Celcuity Expands Gedatolisib Phase 3 Program in First-Line Breast Cancer Setting

MT Newswires Live05-14

Celcuity (CELC) has expanded its phase 3 VIKTORIA-2 trial of gedatolisib in first-line hormone receptor-positive, HER2-negative advanced breast cancer to include a separate cohort of endocrine-sensitive patients, the company said Thursday.

The updated trial will evaluate endocrine-resistant and endocrine-sensitive patients in two parallel arms, with assignment based on endocrine sensitivity status before randomization, the company said.

The company said the changes follow positive prior study data and discussions with the US Food and Drug Administration, and aim to expand evaluation of gedatolisib in a broader first-line patient population.

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