Sergio Cifuentes-Canaval, Medical Oncologist at Las Américas Auna Clinic, shared a post on LinkedIn:
“VIKTORIA-1 Trial: A New Option Emerging for HR+/HER2-, PIK3CA WT Advanced Breast Cancer.
The phase III VIKTORIA-1 trial evaluated gedatolisib, a potent inhibitor targeting all class I PI3K isoforms and both mTORC1 and mTORC2, aiming to comprehensively block the PI3K/AKT/mTOR pathway.
Study design
Patients with HR+/HER2–, PIK3CA wild-type advanced breast cancer progressing after CDK4/6 inhibitor + aromatase inhibitor were randomized to:
- Gedatolisib + palbociclib + fulvestrant
- Gedatolisib + fulvestrant
- Fulvestrant alone
Key results
- Gedatolisib triplet: mPFS 9.3 months
- Gedatolisib doublet: mPFS 7.4 months
- Fulvestrant: mPFS 2.0 months
This translated into substantial risk reductions for progression or death:
- Triplet: HR 0.24
- Doublet: HR 0.33
Safety
The triplet regimen showed expected toxicity from CDK4/6 inhibition, particularly neutropenia (62%), while the doublet had a more favorable hematologic profile. Importantly, treatment discontinuation due to toxicity remained low in both arms.
Why this matters for Latin America
Many patients in LATAM progress after CDK4/6 inhibitors and do not harbor PIK3CA mutations, limiting the use of PI3K inhibitors such as alpelisib.
This creates a therapeutic gap where options often default to chemotherapy.
The VIKTORIA-1 data suggest that PI3K/mTOR pathway targeting may benefit PIK3CA WT patients, potentially expanding targeted therapy options in this setting.
However, several questions remain relevant for our region:
- Access and cost of new targeted agents.
- Optimal sequencing after CDK4/6 inhibitors.
- Integration with existing therapies in resource-constrained health systems.
If confirmed in longer follow-up, gedatolisib-based strategies could represent a meaningful addition for patients with HR+/HER2- PIK3CA WT disease, a population that remains underserved today.
Congrats to Yuly Andrea Remolina Bonilla and all the authors.”
Title: VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER2−/PIK3CA Wild-Type Advanced Breast Cancer
Authors: Sara A. Hurvitz, Rachel M. Layman, Giuseppe Curigliano, Fabrice André, Massimo Cristofanilli, Sung-Bae Kim, Jorge Luis Martínez Rodríguez, Jorge C. Nadal, Gun Min Kim, Louisa Lo, Yuly A. Remolina-Bonilla, Geronimo Rosselli, George Emile, Ernesto Korbenfeld, Juan Manuel Puig, Robert Wesolowski, Miguel Martin, Alistair Ring, Hyo S. Han, Antonio Giordano, Sarah C. Mutka, Keren Moss, Sam Suzuki, Brian Sullivan, Igor Gorbatchevsky, Barbara Pistilli
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