Celcuity trial results presented on October 24, 2026, showed longer median progression-free survival with gedatolisib-based combinations than with alpelisib plus fulvestrant across several advanced breast cancer subgroups. The Phase 3 VIKTORIA-1 update focused on patients with PIK3CA-mutated tumors, with the largest reported median for the three-drug regimen in patients without liver metastases.
Key Takeaways
- Patients without liver metastases had median progression-free survival of 21.5 months on the gedatolisib triplet, versus 9.1 months on the control regimen.
- Response rates and median response duration favored both gedatolisib combinations, although not every subgroup survival comparison was statistically significant.
- Adverse-event-related discontinuation of gedatolisib was 5% with the triplet and 4% with the doublet, compared with 19% for alpelisib.
Table of Contents
- Celcuity trial results distinguish two treatment combinations
- Survival findings vary by metastatic disease subgroup
- Tumor responses and treatment discontinuations
- Conclusion
Celcuity trial results distinguish two treatment combinations
Celcuity’s VIKTORIA-1 trial design evaluates gedatolisib plus fulvestrant, with or without palbociclib, as second-line treatment for HR+/HER2- advanced breast cancer previously treated with a CDK4/6 therapy and an aromatase inhibitor. The three-drug combination is described as the triplet; gedatolisib plus fulvestrant is the doublet.
Dr. Barbara Pistilli, head of the Breast Cancer Unit at Gustave Roussy, presented the updated PIK3CA-mutant cohort analyses at the European Society for Medical Oncology Congress 2026. The control treatment for this cohort was alpelisib plus fulvestrant.
The mutation distinction matters for Celcuity’s development program. The company said gedatolisib, marketed as REVTORPYK, already has FDA approval for patients without a detected PIK3CA mutation following progression on or after at least one line of endocrine therapy in the metastatic setting. This presentation concerned the separate mutation-positive cohort, not an announcement of a new approval.
| Item | Details |
|---|---|
| Gedatolisib triplet | PIK3CA-mutant evaluable-disease population: 133 patients; objective response rate 59%; median response duration 19.4 months. |
| Gedatolisib doublet | PIK3CA-mutant evaluable-disease population: 42 patients; objective response rate 43%; median response duration 27.8 months. |
| Alpelisib plus fulvestrant | PIK3CA-mutant evaluable-disease population: 127 patients; objective response rate 33%; median response duration 7.5 months. |
Survival findings vary by metastatic disease subgroup
Among patients without liver metastases, median progression-free survival was 21.5 months with the triplet, 11.5 months with the doublet and 9.1 months with the control. Progression-free survival measures time before disease progression or death; it is not a measure of overall survival.
The triplet comparison in this subgroup had a hazard ratio of 0.46 and a p-value of 0.0016. The doublet comparison had a hazard ratio of 0.71 and a p-value of 0.1627, so its numerically longer median did not establish a statistically significant benefit in that subgroup.
For patients with liver metastases, median progression-free survival was 9.1 months with the triplet and 11.1 months with the doublet, versus 4.6 months with the control. In patients with visceral metastases, the corresponding medians were 9.8, 11.3 and 5.6 months.
These are subgroup findings rather than interchangeable estimates for every patient in the trial. The doublet subgroups were also smaller: 28 patients without liver metastases and 24 with liver metastases, compared with 77 and 78, respectively, in the triplet groups.
Tumor responses and treatment discontinuations
In patients with evaluable disease in the PIK3CA-mutant cohort, both gedatolisib regimens produced higher objective response rates and longer median response durations than the control. Response rates included confirmed and unconfirmed responses.
The safety update measured discontinuation of gedatolisib or alpelisib because of treatment-emergent adverse events, rather than discontinuation of every component of each combination. Celcuity also reported that grade 3 stomatitis events improved within one to two weeks. Discontinuation because of stomatitis was 1% with the triplet and 0% with the doublet.
Celcuity cautioned that efficacy and safety analyses remain ongoing and that results may change after a more comprehensive review.
Conclusion
The update adds subgroup and response data to Celcuity’s mutation-positive breast cancer program without announcing a new regulatory decision. Beyond continued VIKTORIA-1 analysis, the company’s ongoing Phase 3 VIKTORIA-2 trial is evaluating gedatolisib combinations in first-line advanced breast cancer; no new results date was provided.
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