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biotech/news//Benzinga
The gedatolisib-triplet regimen delivered a statistically significant improvement in progression-free survival compared with alpelisib plus fulvestrant.
Gedatolisib-triplet therapy doubled median progression-free survival versus alpelisib plus fulvestrant (11.1 vs 5.6 months).
KEY POINTS
The VIKTORIA-1 trial is the first Phase 3 study showing superiority of one PI3K/AKT/mTOR inhibitor over another.
Gedatolisib-triplet achieved the highest objective response rate reported in second-line endocrine therapy-based Phase 3 trials.
Celcuity plans to submit VIKTORIA-1 data for FDA approval and pursue international regulatory filings.
Gedatolisib Outperformed Comparator Regimen
According to the company, the gedatolisib-triplet regimen delivered a statistically significant improvement in progression-free survival compared with alpelisib plus fulvestrant.
Patients receiving the triplet therapy achieved a median progression-free survival of 11.1 months versus 5.6 months for the comparator arm.
Celcuity said the treatment reduced the risk of disease progression or death by 50%, based on a hazard ratio of 0.50.
The objective response rate reached 48.9%, compared with 26.0% for alpelisib plus fulvestrant.
Median duration of response was 15.7 months for the gedatolisib-triplet versus 7.5 months for the comparator regimen.
The company also reported encouraging results for the gedatolisib-doublet regimen. Median progression-free survival was 11.3 months, more than double the 5.6 months reported for alpelisib plus fulvestrant.
The doublet achieved an objective response rate of 35.7% and a median duration of response of 24.2 months.
Trial Establishes Several Development Milestones
Celcuity said VIKTORIA-1 became the first Phase 3 study to demonstrate superiority of one PI3K/AKT/mTOR pathway inhibitor over another in this patient population.
The company added that the 11.1-month median progression-free survival reported for the gedatolisib-triplet is the highest reported in a Phase 3 study evaluating a second-line endocrine therapy-containing regimen for HR-positive, HER2-negative advanced breast cancer.
It also said the 48.9% objective response rate is the highest reported in a Phase 3 trial of a second-line endocrine therapy-based regimen in this setting.
Celcuity Regulatory Filings Planned
While overall survival data remain immature, Celcuity said both the gedatolisib-triplet and doublet arms showed promising trends on the key secondary endpoint.
The company plans to submit the VIKTORIA-1 data to the U.S. Food and Drug Administration as part of a supplemental New Drug Application and intends to seek approvals from additional regulatory agencies afterward.
CELC Price Action: Celcuity shares were down 25.03% at $92.18 at the time of publication on Tuesday, according to Benzinga Pro data.
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