Artigo
CancerVIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER22/ PIK3CA Wild-Type Advanced Breast Cancer
Autor(es): Sara A. Hurvitz, MD 1 ; Rachel M. Layman, MD 2; Giuseppe Curigliano, MD, PhD 3,4; Fabrice Andr´ e,MD, PhD 5; Massimo Cristofanilli, MD 6;Sung-Bae Kim, MD, PhD 7; Jorge Luis Mart´ınez Rodr´ıguez, MD 8; Jorge C. Nadal, MD 9; Gun Min Kim, MD 10; Louisa Lo, MD, PhD 11 ; Yuly A. Remolina-Bonilla, MD 12; Geronimo Rosselli, MD 13; George Emile, MD 14; Ernesto Korbenfeld, MD 15 ; Juan Manuel Puig, MD 16 ; Robert Wesolowski, MD 17; Miguel Martin, MD, PhD 18; Alistair Ring, MD 19; Hyo S. Han, MD 20 ; Antonio Giordano, MD, PhD 21; Sarah C. Mutka, PhD 22; Keren Moss, MD 22; Sam Suzuki, MS 22; Brian Sullivan, AB 22 ; Igor Gorbatchevsky, MD 22 ; and Barbara Pistilli, MD 5, for the VIKTORIA-1 Study Group
ABSTRACT
PURPOSE
Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K/AKT/mTOR pathway and has shown compelling activity in early clinical trials with palbociclib and fulvestrant.
METHODS
This phase III randomized trial (VIKTORIA-1; ClinicalTrials.gov identifier: NCT05501886) evaluated the efficacy of gedatolisib-based therapy, comparing gedatolisib, palbociclib, and fulvestrant (gedatolisib triplet) and gedatolisib plus fulvestrant (gedatolisib doublet) with fulvestrant monotherapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2– negative (HER22), PIK3CA wild-type (WT) advanced breast cancer. Eligible patients had disease progression during or after CDK4/6 inhibitor and aromatase inhibitor treatment. Comparison of progression-free survival as assessed by blinded independent central review for gedatolisib triplet versus fulvestrant and gedatolisib doublet versus fulvestrant was the primary objective.
RESULTS
A total of 392 patients were randomly assigned 1:1:1. The median study follow-up was 10.1 months. The median progression-free survival was 9.3 months in the gedatolisib-triplet group, 2.0 months in the fulvestrant group (hazard ratio [HR] for progression or death, 0.24 [95% CI, 0.17 to 0.35]; P < .001), and 7.4 months in the gedatolisib-doublet group (HR, 0.33 [95% CI, 0.24 to 0.48]; P < .001 v fulvestrant). Grade ≥3 treatment-related adverse events (TRAEs) reported in the gedatolisib-triplet and gedatolisib-doublet groups, respectively, included neutropenia (62.3%, 0.8%), stomatitis (19.2%, 12.3%), rash (4.6%, 5.4%), hyperglycemia (2.3%, 2.3%), and diarrhea (1.5%, 0.8%). Study treatment discontinuation because of TRAEs was reported in 2.3% (triplet) and 3.1% (doublet) of patients.
CONCLUSION
The addition of gedatolisib to fulvestrant, with or without palbociclib, significantly reduced the risk of disease progression or death in patients with hormone receptor–positive/HER22, PIK3CA WT advanced breast cancer.
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