NEW YORK – Puma Biotechnology on Tuesday said the US Food and Drug Administration cleared its investigational new drug application, allowing it to begin a Phase II trial of the aurora kinase A (AURKA) inhibitor alisertib in small cell lung cancer.
Researchers will evaluate alisertib monotherapy in up to 60 patients with extensive-stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. They will also collect tissue samples from the participants for biomarker analysis.
The primary endpoint in the trial, slated to begin in the second half of 2023, is objective response rate; secondary endpoints are duration of response, disease control rate, progression-free survival, and overall survival. The researchers will evaluate each endpoint in pre-specified biomarker groups to determine if any subgroup derives increased benefit from alisertib. The firm did not disclose the specific biomarker subgroups it will include in the trial.
"The results from the previous clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib," Taofeek Owonikoko, chief of the division of hematology/oncology at the University of Pittsburgh Medical Center's Hillman Cancer Center, said in a statement.
While the firm did not specify which biomarkers it will focus on in this alisertib monotherapy trial, researchers have previously reported that in a Phase II study comparing the AURKA inhibitor plus paclitaxel against just paclitaxel, patients whose tumors had c-Myc expression and mutations in cell cycle regulators may benefit more from the addition of alisertib in the second-line setting.
Los Angeles-based Puma is also studying alisertib with chemo in hormone receptor (HR)-positive, HER2-negative breast cancer and in triple-negative breast cancer.