Puma Biotechnology Announces Phase II Clinical Trial Design For Alisertib In HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer; Plans To Initiate Trial In H2 2024

Author: Benzinga Newsdesk | December 11, 2023 09:32am

Patients will be dosed with alisertib given at either 30 mg, 40 mg or 50 mg twice daily (BID) on days 1-3, 8-10 and 15-17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial. Each dose level will enroll up to 50 patients. Patients must provide blood samples and tissue-based biopsies so that biomarkers can be evaluated. The primary efficacy end points will include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS). As a secondary objective, the Company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in preclinical and clinical studies in other cancers including breast cancer and small cell lung cancer. The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.

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