Journal article
Alpelisib Monotherapy for PI3K-Altered, Pretreated Advanced Breast Cancer: A Phase II Study
P Savas, LL Lo, SJ Luen, EF Blackley, J Callahan, K Moodie, CT van Geelen, YA Ko, CF Weng, L Wein, MJ Silva, AZ Bujak, MM Yeung, S Ftouni, RJ Hicks, PA Francis, CK Lee, SJ Dawson, S Loi
Cancer Discovery | Published : 2022
Abstract
There is limited knowledge on the benefit of the α-subunit–specific PI3K inhibitor alpe-lisib in later lines of therapy for advanced estrogen receptor–positive (ER+) HER2− and triple-negative breast cancer (TNBC). We conducted a phase II multicohort study of alpelisib monotherapy in patients with advanced PI3K pathway mutant ER+HER2− and TNBC. In the intention-to-treat ER+ cohort, the overall response rate was 30% and the clinical benefit rate was 36%. A decline in PI3K pathway mutant circulating tumor DNA (ctDNA) levels from baseline to week 8 while on therapy was significantly associated with a partial response, clinical benefit, and improved progression-free-survival [HR 0.24; 95% confide..
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Awarded by Amgen
Funding Acknowledgements
The authors thank the following: Novartis for supplying alpelisib; the Molecular Genomics Core and Pathology Department at the Peter MacCallum Cancer Centre for their assistance; and Dr. Madawa Jayawardana for advice on statistical analysis. The authors also acknowledge the generous support of Jeff Eisman. Financial support (grants with source details for each author) is as follows: P. Savas: fellowship support from Cancer Council Victoria; L.L. Lo: PhD scholarship from the National Health and Medical Research Council, the Royal Australasian College of Physicians, and the National Breast Cancer Foundation; S.J. Luen: fellowship support from the Peter MacCallum Cancer Centre; R.J. Hicks: Australian National Health and Medical Research Council Practitioner Fellowship; S.-J. Dawson: CSL Centenary Fellowship and National Health and Medical Research Council Investigator grant (#1196755); and S. Loi: National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York.