LOS ANGELES - Puma Biotechnology, Inc. (NASDAQ:PBYI) has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with a Phase II clinical trial for its investigational drug alisertib, intended for patients with a specific type of metastatic breast cancer.
The trial, named ALISCA-Breast1 (Study PUMA-ALI-4201), is set to begin in the second half of 2024 and will focus on individuals with hormone receptor-positive, HER2-negative metastatic breast cancer who have previously undergone certain treatments.
The ALISCA-Breast1 trial will explore the effectiveness of alisertib in combination with endocrine therapy, which includes drugs such as anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen. Eligible participants are those who have not been treated with chemotherapy but have received at least two prior lines of endocrine therapy and CDK 4/6 inhibitors in the metastatic setting.
Alisertib will be administered in varying doses ranging from 30 mg to 50 mg twice daily on a specified schedule within a 28-day cycle, alongside an endocrine therapy selected by the investigator. The trial aims to enroll up to 50 patients per dose level, with the primary efficacy endpoints being the objective response rate, duration of response, disease control rate, and progression-free survival.
Moreover, the study will assess the efficacy of alisertib within biomarker subgroups to potentially improve treatment outcomes based on previous preclinical and clinical findings.
Following the determination of an optimal dose, Puma Biotechnology plans to consult with global regulatory agencies to design a pivotal Phase III trial. The proposed Phase III trial would compare alisertib plus endocrine therapy against a placebo combined with endocrine therapy.
Alisertib has shown promise in previous studies, including the TBCRC 041 trial published in March 2023, which indicated its potential as a targeted therapy for metastatic breast cancer resistant to endocrine and CDK 4/6 inhibitor treatments.
Puma Biotechnology, known for its focus on cancer care enhancement, holds the development and commercialization rights to several drugs, including neratinib, which received FDA approval in 2017 and 2020 for specific breast cancer treatments. The company has previously initiated a Phase II trial for alisertib as monotherapy in small cell lung cancer.
The information in this article is based on a press release statement from Puma Biotechnology.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.