Celcuity Inc. announced positive overall survival (OS) data from a Phase 1b trial of gedatolisib in combination with palbociclib and endocrine therapy for patients with HR+, HER2- advanced or metastatic breast cancer. The results were presented at the San Antonio Breast Cancer Symposium on December 11, 2024.
For the treatment-naïve patient cohort (N=41), the median OS was 77.3 months, demonstrating a substantial survival benefit. In patients previously treated with a CDK4/6 inhibitor (N=27) who received the Phase 3 dose of gedatolisib, the median OS was 33.9 months.
These OS results compare favorably to published data for currently available first- or second-line standard-of-care regimens for this patient population. The data supports the clinical development strategy of simultaneously blocking the ER, CDK4/6, and PAM signaling pathways, which is being evaluated in the ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 trials.
The company also noted that few patients, less than 10%, discontinued treatment due to an adverse event, indicating a manageable safety profile for the combination therapy.
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