Preliminary data announced for gedatolisib from Ph 1 CELC-G-201 trial in metastatic CRPC and Ph 2 HER2+ metastatic breast cancer patients
“We are very encouraged by this preliminary efficacy and safety data,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib. Available gedatolisib pharmacokinetic (PK) data from other clinical trials in solid tumors suggests a relationship between efficacy and dose levels. Since this preliminary data indicates that the optimal gedatolisib dose for patients with mCRPC may not yet have been reached, the company amended the clinical trial protocol to enable exploration of additional doses in the Phase 1/1b portion of this clinical trial to determine the recommended Phase 2 dose.”
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