IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2025 for Phase 2 Clinical Trial of Neoadjuvant Darovasertib in Primary Uveal Melanoma
IDEAYA Biosciences (NASDAQ:IDYA) announced that results from their Phase 2 study of neoadjuvant darovasertib in primary uveal melanoma will be presented at ESMO 2025 in Berlin. The study includes data from over 90 patients across plaque brachytherapy and enucleation-eligible cohorts.
The presentation will highlight darovasertib's potential impact on disease management, particularly notable as it has received FDA Breakthrough Therapy Designation for neoadjuvant use in uveal melanoma patients requiring enucleation. The company has also initiated OptimUM-10, a global Phase 3 neoadjuvant registrational trial, in Q3 2025.
IDEAYA Biosciences (NASDAQ:IDYA) ha annunciato che i risultati del loro studio di Fase 2 sul darovasertib neoadiuvante nel melanoma uveale primario saranno presentati al ESMO 2025 a Berlino. Lo studio include dati provenienti da oltre 90 pazienti appartenenti ai gruppi trattati con brachiterapia a placca e candidati all'enucleazione.
La presentazione metterà in evidenza il potenziale impatto del darovasertib nella gestione della malattia, particolarmente rilevante poiché ha ricevuto la designazione di terapia innovativa (Breakthrough Therapy) dalla FDA per l'uso neoadiuvante nei pazienti con melanoma uveale che necessitano di enucleazione. L'azienda ha inoltre avviato nel terzo trimestre del 2025 lo studio globale di registrazione di Fase 3 neoadiuvante OptimUM-10.
IDEAYA Biosciences (NASDAQ:IDYA) anunció que los resultados de su estudio de Fase 2 sobre darovasertib neoadyuvante en melanoma uveal primario serán presentados en el ESMO 2025 en Berlín. El estudio incluye datos de más de 90 pacientes de las cohortes elegibles para braquiterapia con placa y enucleación.
La presentación destacará el potencial impacto del darovasertib en el manejo de la enfermedad, especialmente relevante ya que ha recibido la Designación de Terapia Innovadora (Breakthrough Therapy) de la FDA para su uso neoadyuvante en pacientes con melanoma uveal que requieren enucleación. La compañía también ha iniciado en el tercer trimestre de 2025 el ensayo global de registro de Fase 3 neoadyuvante OptimUM-10.
IDEAYA Biosciences (NASDAQ:IDYA)는 원발성 포도막 흑색종에 대한 신보조요법 다로바서티브의 2상 연구 결과를 ESMO 2025 베를린 학회에서 발표할 예정이라고 발표했습니다. 이 연구는 플라크 근접치료 및 안구 적출 대상 환자군을 포함하여 90명 이상의 환자 데이터를 포함합니다.
발표에서는 다로바서티브가 질병 관리에 미칠 잠재적 영향을 강조할 예정이며, 특히 안구 적출이 필요한 포도막 흑색종 환자에 대한 신보조요법으로 FDA 혁신 치료 지정(Breakthrough Therapy Designation)을 받은 점이 주목됩니다. 회사는 2025년 3분기에 글로벌 3상 신보조요법 등록 임상시험 OptimUM-10도 시작했습니다.
IDEAYA Biosciences (NASDAQ:IDYA) a annoncé que les résultats de leur étude de Phase 2 sur le darovasertib en néoadjuvant dans le mélanome uvéal primaire seront présentés lors de l'ESMO 2025 à Berlin. L'étude comprend des données de plus de 90 patients issus des cohortes éligibles à la brachythérapie par plaque et à l'énucléation.
La présentation mettra en lumière le potentiel impact du darovasertib sur la prise en charge de la maladie, particulièrement notable puisqu'il a obtenu la désignation de thérapie innovante (Breakthrough Therapy) de la FDA pour une utilisation en néoadjuvant chez les patients atteints de mélanome uvéal nécessitant une énucléation. L'entreprise a également lancé au troisième trimestre 2025 l'essai mondial d'enregistrement de Phase 3 en néoadjuvant OptimUM-10.
IDEAYA Biosciences (NASDAQ:IDYA) gab bekannt, dass die Ergebnisse ihrer Phase-2-Studie mit neoadjuvantem Darovasertib bei primärem Uveamelanom auf dem ESMO 2025 in Berlin vorgestellt werden. Die Studie umfasst Daten von über 90 Patienten aus den Kohorten für Platten-Brachytherapie und enukleationsberechtigte Patienten.
Die Präsentation wird das potenzielle Wirkungsspektrum von Darovasertib auf das Krankheitsmanagement hervorheben, besonders bemerkenswert, da es für die neoadjuvante Anwendung bei Uveamelanom-Patienten, die eine Enukleation benötigen, die FDA Breakthrough Therapy Designation erhalten hat. Das Unternehmen hat zudem im dritten Quartal 2025 die globale Phase-3-Studie OptimUM-10, eine neoadjuvante Zulassungsstudie, gestartet.
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Insights
IDEAYA's darovasertib shows promising potential in treating primary uveal melanoma with Phase 3 trial underway following FDA Breakthrough designation.
This announcement represents a significant milestone in IDEAYA's clinical development program for darovasertib in uveal melanoma (UM). The acceptance of their Phase 2 data for an oral presentation at ESMO 2025 is particularly noteworthy as oral presentations are typically reserved for studies with compelling results that warrant heightened attention from the scientific community.
The Phase 2 study encompasses over 90 patients across two critical cohorts: those eligible for plaque brachytherapy (a localized radiation treatment) and those requiring enucleation (surgical removal of the eye). This comprehensive approach addresses the full spectrum of primary UM patients, from those with potentially salvageable vision to those with more advanced disease.
Darovasertib has secured FDA Breakthrough Therapy Designation specifically for neoadjuvant use in patients who would otherwise require enucleation. This designation is not awarded lightly and suggests the preliminary data demonstrated substantial improvement over existing therapies in this setting where patients face loss of an eye.
The progression to a randomized Phase 3 registrational trial (OptimUM-10) indicates strong confidence in the drug's efficacy profile. The term "registrational" is particularly significant as it signals the company's intention to use this trial for regulatory approval submissions.
Most compelling is the title of the upcoming presentation which suggests darovasertib may enable "enucleation prevention and vision preservation" - outcomes that would dramatically improve the standard of care for UM patients. Currently, treatment options for primary UM are limited and often result in significant visual impairment or complete loss of the affected eye.
This neoadjuvant approach (treatment before primary intervention) represents an innovative strategy that could potentially transform the treatment paradigm for a rare but devastating cancer with historically poor outcomes.
- The presentation will include data from over 90 patients in both the plaque brachytherapy and enucleation-eligible cohorts
- Darovasertib has received
U.S. FDA Breakthrough Therapy Designation for use in neoadjuvant uveal melanoma for subjects requiring enucleation - Initiated a multi-site, global randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma (OptimUM-10) in Q3 2025
"We are excited to share clinical data at ESMO 2025 on the effects of neoadjuvant darovasertib in primary uveal melanoma across both plaque brachytherapy and enucleation cohorts. Its potential to impact the natural history of this disease and its management will be highlighted in the presentation. We continue to advance our clinical strategy for darovasertib in earlier stage disease, with the recent initiation of a randomized Phase 3 neoadjuvant registrational trial in primary uveal melanoma," said Dr. Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.
Details of the Proffered Paper Oral Presentation are as follows:
Title (Abstract #5053): Enucleation prevention and vision preservation in primary uveal melanoma (UM): preliminary results from a phase 2 study of neoadjuvant darovasertib
Presenter: Dr. Marcus
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small-molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of improving clinical outcomes for patients with cancer.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of darovasertib, and (ii) the timing and content of a presentation on the preliminary results from a Phase 2 study of neoadjuvant darovasertib in primary UM. 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 18, 2025 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
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