# gedatolisib 三重療法在無進展存活期上相較於 alpelisib 加 fulvestrant 顯示出統計學上顯著的改善。

*biotech · news · 2026-06-02 · Benzinga*

## Key points

- gedatolisib 三重療法的中位無進展存活期是 alpelisib 加 fulvestrant 的兩倍（11.1 個月對 5.6 個月）。
- VIKTORIA-1 試驗是首個顯示一種 PI3K/AKT/mTOR 抑制劑優於另一種的第三期臨床試驗。
- gedatolisib 三重療法在第二線內分泌治療基礎的第三期試驗中達成最高的客觀反應率。
- Celcuity 計劃提交 VIKTORIA-1 數據以申請 FDA 核准，並推動國際監管申請。

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. Photo by Aunt Spray via Shutterstock

**Companies:** Celcuity
**Countries:** United States

[Read the full story on Benzinga](https://www.benzinga.com/trading-ideas/movers/26/06/52950316/whats-going-on-with-celcuity-stock-on-tuesday)

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