Puma Biotechnology Announces Publication of Abstracts on Neratinib for the 2021 ASCO Annual Meeting

Rhea-AI Summary

Puma Biotechnology, Inc. (NASDAQ: PBYI) recently announced the publication of three abstracts on its drug neratinib, to be presented at the 2021 ASCO Annual Meeting from June 4-8. The abstracts focus on the drug's effectiveness in treating early-stage HER2+ breast cancer and non-small cell lung cancer. The presentations include findings from the ExteNET trial and the SUMMIT basket trial, highlighting treatment duration and tolerability issues related to diarrhea. The full posters will be accessible online from June 4, 2021.

Positive

• Three abstracts on neratinib published for ASCO 2021, indicating ongoing research and potential for increased visibility.
• Presentation of findings from key trials (ExteNET and SUMMIT) may enhance credibility and investor confidence.

Negative

• None.

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of three abstracts on neratinib for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. Puma will present three posters with audio recordings, the corresponding abstracts of which are now live on the 2021 ASCO Annual Meeting website. The full posters will be available on the Puma and ASCO websites at approximately 9:00 a.m. EDT on June 4, 2021.

Poster Session: Breast Cancer—Local/Regional/Adjuvant

• Abstract 540: Association between treatment duration and overall survival in early-stage HER2+ breast cancer patients receiving extended adjuvant therapy with neratinib in the ExteNET trial.
  B Moy, M Takahashi, S Ohtani, E Chmielowska, N Yamamoto, B Coudert, F Xu, A Wong, A Chan

• Abstract 536: Dose escalation for mitigating diarrhea: Ranked tolerability assessment of antidiarrheal regimens in patients receiving neratinib for early-stage breast cancer.
  G Marx, AJ Chien, JA García-Sáenz, A Chan, M Ruiz-Borrego, CH Barcenas, M Thirlwell, M Trudeau, R Bose, D Egle, B Pistilli, J Wasserman, KA Cheong, D Semsek, C Singer, D Hunt, U Khambholja, F Xu, N Shah, A Brufsky

Poster Session: Lung Cancer—Non-Small Cell Metastatic

• Abstract 9068: Neratinib efficacy in a subgroup of patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC) and central nervous system (CNS) involvement: findings from the SUMMIT basket trial.
  JW Goldman, SV Ramírez, A Mahipal, JM Suga, LD Eli, AS Lalani, R Bryce, F Xu, N Shah, F Kabbinavar, V Boni, B Haley

The abstracts are available online at: asco.org/abstracts

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-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. 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.

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

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FAQ

What are the key findings presented by Puma Biotechnology at ASCO 2021 related to neratinib?

Puma Biotechnology is presenting three abstracts focused on neratinib at ASCO 2021, including treatment duration effects in HER2+ breast cancer and tolerability assessments for diarrhea.

When will the abstracts on neratinib be available for viewing?

The abstracts are available online as of June 4, 2021, at the ASCO meeting website.

What is neratinib used for according to Puma Biotechnology's recent announcements?

Neratinib is used for the extended adjuvant treatment of early-stage HER2-overexpressed breast cancer and for advanced HER2-positive breast cancer in combination with capecitabine.

What trials are referenced in Puma Biotechnology's ASCO 2021 abstracts?

The abstracts reference findings from the ExteNET trial and the SUMMIT basket trial.

Is Puma Biotechnology's neratinib currently approved for use?

Yes, neratinib has been approved by the FDA for specific breast cancer treatments since 2017.