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VIKTORIA-1

Needs review

VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer

Phase 3N = 392NCT05501886

Population
HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer with progression during or after CDK4/6 inhibitor and aromatase inhibitor treatment (the PIK3CA wild-type cohort, 392 patients)
Design
Randomized phase III trial (1:1:1) of gedatolisib plus palbociclib plus fulvestrant (triplet), gedatolisib plus fulvestrant (doublet), or fulvestrant alone; primary objective PFS by blinded independent central review for each gedatolisib arm versus fulvestrant
Primary endpoint
PFS
Arms
  • Gedatolisib triplet (experimental): Gedatolisib plus palbociclib plus fulvestrant
  • Gedatolisib doublet (experimental): Gedatolisib plus fulvestrant
  • Fulvestrant (control): Fulvestrant monotherapy
People
Hurvitz SA, VIKTORIA-1 Study Group
PFSHR 0.24 (95% CI 0.17–0.35)Δ median PFS+7.3 monthsPFSHR 0.33 (95% CI 0.24–0.48)Δ median PFS+5.4 months
Show the numbers
Results reported for VIKTORIA-1
EndpointAnalysisGedatolisib triplet / Gedatolisib doubletFulvestrantEffect
PFSprimarymedian follow-up 10.1 monthsHurvitz 2026median 9.3 monthsmedian 2 monthsHR 0.24 (95% CI 0.17–0.35)P<.001Blinded independent central review. Short median follow-up (10.1 months).
PFSprimarymedian follow-up 10.1 monthsHurvitz 2026median 7.4 monthsmedian 2 monthsHR 0.33 (95% CI 0.24–0.48)P<.001Blinded independent central review.
Results reported for VIKTORIA-1
EndpointAnalysisGedatolisib triplet / Gedatolisib doubletFulvestrantEffect
PFSprimarymedian follow-up 10.1 monthsHurvitz 2026median 9.3 monthsmedian 2 monthsHR 0.24 (95% CI 0.17–0.35)P<.001Blinded independent central review. Short median follow-up (10.1 months).
PFSprimarymedian follow-up 10.1 monthsHurvitz 2026median 7.4 monthsmedian 2 monthsHR 0.33 (95% CI 0.24–0.48)P<.001Blinded independent central review.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.240.17–0.35
PFS0.330.24–0.48
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Gedatolisib triplet (experimental)
  • Fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsGedatolisib tripletFulvestrant
0100.0%100.0%
663.9%12.5%
1240.9%1.6%
1728.2%0.3%
2318.0%0.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Gedatolisib doublet (experimental)
  • Fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsGedatolisib doubletFulvestrant
0100.0%100.0%
562.6%17.7%
943.0%4.4%
1426.9%0.8%
1916.9%0.1%
Primary publication: Hurvitz SA, Layman RM, Curigliano G, André F, Cristofanilli M, Kim SB, et al. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026;44(12):1108-1119. PubMedDOI

Appears in

Sources

  1. Hurvitz SA, Layman RM, Curigliano G, André F, Cristofanilli M, Kim SB, et al. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026;44(12):1108-1119.

    PubMedDOI