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

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.

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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.