IDEAYA Biosciences Announces First-Patient-In for Phase 1/2 Combination Trial of IDE397, A Potential First-in-Class MAT2A Inhibitor, and Trodelvy® in MTAP-Deletion Non-Small Cell Lung Cancer
IDEAYA Biosciences (NASDAQ:IDYA) has announced the enrollment of its first non-small cell lung cancer (NSCLC) patient in the Phase 1/2 combination trial of IDE397 and Trodelvy®. The trial, conducted in collaboration with Gilead, evaluates this novel combination in patients with MTAP-deletion solid tumors.
Following encouraging preliminary data in bladder cancer, the trial has expanded into NSCLC, where MTAP-deletion occurs in up to 20% of cases. IDE397 is being developed as a potential first-in-class MAT2A inhibitor, while Trodelvy® is an established Trop2-directed antibody-drug conjugate. Under the collaboration agreement, IDEAYA maintains study sponsorship while Gilead provides Trodelvy supply, with both companies retaining commercial rights to their respective compounds.
IDEAYA Biosciences (NASDAQ:IDYA) ha comunicato l'arruolamento del primo paziente con carcinoma polmonare non a piccole cellule (NSCLC) nello studio di fase 1/2 che combina IDE397 e Trodelvy®. Lo studio, svolto in collaborazione con Gilead, valuta questa nuova combinazione in pazienti con tumori solidi con delezione di MTAP.
Dopo risultati preliminari promettenti nel carcinoma vescicale, lo studio è stato esteso all'NSCLC, dove la delezione di MTAP è presente fino al 20% dei casi. IDE397 viene sviluppato come possibile primo in classe inibitore di MAT2A, mentre Trodelvy® è un noto coniugato anticorpo-farmaco diretto contro Trop2. In base all'accordo di collaborazione, IDEAYA resta sponsor dello studio e Gilead fornisce Trodelvy®, con entrambe le società che mantengono i diritti commerciali sui rispettivi composti.
IDEAYA Biosciences (NASDAQ:IDYA) ha anunciado la inscripción del primer paciente con cáncer de pulmón no microcítico (NSCLC) en el ensayo de fase 1/2 que combina IDE397 y Trodelvy®. El ensayo, realizado en colaboración con Gilead, evalúa esta nueva combinación en pacientes con tumores sólidos con deleción de MTAP.
Tras datos preliminares alentadores en cáncer de vejiga, el estudio se ha ampliado al NSCLC, donde la deleción de MTAP aparece en hasta el 20% de los casos. IDE397 se desarrolla como posible inhibidor de MAT2A, primer representante de su clase, mientras que Trodelvy® es un conjugado anticuerpo-fármaco dirigido a Trop2 ya establecido. Según el acuerdo de colaboración, IDEAYA mantiene la condición de patrocinador del estudio y Gilead suministra Trodelvy®, y ambas compañías conservan los derechos comerciales sobre sus respectivos compuestos.
IDEAYA Biosciences (NASDAQ:IDYA)가 IDE397과 Trodelvy® 병용의 제1/2상 임상시험에 비소세포폐암(NSCLC) 첫 환자 등록을 발표했습니다. 길리어드와의 협력으로 진행되는 이 시험은 MTAP 결손 고형암 환자에서 이 새로운 병용요법을 평가합니다.
방광암에서의 고무적인 초기 결과를 바탕으로 연구가 NSCLC로 확대되었으며, 이 암종에서는 MTAP 결손이 최대 20%까지 발생합니다. IDE397은 잠재적 첫 번째 계열의 MAT2A 억제제로 개발 중이며, Trodelvy®는 Trop2 표적 항체-약물 접합체로 널리 사용되고 있습니다. 협력 계약에 따라 IDEAYA가 연구 스폰서 역할을 유지하고 길리어드는 Trodelvy®를 공급하며, 양사는 각자의 약물에 대한 상업적 권리를 보유합니다.
IDEAYA Biosciences (NASDAQ:IDYA) a annoncé l'inclusion du premier patient atteint d'un cancer du poumon non à petites cellules (NSCLC) dans l'essai de phase 1/2 combinant IDE397 et Trodelvy®. L'étude, menée en collaboration avec Gilead, évalue cette nouvelle combinaison chez des patients présentant des tumeurs solides avec délétion de MTAP.
Après des données préliminaires encourageantes dans le cancer de la vessie, l'essai s'est étendu au NSCLC, où la délétion de MTAP survient jusqu'à 20 % des cas. IDE397 est développé comme un inhibiteur de MAT2A potentiellement « first‑in‑class », tandis que Trodelvy® est un conjugué anticorps‑médicament dirigé contre Trop2 déjà établi. Dans le cadre de l'accord de collaboration, IDEAYA reste le promoteur de l'étude et Gilead fournit Trodelvy®, les deux sociétés conservant les droits commerciaux sur leurs composés respectifs.
IDEAYA Biosciences (NASDAQ:IDYA) hat die Einschreibung des ersten Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) in die Phase‑1/2‑Kombinationsstudie von IDE397 und Trodelvy® bekanntgegeben. Die in Zusammenarbeit mit Gilead durchgeführte Studie prüft diese neuartige Kombination bei Patientinnen und Patienten mit MTAP‑Deletion in soliden Tumoren.
Aufbauend auf vielversprechenden vorläufigen Daten beim Blasenkrebs wurde die Studie auf NSCLC ausgeweitet, wo eine MTAP‑Deletion in bis zu 20 % der Fälle vorkommt. IDE397 wird als potenzieller first‑in‑class MAT2A‑Inhibitor entwickelt, während Trodelvy® ein etabliertes Trop2‑gerichtetes Antikörper‑Wirkstoff‑Konjugat ist. Laut Kooperationsvereinbarung bleibt IDEAYA Studiensponsor, Gilead stellt Trodelvy® zur Verfügung, und beide Unternehmen behalten die kommerziellen Rechte an ihren jeweiligen Wirkstoffen.
- Expansion of clinical trial into NSCLC represents significant market opportunity with MTAP-deletion present in up to 20% of cases
- Encouraging preliminary data from bladder cancer cohort supports expansion strategy
- Strategic collaboration with Gilead enhances development capabilities while maintaining commercial rights
- IDE397 and its combination with Trodelvy remain unapproved by regulatory agencies
- Safety and efficacy of the combination therapy has not yet been established
- Targeting a competitive space with no currently approved targeted therapies for MTAP-deletion
Insights
IDEAYA advances potential first-in-class MAT2A inhibitor into NSCLC trials, targeting the underserved MTAP-deletion population affecting up to 20% of cases.
IDEAYA Biosciences has reached an important clinical milestone by dosing the first NSCLC patient in their Phase 1/2 combination trial of IDE397 and Trodelvy. This expansion builds upon their ongoing work in MTAP-deleted urothelial cancer and represents strategic pipeline advancement in precision oncology.
The scientific rationale behind this combination is particularly compelling. IDE397 targets MAT2A, an enzyme in the methionine pathway that becomes a critical vulnerability in MTAP-deleted tumors. When combined with Trodelvy, which delivers a topoisomerase inhibitor payload to Trop2-expressing cancer cells, this approach could potentially offer synergistic anti-tumor effects in a genetically-defined patient population.
What makes this development especially significant is that MTAP deletion occurs in approximately 20% of NSCLC cases, representing a substantial unaddressed market with no approved targeted therapies. The collaboration between IDEAYA and Gilead strategically leverages each company's expertise - IDEAYA's precision medicine platform focused on synthetic lethality and Gilead's established ADC technology.
While specific efficacy data isn't disclosed in this announcement, the companies' decision to expand into NSCLC suggests they've observed encouraging preliminary signals in the urothelial cancer cohort. The retention of respective commercial rights by both companies indicates confidence in the potential commercial value of this combination.
"We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort. This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.
"MTAP-deletion is found in up to
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.
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 NSCLC and UC is investigational, and the safety and efficacy of this use have not been established. 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, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and 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 the potential therapeutic benefits of IDE397and Trodelvy combination. 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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FAQ
What is the significance of IDEAYA's Phase 1/2 trial expansion for IDE397 and Trodelvy in NSCLC?
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