Interim Data Show Promising Results for Intermittent Gedatolisib Dose in PIK3CA-Mutant Breast Cancer
Celcuity (NASDAQ: CELC) provided an update today: the PIK3CA mutant cohort in its Phase 3 VIKTORIA-1 trial is now fully enrolled, marking a significant milestone in developing targeted therapies for advanced breast cancer. Fresh results from an accompanying Phase 1b trial show median progression-free survival (PFS) of 19.7 months for PIK3CA-mutated patients who received the same intermittent gedatolisib regimen under evaluation in the pivotal study.
PIK3CA Mutant Cohort Fully Enrolled: Pivotal Data Expected in 2026
According to Celcuity CEO Brian Sullivan, the VIKTORIA-1 PIK3CA mutant cohort’s full enrollment puts the company on track to deliver topline results by late Q1 or Q2 2026. This cohort includes patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutant tumors—an area where new targeted therapies are urgently needed following progression on CDK4/6 and aromatase inhibitors.
Phase 1b Data Underscore Efficacy of Intermittent Dose
Updated efficacy analysis from the Phase 1b study highlighted several key points:
- Median PFS reached 14.6 months across all PIK3CA-mutated patients (n=30).
- Patients receiving the intermittent gedatolisib dose—the same dosing as in VIKTORIA-1—saw a median PFS of 19.7 months (n=11), and an objective response rate (ORR) of 64%.
- For context, PIK3CA wild-type patients saw a median PFS of 9.0 months overall, and 9.1 months for the intermittent dosing subgroup, with ORRs of 41% and 53%, respectively.
The table below summarizes these results for ease of comparison:
| Group | N | Median PFS (months) | ORR |
|---|---|---|---|
| PIK3CA MT - All | 30 | 14.6 | 48% |
| PIK3CA MT - Intermittent Dose | 11 | 19.7 | 64% |
| PIK3CA WT - All | 60 | 9.0 | 41% |
| PIK3CA WT - Intermittent Dose | 15 | 9.1 | 53% |
Clinical Relevance and Looking Ahead
The data suggest a notable benefit for the intermittent dosing schedule in PIK3CA-mutated, HR+/HER2- advanced breast cancer, an insight that could shape future treatment protocols if confirmed in Phase 3. Celcuity’s differentiated approach targets the PAM pathway via gedatolisib—a mechanism distinct from existing PI3K, AKT, or mTORC1 inhibitors.
Takeaway: Why These Results Matter
While sample sizes are still modest and these are interim analyses, the prolonged PFS and encouraging ORR for the intermittent regimen stand out. For investors and clinicians alike, attention now shifts to the pending topline results in 2026. If these trends persist, gedatolisib could play a central role in redefining care for a high-need subset of advanced breast cancer patients.
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