Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer
Celcuity reported positive Phase 3 results from the PIK3CA mutant cohort of the VIKTORIA-1 trial, showing gedatolisib regimens doubled the likelihood of survival without disease progression compared to alpelisib plus fulvestrant. The gedatolisib-triplet achieved a hazard ratio of 0.50 (p<0.0001) with a median PFS of 11.1 months versus 5.6 months for the control, while the gedatolisib-doublet showed a hazard ratio of 0.51 with a median PFS of 11.3 months.
Key figures
- Drug Name
- gedatolisib
- Phase Of Trial
- Phase 3
- Orr doublet
- 35.7%
- Orr triplet
- 48.9%
- P value doublet
- 0.0013
- P value triplet
- <0.0001
- Enrollment mt cohort
- 350
- Hazard ratio doublet
- 0.51
- Hazard ratio triplet
- 0.5
- Median dor doublet months
- 24.2
- Median dor triplet months
- 15.7
- Median pfs control months
- 5.6
- Median pfs doublet months
- 11.3
- Median pfs triplet months
- 11.1
AI analysis
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