US-based biopharmaceutical company Puma Biotechnology has unveiled the design for the Phase II PUMA-ALI-1201 clinical trial of alisertib to treat patients with HER2-negative, hormone receptor-positive metastatic breast cancer.
Following talks with the US Food and Drug Administration (FDA), the company will begin a trial of alisertib plus endocrine treatment in patients with chemotherapy-naïve breast cancer patients.
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The endocrine treatment comprises either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen.
To be eligible for the trial, patients must have previously received treatment with CDK 4/6 inhibitors and a minimum of two lines of endocrine therapy in the recurrent or metastatic setting.
Puma Biotechnology intends to begin the trial in the second half of next year.
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In the trial, subjects will be given either 30mg, 40mg or 50mg doses of alisertib twice a day (BID) on days 1-3, 8-10 and 15-17 on a 28-day cycle together with investigator-selected endocrine therapy.
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By GlobalDataUp to 50 subjects will be enrolled in each dose level.
Objective response rate, duration of response, disease control rate and progression-free survival will be the trial’s primary efficacy endpoints.
Puma Biotechnology chief scientific officer Alvin Wong said: “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer.
“The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
Puma said it believes the trial design will meet the FDA’s Project Optimus for determining the most suitable dose of alisertib plus endocrine therapy for HER2-negative, hormone receptor-positive metastatic breast cancer to advance to a Phase III trial.
Once it has identified the optimal dose of alisertib, the company will hold talks with other regulatory authorities across the globe on the Phase III trial design.
