Gedatolisib combinations double PFS vs alpelisib in PIK3CA-mutant advanced breast cancer

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Published: 2 Jun 2026
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Dr Sara Hurvitz - Fred Hutchinson Cancer Center, Seattle, USA

Dr Hurvitz talks to ecancer at ASCO 2026 about data she presented form the phase 3 VIKTORIA-1 study.

This found that investigational pan-PI3K/mTOR inhibitor gedatolisib, combined with fulvestrant with or without palbociclib, significantly improved progression-free survival (PFS) compared with standard alpelisib plus fulvestrant in patients with HR-positive, HER2-negative, PIK3CA-mutant advanced breast cancer previously treated with CDK4/6 inhibitors and aromatase inhibitors.

At a median follow-up of 11 months, median PFS reached 11.1 months with the gedatolisib triplet and 11.3 months with the doublet, versus 5.6 months with alpelisib/fulvestrant, representing a ~50% reduction in risk of progression.

Dr Hurvitz notes that these findings could suggets gedatolisib-based combinations as a new second-line standard of care in this patient population, regardless of PIK3CA mutation status.

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