Celcuity Presents Updated Results from the PIK3CA MT Cohort of the Phase 3 VIKTORIA-1 Study in Patients with HR+/HER2- Advanced Breast Cancer at the ESMO Congress 2026
Celcuity presented updated Phase 3 VIKTORIA-1 subgroup data at ESMO 2026 showing the gedatolisib triplet delivered 21.5 months median PFS versus 9.1 months for alpelisib plus fulvestrant in PIK3CA-mutant HR+/HER2- breast cancer patients without liver metastases. The triplet also posted a 59% ORR with 19.4 months median duration of response versus 33% and 7.5 months for the alpelisib control, and TEAE discontinuation rates were far lower (5% vs 19% for alpelisib).
Key figures
- Drug Name
- gedatolisib (REVTORPYK)
- Phase Of Trial
- Phase 3
- Orr control percent
- 33
- Orr doublet percent
- 43
- Orr triplet percent
- 59
- Pfs control no liver mets months
- 9.1
- Pfs doublet no liver mets months
- 11.5
- Pfs triplet no liver mets months
- 21.5
- Teae discontinuation doublet percent
- 4
- Teae discontinuation triplet percent
- 5
- Teae discontinuation alpelisib percent
- 19
- Median duration of response triplet months
- 19.4
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.