Celcuity Expands VIKTORIA-2 Trial to 1,180 Patients and Files Subcutaneous Patent
Celcuity expanded its Phase 3 VIKTORIA-2 trial to include 440 endocrine-resistant and 740 endocrine-sensitive HR+/HER2- advanced breast cancer patients, each randomized to gedatolisib plus palbociclib and endocrine therapy versus ribociclib combinations with independent PFS endpoints. It filed a patent for a subcutaneous gedatolisib formulation to support long-term use.
1. VIKTORIA-2 Trial Expansion
Celcuity amended its VIKTORIA-2 Phase 3 protocol to enroll 440 endocrine-resistant and 740 endocrine-sensitive HR+/HER2- ABC patients, assigning them to gedatolisib plus palbociclib and endocrine therapy or ribociclib combinations. Each study will independently assess PFS per RECIST 1.1 with separate statistical plans and blinded central review.
2. Subcutaneous Gedatolisib Patent Application
The company submitted its first patent application for a subcutaneous gedatolisib formulation to enable injection over infusion and is developing clinical equivalence to the intravenous form. This formulation aims to improve patient convenience and support treatment durations extending beyond several years.
3. Phase 1b Results and Market Potential
In a Phase 1b trial of endocrine-sensitive HR+/HER2- ABC, gedatolisib combined with palbociclib and letrozole yielded a median PFS of 48.6 months, median overall survival of 77.3 months and a 79% objective response rate. Celcuity expects this triplet to potentially redefine first-line standard of care for approximately 90,000 annual late-stage patients.