Celcuity reports updated gedatolisib combo results in early-stage breast cancer study

• Celcuity (NASDAQ:CELC +3.3%) announces updated results from a four-arm Phase 1b expansion study at presented a poster at the 2021 San Antonio Breast Cancer Symposium.
• The study evaluated gedatolisib in combination with palbociclib, a CDK4/6 inhibitor and endocrine therapy (either letrozole or fulvestrant) in women with ER+/HER2- advanced breast cancer (ABC).
• Consistent with the previously released results, the addition of gedatolisib to palbociclib and endocrine therapy demonstrated promising antitumor activity in both first and later line settings for ER+/HER2- ABC that compared favorably to historical controls.
• A significant objective response rate (ORR) was also observed in patients refractory to their last treatment or who had received two or more lines of prior treatment for advanced breast cancer.
• Arm A (n=31): Patients who were treatment naive in the ABC setting (1^st line): ORR: 85%; PFS: 31.1 months.
• Arm B (n=13): Patients who received prior endocrine therapy without a CDK4/6 inhibitor (2^nd line): ORR: 77%; PFS: 11.9 months.
• Arm C (n=32): Patients who received prior treatment with a CDK4/6 inhibitor (2^nd/3^rd line): ORR: 32%; PFS: 5.1 months.
• The ORR in Arm D relative to Arm C was superior irrespective of the number of prior therapies for ABC. Patients who had received 2 or more prior lines of therapy were 2.4 times more likely to report an objective response in Arm D than Arm C (78% vs. 32%).
• Gedatolisib was well tolerated with manageable toxicity and a low number of patients discontinued treatment due to an adverse event.