IDEAYA Announces First-Patient-In for Phase 1 Clinical Trial Evaluating IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer
IDEAYA Biosciences (Nasdaq:IDYA) has initiated its Phase 1 clinical trial by dosing the first patient with IDE161 in combination with KEYTRUDA® for endometrial cancer treatment. IDE161, a potential first-in-class PARG inhibitor, will be evaluated alongside Merck's anti-PD-1 therapy in patients with MSI-high and MSS endometrial cancer.
The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the combination therapy. IDE161 has received two FDA Fast Track designations for treating platinum-resistant ovarian cancer with BRCA1/2 mutations and pretreated HR+, Her2-, BRACA1/2 mutant breast cancer. The company has also selected an initial Phase 1/2 monotherapy expansion dose based on adverse event profile and preliminary clinical efficacy.
IDEAYA Biosciences (Nasdaq:IDYA) ha avviato il suo studio clinico di Fase 1 somministrando il trattamento a paziente con IDE161 in combinazione con KEYTRUDA® per il trattamento del cancro endometriale. IDE161, un potenziale inibitore di PARG di prima classe, sarà valutato insieme alla terapia anti-PD-1 di Merck in pazienti con cancro endometriale MSI-alto e MSS.
Lo studio valuterà la sicurezza, la tollerabilità, la farmacocinetica, la farmacodinamica e l'efficacia della terapia combinata. IDE161 ha ricevuto due designazioni di Fast Track dalla FDA per il trattamento del cancro ovarico resistente al platino con mutazioni BRCA1/2 e del cancro al seno HR+, Her2-, mutante BRCA1/2 già trattato. L'azienda ha anche selezionato una dose iniziale di espansione per monoterapia di Fase 1/2 basata sul profilo degli eventi avversi e sull'efficacia clinica preliminare.
IDEAYA Biosciences (Nasdaq:IDYA) ha iniciado su ensayo clínico de Fase 1 administrando el primer tratamiento con IDE161 en combinación con KEYTRUDA® para el tratamiento del cáncer endometrial. IDE161, un potencial inhibidor de PARG de primera clase, se evaluará junto con la terapia anti-PD-1 de Merck en pacientes con cáncer endometrial MSI-alto y MSS.
El ensayo evaluará la seguridad, la tolerabilidad, la farmacocinética, la farmacodinamia y la eficacia de la terapia combinada. IDE161 ha recibido dos designaciones de Fast Track de la FDA para tratar el cáncer de ovario resistente al platino con mutaciones BRCA1/2 y el cáncer de mama HR+, Her2-, mutante BRCA1/2 que ha sido previamente tratado. La empresa también ha seleccionado una dosis inicial de expansión de monoterapia de Fase 1/2 basada en el perfil de eventos adversos y la eficacia clínica preliminar.
IDEAYA Biosciences (Nasdaq:IDYA)는 KEYTRUDA®와 함께 IDE161을 투여하여 자궁내막암 치료를 위한 1상 임상 시험을 시작했습니다. IDE161은 잠재적인 첫 번째 PARG 억제제로, MSI-high 및 MSS 자궁내막암 환자에서 Merck의 항 PD-1 치료와 함께 평가됩니다.
이번 시험은 조합 요법의 안전성, 내약성, 약동학, 약력학 및 효능을 평가할 것입니다. IDE161은 BRCA1/2 변이가 있는 플래티넘 내성 난소암과 전처치된 HR+, Her2-, BRCA1/2 변이 유방암 치료를 위한 두 가지 FDA 패스트 트랙 지정을 받았습니다. 회사는 또한 부작용 프로필 및 초기 임상 효능을 기반으로 1/2상 단독요법 확장 용량을 선택했습니다.
IDEAYA Biosciences (Nasdaq:IDYA) a lancé son essai clinique de phase 1 en administrant le traitement au premier patient avec IDE161 en combinaison avec KEYTRUDA® pour le traitement du cancer de l'endomètre. IDE161, un inhibiteur de PARG potentiel de première classe, sera évalué aux côtés de la thérapie anti-PD-1 de Merck chez des patients atteints de cancer endométrial MSI-élevé et MSS.
L'essai évaluera la sécurité, la tolérance, la pharmacocinétique, la pharmacodynamique et l'efficacité de la thérapie combinée. IDE161 a reçu deux désignations Fast Track de la FDA pour le traitement du cancer de l'ovaire résistant au platine avec des mutations BRCA1/2 et du cancer du sein HR+, Her2-, mutant BRCA1/2 ayant déjà été traité. L'entreprise a également sélectionné une dose d'expansion initiale de monothérapie de phase 1/2 en fonction du profil des événements indésirables et de l'efficacité clinique préliminaire.
IDEAYA Biosciences (Nasdaq:IDYA) hat seine Phase-1-Studie gestartet und den ersten Patienten mit IDE161 in Kombination mit KEYTRUDA® zur Behandlung von Endometriumkarzinomen behandelt. IDE161, ein potenzieller erst-in-Klasse PARG-Hemmer, wird zusammen mit Mercks Anti-PD-1-Therapie bei Patienten mit MSI-hohem und MSS-Endometriumkarzinom bewertet.
Die Studie wird die Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und Wirksamkeit der Kombinationstherapie bewerten. IDE161 hat zwei Fast-Track-Zulassungen von der FDA zur Behandlung von platinsensiblen Eierstockkarzinomen mit BRCA1/2-Mutationen sowie zur Behandlung von zuvor behandelten HR+, Her2-, BRCA1/2-mutierten Brustkrebserkrankungen erhalten. Das Unternehmen hat außerdem eine anfängliche Phase-1/2-Dosenexpansionstherapie auf Grundlage des Nebenwirkungsprofils und der vorläufigen klinischen Wirksamkeit ausgewählt.
- First patient dosed in Phase 1 trial combining IDE161 with KEYTRUDA
- IDE161 has received two FDA Fast Track designations
- Initial Phase 1/2 monotherapy expansion dose selected based on preliminary efficacy
- None.
Insights
- First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy
- The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer
- Selected initial Phase 1/2 expansion dose for IDE161 monotherapy in a priority solid tumor type, based on AE profile and preliminary clinical efficacy observed
"We continue to progress our IDE161 program and are excited to have the first patient dosed evaluating IDE161 in combination with KEYTRUDA in MSI-high and MSS endometrial cancer patients. This trial is part of our overall IDE161 clinical combination strategy that is focused on high conviction rational combinations," commented Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
"We are continually looking for ways to improve outcomes for patients with MSI-high and MSS endometrial cancer, and PARG has shown promising potential as a precision oncology target in these settings. IDE161 has shown robust anti-tumor activity in preclinical models, and I look forward to evaluating IDE161's impact on endometrial cancer patients in combination with KEYTRUDA," added Dr. Panos Konstantinopoulos, M.D., Ph.D., Director of Translational Research and attending oncologist in the Division of Gynecologic Oncology at Dana-Farber Cancer Institute, and an Associate Professor of Medicine at Harvard Medical School.
IDE161 is a potential first-in-class inhibitor of poly(ADP-ribose) glycohydrolase (PARG), a novel, mechanistically distinct target in the same clinically validated biological pathway as poly(ADP-ribose) polymerase (PARP). IDE161 has been granted two FDA Fast Track designations in platinum-resistant advanced or metastatic ovarian cancer patients having tumors with BRCA1/2 mutations, and in pretreated advanced or metastatic HR+, Her2-, BRACA1/2 mutant breast cancer.
Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to IDEAYA, the sponsor of the Phase 1 clinical combination trial. IDEAYA and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.
The safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA is being evaluated as an arm in IDE161-001 (NCT05787587), an IDEAYA-sponsored Phase 1 trial of IDE161 in solid tumors. The selection of an initial Phase 1/2 monotherapy expansion dose has been made in a priority tumor type based on adverse event (AE) profile and preliminary clinical efficacy observed.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
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. IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related the potential therapeutic benefits of IDE161 in combination with KEYTRUDA. IDEAYA undertakes no obligation to update or revise any forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. For a further description of the risks and uncertainties that could cause actual events and 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 filed on February 20, 2024 and any current and periodic reports filed with the
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SOURCE IDEAYA Biosciences, Inc.
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