IDEAYA Announces Further Gilead Sciences Clinical Study Collaboration Evaluating Combination of Trodelvy® and IDE397 in MTAP-Deletion NSCLC
IDEAYA Biosciences (IDYA) has expanded its clinical collaboration with Gilead Sciences to evaluate IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy in MTAP-deletion non-small cell lung cancer (NSCLC). The combination targets two distinct mechanisms in MTAP-deletion solid tumors, with MTAP-deletion occurring in approximately 15% of NSCLC cases, representing a significant portion of the estimated 48,000 U.S. cases annually.
The study will expand the ongoing Phase 1 trial, which currently evaluates the combination in MTAP-deletion urothelial cancer. Under the agreement, both companies retain commercial rights to their respective compounds. IDEAYA will sponsor the study while Gilead provides Trodelvy supply. The company expects to provide clinical program updates in 2025.
IDEAYA Biosciences (IDYA) ha ampliato la sua collaborazione clinica con Gilead Sciences per valutare IDE397, un potenziale inibitore MAT2A di prima classe, in combinazione con il Trodelvy di Gilead nel carcinoma polmonare non a piccole cellule (NSCLC) con delezione di MTAP. La combinazione mira a colpire due meccanismi distinti nei tumori solidi con delezione di MTAP, che si verifica in circa il 15% dei casi di NSCLC, rappresentando una parte significativa dei circa 48.000 casi stimati negli Stati Uniti ogni anno.
Lo studio espanderà la fase 1 in corso, che attualmente valuta la combinazione nel carcinoma uroteliale con delezione di MTAP. Ai sensi dell'accordo, entrambe le aziende mantengono diritti commerciali sui rispettivi composti. IDEAYA sponsorizzerà lo studio mentre Gilead fornirà il rifornimento di Trodelvy. L'azienda prevede di fornire aggiornamenti sul programma clinico nel 2025.
IDEAYA Biosciences (IDYA) ha ampliado su colaboración clínica con Gilead Sciences para evaluar IDE397, un potencial inhibidor MAT2A de primera clase, en combinación con el Trodelvy de Gilead en cáncer de pulmón no microcítico (NSCLC) con deleción de MTAP. La combinación apunta a dos mecanismos distintos en tumores sólidos con deleción de MTAP, que ocurre en aproximadamente el 15% de los casos de NSCLC, representando una parte significativa de los aproximadamente 48,000 casos anuales estimados en EE. UU.
El estudio ampliará el ensayo de fase 1 en curso, que actualmente evalúa la combinación en cáncer urotelial con deleción de MTAP. Según el acuerdo, ambas compañías retienen derechos comerciales sobre sus respectivos compuestos. IDEAYA patrocinará el estudio mientras que Gilead proporcionará el suministro de Trodelvy. La compañía espera proporcionar actualizaciones del programa clínico en 2025.
IDEAYA Biosciences (IDYA)는 Gilead Sciences와의 임상 협력을 확대하여 MTAP 결실 비소세포 폐암(NSCLC)에서 Gilead의 Trodelvy와 병용하여 잠재적인 최초의 MAT2A 억제제인 IDE397을 평가하고 있습니다. 이 조합은 MTAP 결실 고형 종양에서 두 가지 독특한 메커니즘을 목표로 하며, MTAP 결실은 NSCLC 사례의 약 15%에서 발생하여 미국에서 연간 약 48,000건으로 추정되는 상당한 비율을 차지합니다.
이 연구는 현재 MTAP 결실 요로상피암에서의 조합을 평가하는 진행 중인 1상 시험을 확장할 것입니다. 계약에 따라 두 회사는 각자의 화합물에 대한 상업적 권리를 유지합니다. IDEAYA는 연구를 후원하고 Gilead는 Trodelvy 공급을 제공합니다. 이 회사는 2025년에 임상 프로그램 업데이트를 제공할 것으로 예상하고 있습니다.
IDEAYA Biosciences (IDYA) a élargi sa collaboration clinique avec Gilead Sciences pour évaluer IDE397, un potentiel inhibiteur MAT2A de première classe, en combinaison avec le Trodelvy de Gilead dans le cancer du poumon non à petites cellules (NSCLC) avec délétion de MTAP. La combinaison cible deux mécanismes distincts dans les tumeurs solides avec délétion de MTAP, qui se produit dans environ 15 % des cas de NSCLC, représentant une part significative des 48 000 cas estimés aux États-Unis chaque année.
L'étude va élargir l'essai de phase 1 en cours, qui évalue actuellement la combinaison dans le cancer urotélial avec délétion de MTAP. Selon l'accord, les deux entreprises conservent des droits commerciaux sur leurs composés respectifs. IDEAYA parrainera l'étude tandis que Gilead fournira l'approvisionnement en Trodelvy. L'entreprise prévoit de fournir des mises à jour sur le programme clinique en 2025.
IDEAYA Biosciences (IDYA) hat seine klinische Zusammenarbeit mit Gilead Sciences ausgeweitet, um IDE397, einen potenziellen erstklassigen MAT2A-Inhibitor, in Kombination mit Gileads Trodelvy bei MTAP-deletierten nicht-kleinzelligen Lungenkrebs (NSCLC) zu bewerten. Die Kombination zielt auf zwei unterschiedliche Mechanismen in MTAP-deletierten soliden Tumoren ab, wobei die MTAP-Deletion in etwa 15% der NSCLC-Fälle auftritt, was einen erheblichen Teil der geschätzten 48.000 Fälle in den USA jährlich darstellt.
Die Studie wird die laufende Phase-1-Studie erweitern, die derzeit die Kombination bei MTAP-deletiertem Urothelkarzinom bewertet. Gemäß der Vereinbarung behalten beide Unternehmen die kommerziellen Rechte an ihren jeweiligen Verbindungen. IDEAYA wird die Studie sponsern, während Gilead Trodelvy bereitstellt. Das Unternehmen erwartet, 2025 Updates zum klinischen Programm zu geben.
- Expansion of clinical collaboration with major pharma company Gilead Sciences
- Targeting significant market opportunity with 48,000 annual U.S. cases
- IDE397 shows potential as first-in-class treatment for MTAP-deletion tumors
- Multiple ongoing trials including monotherapy and combination studies
- IDE397 not yet approved by regulatory agencies
- Efficacy and safety of the combination therapy still unestablished
Insights
This clinical collaboration expansion represents a significant strategic advancement in precision oncology, particularly in targeting MTAP-deleted NSCLC. The combination of IDE397 and Trodelvy is especially noteworthy for several reasons:
- The dual-targeting approach addresses MTAP-deletion through two distinct mechanisms: IDE397's MAT2A inhibition and Trodelvy's Trop-2 directed antibody-drug conjugate activity. This complementary approach could potentially lead to enhanced therapeutic efficacy compared to single-agent treatments.
- With MTAP-deletion present in
15% of NSCLC cases (approximately 48,000 U.S. cases annually), this represents a substantial market opportunity. The targeted nature of the therapy aligns with the growing trend toward precision medicine in oncology. - Trodelvy's established success in breast cancer indications (approved in over 50 countries) provides validation for its efficacy as an ADC platform, potentially de-risking this new combination approach.
- IDEAYA's parallel development of IDE397 monotherapy and a planned combination with IDE892 (their PRMT5 inhibitor) demonstrates a comprehensive strategy to address MTAP-deleted tumors through multiple approaches.
The collaboration structure, where each company maintains rights to their respective compounds, is particularly advantageous as it allows both parties to maximize the value of their assets while sharing development costs and risks. The expansion of this trial suggests promising early signals from the ongoing urothelial cancer study, though specific efficacy data remains pending.
- Entered into an additional clinical study collaboration and supply agreement with Gilead to evaluate IDE397, IDEAYA's MAT2A inhibitor, in combination with Trodelvy, Gilead's Trop-2 directed ADC, in MTAP-deletion NSCLC
- The potential first-in-class clinical combination of IDE397 and Trodelvy targets two mechanistically distinct and complementary nodes of MTAP-deletion in solid tumors
- MTAP-deletion prevalence in NSCLC is estimated to be approximately
15%
"We are pleased to broaden the ongoing evaluation of the potential first-in-class clinical combination of IDE397 and Trodelvy to now include patients with MTAP-deletion NSCLC in our ongoing Phase 1 trial currently evaluating the combination in MTAP-deletion urothelial cancer. We are excited to continue to explore this potential first-in-class combination in MTAP-deletion solid tumors and look forward to providing clinical program updates in 2025," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with MTAP-deletion. The prevalence of MTAP-deletion is estimated to be approximately
Trodelvy is currently approved in 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.
In addition to the Phase 1/2 trial evaluating IDE397 in combination with Trodelvy in UC and NSCLC, IDEAYA is actively enrolling patients into a monotherapy expansion in MTAP-deletion NSCLC and urothelial cancer 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 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-announces-further-gilead-sciences-clinical-study-collaboration-evaluating-combination-of-trodelvy-and-ide397-in-mtap-deletion-nsclc-302375663.html
SOURCE IDEAYA Biosciences, Inc.
FAQ
What is the MTAP-deletion prevalence in NSCLC patients for IDYA's IDE397 treatment?
When will IDEAYA Biosciences provide clinical updates on the IDE397-Trodelvy combination?
What type of cancers will IDYA's IDE397 and Trodelvy combination target?
What is the current regulatory status of IDYA's IDE397 treatment?
What new clinical trial is IDEAYA planning for IDE397 in 2025?
