IDEAYA Biosciences Announces Phase 1/2 Expansion for IDE397 and Trodelvy® Combination in MTAP-Deletion Urothelial Cancer
IDEAYA Biosciences (IDYA) has initiated a Phase 1/2 expansion study evaluating the combination of IDE397, its MAT2A inhibitor, with Trodelvy® in MTAP-deletion urothelial cancer (UC). The expansion is based on preliminary safety and clinical efficacy data.
IDE397 is a potent and selective small molecule inhibitor targeting MAT2A in solid tumors with MTAP-deletion, which affects approximately 26% of UC patients. The combination represents a potential first-in-class treatment approach for MTAP-deletion UC, addressing an unmet medical need with no currently approved targeted therapies.
A clinical program update on the IDE397-Trodelvy combination is expected in 2025. Additionally, IDEAYA plans to initiate a combination trial of IDE397 with IDE892, their MTA-cooperative PRMT5 inhibitor, in the second half of 2025.
IDEAYA Biosciences (IDYA) ha avviato uno studio di espansione di Fase 1/2 che valuta la combinazione di IDE397, il suo inibitore MAT2A, con Trodelvy® nel cancro uroteliale (UC) con delezione di MTAP. L'espansione si basa su dati preliminari di sicurezza ed efficacia clinica.
IDE397 è un potente e selettivo inibitore a piccole molecole che colpisce MAT2A nei tumori solidi con delezione di MTAP, che interessa circa il 26% dei pazienti con UC. La combinazione rappresenta un potenziale approccio terapeutico innovativo per l'UC con delezione di MTAP, rispondendo a un bisogno medico non soddisfatto, poiché non ci sono attualmente terapie mirate approvate.
Un aggiornamento sul programma clinico relativo alla combinazione IDE397-Trodelvy è atteso nel 2025. Inoltre, IDEAYA prevede di avviare uno studio di combinazione di IDE397 con IDE892, il loro inibitore PRMT5 cooperativo MTA, nella seconda metà del 2025.
IDEAYA Biosciences (IDYA) ha iniciado un estudio de expansión de Fase 1/2 que evalúa la combinación de IDE397, su inhibidor de MAT2A, con Trodelvy® en cáncer urotelial (UC) con deleción de MTAP. La expansión se basa en datos preliminares de seguridad y eficacia clínica.
IDE397 es un potente y selectivo inhibidor de pequeñas moléculas que se dirige a MAT2A en tumores sólidos con deleción de MTAP, que afecta aproximadamente al 26% de los pacientes con UC. La combinación representa un enfoque terapéutico potencial innovador para el UC con deleción de MTAP, abordando una necesidad médica no satisfecha, ya que actualmente no hay terapias dirigidas aprobadas.
Se espera una actualización del programa clínico sobre la combinación IDE397-Trodelvy en 2025. Además, IDEAYA planea iniciar un ensayo de combinación de IDE397 con IDE892, su inhibidor de PRMT5 cooperativo de MTA, en la segunda mitad de 2025.
IDEAYA 바이오사이언스 (IDYA)는 MTAP 결실 유로텔리얼 암(UC)에서 IDE397와 Trodelvy®의 조합을 평가하는 1/2상 확장 연구를 시작했습니다. 이 확장은 초기 안전성 및 임상 효능 데이터에 기반하고 있습니다.
IDE397은 MTAP 결실이 있는 고형 종양의 MAT2A를 표적으로 하는 강력하고 선택적인 소분자 억제제입니다. 이는 UC 환자의 약 26%에 영향을 미칩니다. 이 조합은 MTAP 결실 UC에 대한 잠재적인 최초의 혁신적 치료 접근법을 나타내며, 현재 승인된 표적 치료제가 없어 충족되지 않은 의료적 필요를 다루고 있습니다.
IDE397-Trodelvy 조합에 대한 임상 프로그램 업데이트는 2025년에 예상됩니다. 또한, IDEAYA는 2025년 하반기에 IDE397과 그들의 MTA 협동 PRMT5 억제제인 IDE892의 조합 시험을 시작할 계획입니다.
IDEAYA Biosciences (IDYA) a lancé une étude d'expansion de Phase 1/2 évaluant la combinaison de IDE397, son inhibiteur de MAT2A, avec Trodelvy® dans le cancer urotélial (UC) avec délétion de MTAP. L'expansion est basée sur des données préliminaires de sécurité et d'efficacité clinique.
IDE397 est un inhibiteur puissant et sélectif de petites molécules ciblant MAT2A dans les tumeurs solides avec délétion de MTAP, qui touche environ 26% des patients atteints d'UC. La combinaison représente une approche thérapeutique potentiellement innovante pour l'UC avec délétion de MTAP, répondant à un besoin médical non satisfait, car il n'existe actuellement aucune thérapie ciblée approuvée.
Une mise à jour du programme clinique concernant la combinaison IDE397-Trodelvy est attendue en 2025. De plus, IDEAYA prévoit de lancer un essai de combinaison d'IDE397 avec IDE892, leur inhibiteur PRMT5 coopératif MTA, dans la seconde moitié de 2025.
IDEAYA Biosciences (IDYA) hat eine Phase 1/2-Erweiterungsstudie gestartet, die die Kombination von IDE397, seinem MAT2A-Inhibitor, mit Trodelvy® bei Urothelkarzinom (UC) mit MTAP-Deletion bewertet. Die Erweiterung basiert auf vorläufigen Sicherheits- und klinischen Wirksamkeitsdaten.
IDE397 ist ein potenter und selektiver Inhibitor kleiner Moleküle, der MAT2A in soliden Tumoren mit MTAP-Deletion angreift, was etwa 26% der UC-Patienten betrifft. Die Kombination stellt einen potenziellen neuartigen Therapieansatz für MTAP-deletiertes UC dar und erfüllt einen ungedeckten medizinischen Bedarf, da es derzeit keine zugelassenen zielgerichteten Therapien gibt.
Ein Update zum klinischen Programm zur Kombination IDE397-Trodelvy wird für 2025 erwartet. Darüber hinaus plant IDEAYA, in der zweiten Hälfte von 2025 eine Kombinationstestung von IDE397 mit IDE892, ihrem MTA-kooperativen PRMT5-Inhibitor, zu starten.
- Expansion to Phase 1/2 based on positive preliminary safety and efficacy data
- Addresses large market opportunity with 26% of UC patients having MTAP-deletion
- First-in-class potential for IDE397-Trodelvy combination in MTAP-deletion UC
- Clear development pathway with multiple expansion opportunities
- IDE397 not yet approved by regulatory agencies
- Faces competition from existing UC treatments
- Clinical efficacy data still preliminary
Insights
IDEAYA's advancement to a Phase 1/2 expansion for IDE397 combined with Trodelvy in MTAP-deletion urothelial cancer represents meaningful clinical progress in a space with significant unmet need. The decision to expand based on preliminary safety and efficacy signals is particularly noteworthy, suggesting the early data has shown promise worth pursuing further.
The targeted approach is scientifically sound - IDE397 inhibits MAT2A, which exploits a synthetic lethality vulnerability created by MTAP deletion. With
The partnership with Gilead leverages Trodelvy's established mechanism as an antibody-drug conjugate targeting Trop-2, potentially creating synergistic effects with IDE397. While Trodelvy is already approved in breast cancer indications, its application in urothelial cancer remains investigational.
The planned update later this year will be critical for assessing the durability of response and confirming the preliminary signals that prompted this expansion. IDEAYA's parallel development of IDE892 (a PRMT5 inhibitor) for combination with IDE397 demonstrates strategic depth in their synthetic lethality platform and provides multiple shots on goal for this molecular target.
This Phase 1/2 expansion marks a significant derisking event for IDEAYA's lead synthetic lethality program. Moving to an expansion cohort indicates the preliminary data cleared key safety hurdles while showing sufficient efficacy signals to justify further investment. For a precision oncology biotech, each clinical milestone that validates their scientific platform carries outsized importance.
The strategic collaboration with Gilead provides multiple advantages: shared development costs, access to an established ADC therapy, and validation from a major pharmaceutical partner while maintaining full commercial rights to IDE397. This capital-efficient approach extends IDEAYA's runway while advancing their pipeline.
The MTAP-deletion focus represents savvy market positioning. With
Importantly, the planned initiation of an IDE397/IDE892 combination study highlights IDEAYA's evolving into a platform company rather than a single-asset biotech, significantly reducing binary risk. This expansion, while early-stage, represents a meaningful step toward clinical validation of IDEAYA's synthetic lethality approach with multiple potential commercialization pathways.
- Initiated Phase 1/2 study expansion for IDE397, IDEAYA's MAT2A inhibitor, in combination with Trodelvy®, Gilead's Trop-2 directed ADC, in MTAP-deletion urothelial cancer based on preliminary safety and clinical efficacy data
- MTAP-deletion prevalence in urothelial cancer is estimated to be approximately
26%
IDE397 is a potent and selective small molecule inhibitor targeting (MAT2A), in patients having solid tumors with MTAP-deletion. The prevalence of MTAP-deletion is estimated to be approximately
"We are pleased to advance the potential first-in-class clinical combination of IDE397 and Trodelvy into an initial Phase 1/2 expansion in MTAP-deletion UC based on preliminary safety and clinical efficacy observed. We are excited to continue to explore this novel combination given the high unmet medical need, as there are no approved therapies specifically for MTAP-deletion UC," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. The use of Trodelvy in MTAP-deletion UC is investigational, and the safety and efficacy of this use have not been established.
A clinical program update on the IDE397 and Trodelvy combination is planned in 2025. In addition to the clinical trial program evaluating IDE397 in combination with Trodelvy, IDEAYA is has a monotherapy expansion study in MTAP-deletion NSCLC and UC and is expecting to initiate a wholly-owned clinical combination trial of IDE397 and IDE892, IDEAYA's potential best-in-class, MTA-cooperative PRMT5 inhibitor in the second half of 2025.
Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA.
IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.
Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.
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 (i) the prevalence of MTAP-deletion and (ii) the potential therapeutic benefits of the combination of IDE397 and Trodelvy. 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
Andres Ruiz Briseno
Chief Accounting Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
FAQ
What is the significance of IDEAYA's Phase 1/2 expansion study for IDE397 and Trodelvy in urothelial cancer?
What percentage of urothelial cancer patients could benefit from IDYA's IDE397 treatment?
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How does the commercial agreement between IDYA and Gilead work for the IDE397-Trodelvy combination?
