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Puma Biotechnology to Present Clinical Data on Neratinib at the AACR Annual Meeting 2025

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Puma Biotechnology (NASDAQ: PBYI) has announced the upcoming presentation of clinical data for neratinib at the AACR Annual Meeting 2025 in Chicago. The presentation will feature results from a Phase I trial investigating the combination of trastuzumab deruxtecan with neratinib in solid tumors with HER2 alterations (NCI 10495).

The poster presentation, led by Dr. Andrew Davis from Washington University School of Medicine, is scheduled for April 28, 2025, from 2:00-5:00 p.m. CT during the First-in-Human Phase I Clinical Trials session. The complete poster will be made available on Puma's website simultaneously with the live presentation.

Puma Biotechnology (NASDAQ: PBYI) ha annunciato la prossima presentazione dei dati clinici per neratinib durante il AACR Annual Meeting 2025 a Chicago. La presentazione presenterà i risultati di un trial di Fase I che indaga la combinazione di trastuzumab deruxtecan con neratinib in tumori solidi con alterazioni di HER2 (NCI 10495).

La presentazione del poster, guidata dal Dr. Andrew Davis della Washington University School of Medicine, è programmata per il 28 aprile 2025, dalle 14:00 alle 17:00 CT durante la sessione dei Trial Clinici di Fase I First-in-Human. Il poster completo sarà reso disponibile sul sito web di Puma contemporaneamente alla presentazione dal vivo.

Puma Biotechnology (NASDAQ: PBYI) ha anunciado la próxima presentación de datos clínicos para neratinib en la AACR Annual Meeting 2025 en Chicago. La presentación contará con los resultados de un ensayo de Fase I que investiga la combinación de trastuzumab deruxtecan con neratinib en tumores sólidos con alteraciones de HER2 (NCI 10495).

La presentación del póster, liderada por el Dr. Andrew Davis de la Washington University School of Medicine, está programada para el 28 de abril de 2025, de 2:00 a 5:00 p.m. CT durante la sesión de Ensayos Clínicos de Fase I First-in-Human. El póster completo estará disponible en el sitio web de Puma simultáneamente con la presentación en vivo.

푸마 생명공학 (NASDAQ: PBYI)는 시카고에서 열리는 AACR 연례 회의 2025에서 neratinib에 대한 임상 데이터 발표를 예고했습니다. 이 발표는 HER2 변이가 있는 고형 종양에서 trastuzumab deruxtecan과 neratinib의 조합을 조사하는 1상 시험의 결과를 특징으로 합니다 (NCI 10495).

워싱턴 대학교 의과대학의 앤드류 데이비스 박사가 이끄는 포스터 발표는 2025년 4월 28일 오후 2시부터 5시까지 CT 동안 First-in-Human 1상 임상 시험 세션에서 예정되어 있습니다. 포스터 전체는 생중계 발표와 동시에 푸마의 웹사이트에서 제공될 것입니다.

Puma Biotechnology (NASDAQ: PBYI) a annoncé la prochaine présentation de données cliniques pour le neratinib lors de la AACR Annual Meeting 2025 à Chicago. La présentation mettra en avant les résultats d'un essai de Phase I étudiant la combinaison de trastuzumab deruxtecan avec neratinib dans des tumeurs solides avec des altérations de HER2 (NCI 10495).

La présentation de l'affiche, dirigée par le Dr. Andrew Davis de la Washington University School of Medicine, est prévue pour le 28 avril 2025, de 14h00 à 17h00 CT lors de la session des essais cliniques de Phase I First-in-Human. L'affiche complète sera mise à disposition sur le site Web de Puma en même temps que la présentation en direct.

Puma Biotechnology (NASDAQ: PBYI) hat die bevorstehende Präsentation klinischer Daten zu Neratinib auf dem AACR Annual Meeting 2025 in Chicago angekündigt. Die Präsentation wird Ergebnisse aus einer Phase-I-Studie zur Kombination von Trastuzumab Deruxtecan mit Neratinib bei soliden Tumoren mit HER2-Änderungen (NCI 10495) zeigen.

Die Posterpräsentation, geleitet von Dr. Andrew Davis von der Washington University School of Medicine, ist für den 28. April 2025, von 14:00 bis 17:00 Uhr CT während der Sitzung zu First-in-Human Phase-I-Studien geplant. Das vollständige Poster wird gleichzeitig mit der Live-Präsentation auf der Website von Puma verfügbar sein.

Positive
  • Phase I trial data presentation at major cancer research conference indicates progress in clinical development
  • Investigation of combination therapy could potentially expand neratinib's applications
Negative
  • Early-stage Phase I trial indicates long development timeline ahead
  • No efficacy or safety data disclosed in the announcement

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that clinical data on neratinib will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting will be held at the McCormick Place in Chicago, Illinois, from April 25–30, 2025. The title of the poster that will be presented is now available on the AACR Annual Meeting website at https://www.abstractsonline.com/pp8/#!/20273/presentation/10447. The full poster will be available on the Puma website concurrent with the live presentation.

Poster Session: First-in-Human Phase I Clinical Trials 1

  • Abstract CT071: Title: Phase I trial of trastuzumab deruxtecan in combination with neratinib in solid tumors with HER2 alterations (NCI 10495)
    Authors: Andrew A. Davis, Haeseong Park, Ecaterina E. Dumbrava, Nataliya V. Uboha, Aparna Kalyan, Farshid Dayyani, Mili Arora, Miguel A. Villalona-Calero, Haider S. Mahdi, Reema A. Patel, Floor Backes, Jessica Porzel, Whitney L. Hensing, Cheryl Pickett, Cynthia X. Ma, Ron Bose
    Presenter: Andrew Davis, MD, Washington University School of Medicine
    Date/Time: April 28, 2025, 2:00–5:00 p.m. CT

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc.

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

info@pumabiotechnology.com

ir@pumabiotechnology.com



David Schull or Olipriya Das, Russo Partners, +1 212 845 4200

david.schull@russopartnersllc.com

olipriya.das@russopartnersllc.com

Source: Puma Biotechnology, Inc.

FAQ

What will be presented at the AACR 2025 meeting regarding PBYI's neratinib?

A Phase I trial studying the combination of trastuzumab deruxtecan with neratinib in solid tumors with HER2 alterations will be presented.

When and where is PBYI's neratinib presentation scheduled at AACR 2025?

The presentation is scheduled for April 28, 2025, from 2:00-5:00 p.m. CT at McCormick Place in Chicago.

What type of cancer patients are included in PBYI's Phase I trial?

The trial includes patients with solid tumors that have HER2 alterations.

Who is presenting the neratinib clinical data for PBYI at AACR 2025?

Dr. Andrew Davis from Washington University School of Medicine will present the data.
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