Puma Biotechnology, Inc., a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application concerning alisertib. This allows Puma to progress with clinical trials for treating patients with human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer in the Phase II ALISCA-Breast1 trial (Study PUMA-ALI-4201).

The trial aims to assess the effectiveness of alisertib in combination with various endocrine treatments in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer. Eligible patients must have previously undergone treatment with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.

Patients will receive alisertib at doses of 30 mg, 40 mg, or 50 mg twice daily on specified days within a 28-day cycle, alongside the investigator's chosen endocrine therapy. Biomarker evaluation will be facilitated through blood samples and tissue-based biopsies. The primary efficacy endpoints will include objective response rate, duration of response, disease control rate, and progression-free survival. Additionally, the Company plans to assess these endpoints within biomarker subgroups to potentially enhance alisertib's efficacy.

Upon identifying the optimal alisertib dose, Puma intends to engage with regulatory agencies globally to design a pivotal Phase III trial. This trial is expected to compare alisertib plus endocrine therapy versus placebo plus endocrine therapy in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer patients.

Alvin Wong, Pharm.D., Chief Scientific Officer of Puma Biotechnology, emphasized the need for new treatments targeting patients previously treated with CDK 4/6 inhibitors. He referenced the TBCRC 041 trial, which demonstrated promising clinical activity and tolerability of alisertib in endocrine and CDK 4/6 inhibitor resistant metastatic breast cancer.

Alan H. Auerbach, CEO and President of Puma Biotechnology, expressed enthusiasm for advancing alisertib's development in HER2-negative hormone receptor-positive metastatic breast cancer. He highlighted data from previous trials demonstrating alisertib's activity in this patient population and affirmed the Company's commitment to managing development expenses responsibly.

 

Source: businesswire.com

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