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Puma Biotechnology Advances Clinical Development of Alisertib in Lung and Breast Cancer

• Puma Biotechnology has launched two Phase II clinical trials for alisertib, targeting extensive-stage small cell lung cancer as monotherapy and HER2-negative HR-positive metastatic breast cancer in combination with endocrine therapy.

• The company's expansion into alisertib development follows their success with NERLYNX (neratinib), which is FDA-approved for HER2-positive breast cancer in both early-stage and metastatic settings.

• Alisertib, an oral aurora kinase A inhibitor, represents Puma's strategic expansion in oncology, with the company securing exclusive development and commercialization rights in September 2022.

Puma Biotechnology has expanded its oncology pipeline with the advancement of alisertib, launching two significant Phase II clinical trials for lung and breast cancer indications. The biopharmaceutical company initiated the ALISCA™-Lung1 trial in February 2024, evaluating alisertib as a monotherapy for extensive-stage small cell lung cancer patients.
Building on this momentum, the company launched ALISCA™-Breast1 in November 2024, investigating alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive metastatic breast cancer. These developments mark important milestones in Puma's strategic expansion of its cancer treatment portfolio.

Strategic Expansion in Oncology

Alisertib, acquired through an exclusive license agreement in September 2022, represents a significant addition to Puma's oncology pipeline. The drug is a selective, small molecule, orally administered inhibitor of aurora kinase A, offering a novel mechanism of action in cancer treatment.

Building on Established Success

This expansion follows Puma's successful development of NERLYNX® (neratinib), which has secured multiple regulatory approvals. NERLYNX received FDA approval in 2017 for extended adjuvant treatment of early-stage HER2-positive breast cancer following trastuzumab-based therapy. The drug's indication was expanded in February 2020 to include combination therapy with capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2-based regimens.

Global Market Presence

The company's global reach is evidenced by NERLYNX's marketing authorization from the European Commission in 2018 for early-stage hormone receptor-positive HER2-positive breast cancer patients. This approval specifically targets patients less than one year from completing prior adjuvant trastuzumab-based therapy.

Corporate Growth

As part of its continued growth, Puma recently granted inducement awards to new employees, including restricted stock unit awards vesting over three years. This move reflects the company's commitment to attracting and retaining talent as it advances its clinical development programs.
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