Celcuity Inc. (NASDAQ: CELC) experienced a remarkable surge of over 100% in pre-market trading following the groundbreaking results of its Phase 3 VIKTORIA-1 trial for gedatolisib, a targeted therapy for advanced breast cancer. The trial focused on women with hormone receptor-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, a challenging form of the disease to treat. By combining gedatolisib with existing drugs fulvestrant and palbociclib, the study achieved exceptional outcomes that could potentially redefine the standards of care in breast cancer treatment. This significant milestone represents the first time a PI3K/AKT/mTOR pathway inhibitor has demonstrated such promising Phase 3 results in PIK3CA wild-type breast cancer patients, a group that has historically lacked effective targeted therapies. Dr.
Sara Hurvitz, co-principal investigator and SVP at Fred Hutchinson Cancer Center, expressed astonishment at the quadrupling of survival without disease progression, a feat unprecedented in Phase 3 trials. Moreover, gedatolisib exhibited a favorable safety profile, with lower incidences of common toxicities like hyperglycemia and stomatitis, leading to fewer treatment discontinuations due to side effects compared to existing alternatives. Celcuity’s plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2025 signal a significant step towards making this innovative therapy available to patients. Full clinical data from the wild-type patient cohort will be unveiled at an upcoming medical conference, while data from the PIK3CA mutation cohort is anticipated by the year’s end. Unlike conventional targeted therapies that focus on a single component of the PI3K/AKT/mTOR pathway, gedatolisib stands out as a multi-target PAM inhibitor, offering a comprehensive approach to tackling resistant tumors and enhancing treatment efficacy, even in patients typically unresponsive to single-target drugs.
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