvante nel melanoma uveal primario, con piani per avviare uno studio di registrazione di fase 3 nella prima metà del 2025.
IDEAYA Biosciences anunció que el Comité Independiente de Monitoreo de Datos (IDMC) recomendó avanzar con una dosis en la Parte 2a de su potencial ensayo de fase 2/3 que habilita el registro para la combinación de darovasertib y crizotinib en pacientes con melanoma uveal metastásico negativo para HLA-A2 (MUM) en primera línea. El ensayo ha inscrito a más de 185 pacientes y recibió la designación de Fast Track por parte de la FDA.
La recomendación permite completar la Parte 2a y continuar sin problemas hacia la Parte 2b, apuntando a una posible aprobación acelerada basada en la supervivencia libre de progresión mediana. La terapia combinada se está evaluando en dos ensayos clínicos, incluido el ensayo de habilitación de registro de fase 2/3 y un ensayo separado de fase 2. Además, se está estudiando el darovasertib como monoterapia neoadyuvante en melanoma uveal primario, con planes de iniciar un estudio de habilitación de registro de fase 3 en la primera mitad de 2025.
IDEAYA Biosciences는 독립 데이터 모니터링 위원회(IDMC)가 1차 HLA-A2 음성 전이성 유리막 흑색종(MUM) 환자를 대상으로 한 다로바세르티브와 크리조티닙 조합에 대한 잠재적 등록 허가가 가능한 2/3상 시험의 2a 부분에서 진행 용량을 권고했다고 발표했습니다. 이 시험은 185명 이상의 환자를 모집하였으며, FDA의 패스트 트랙 지정도 받았습니다.
이 권고는 2a 부분을 완료하고 2b 부분으로 원활하게 계속 진행할 수 있도록 하여, 중간 무진행 생존 기간을 기반으로 잠재적인 가속 승인을 목표로 하고 있습니다. 이 조합 요법은 2/3상 등록 허가 시험과 별도의 2상 시험 등 두 개의 임상 시험에서 평가되고 있습니다. 또한, 다로바세르티브는 1차 유리막 흑색종에서 네오어주번트 단독 요법으로 연구되고 있으며, 2025년 상반기 내에 3상 등록 허가 연구를 시작할 계획입니다.
IDEAYA Biosciences a annoncé que le Comité Indépendant de Surveillance des Données (IDMC) a recommandé de procéder à un dosage dans la Partie 2a de leur essai clinique en phase 2/3, habilitant à l'enregistrement, pour la combinaison de darovasertib et de crizotinib chez des patients atteints de mélanome uveal métastatique (MUM) négatif pour HLA-A2 en première ligne. L'essai a recruté plus de 185 patients et a reçu la désignation Fast Track de la FDA.
La recommandation permet de compléter la Partie 2a et de poursuivre de manière fluide vers la Partie 2b, avec pour objectif une approbation accélérée basée sur la survie médiane sans progression. La thérapie combinée est évaluée dans deux essais cliniques, y compris l'essai de phase 2/3 habilitant à l'enregistrement et un essai séparé de phase 2. De plus, le darovasertib est étudié comme monothérapie néoadjuvante dans le mélanome uveal primaire, avec des plans pour initier une étude de phase 3 habilitant à l'enregistrement dans la première moitié de 2025.
IDEAYA Biosciences gab bekannt, dass der Unabhängige Datenüberwachungsrat (IDMC) empfohlen hat, mit einer Dosis in Teil 2a ihrer potenziellen registrierungsermöglichenden Phase 2/3-Studie für die Kombination aus Darovasertib und Crizotinib bei HLA-A2-negativen metastatischen uvealen Melanom-Patienten (MUM) fortzufahren. Die Studie hat über 185 Patienten eingeschlossen und erhielt die Fast Track-Bezeichnung von der FDA.
Die Empfehlung ermöglicht den Abschluss von Teil 2a und einen nahtlosen Übergang zu Teil 2b, mit dem Ziel einer potenziellen beschleunigten Genehmigung basierend auf dem medianen progressionsfreien Überleben. Die Kombinationstherapie wird in zwei klinischen Studien evaluiert, einschließlich der Phase 2/3-Registrierungsstudie und einer separaten Phase 2-Studie. Darüber hinaus wird Darovasertib als neoadjuvante Monotherapie bei primärem uvealem Melanom untersucht, mit dem Ziel, im ersten Halbjahr 2025 eine Phase 3-Registrierungsstudie zu beginnen.
- FDA Fast Track designation received for darovasertib and crizotinib combination
- Strong enrollment with over 185 patients in registration-enabling trial
- IDMC's positive recommendation for move-forward dose enables progression to Part 2b
- Potential for accelerated approval pathway
- None.
Insights
- 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
"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.
"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.
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.
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.
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
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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FAQ
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