New Hope for Treatment-Naïve Breast Cancer Patients: Celcuity Reveals Promising Results from Phase 1b Study of Gedatolisib at ESMO Breast Cancer Conference

Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, has announced the impressive results from their Phase 1b trial of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor, and letrozole, an aromatase inhibitor, at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany. This promising combination of treatments has the potential to revolutionize the treatment of oncology and may provide an effective alternative to existing therapies.

At the San Antonio Breast Cancer Symposium last December, efficacy and safety data for treatment-naïve patients with HR+, HER2- advanced breast cancer enrolled in Escalation Arm A and Expansion Arm A was presented.

The median progression-free survival (mPFS) for treatment-naïve patients in Escalation Arm A (n=11) and Expansion Arm A (n=30) was 45.8 months and 48.6 months respectively, and 48.6 months when both arms were combined (n=41). Moreover, the median duration of response (mDOR) was 46.9 months. Notably, median PFS in Expansion Arm A had not yet been reached when this data was reported.

The results of the median PFS and DOR for gedatolisib in combination with letrozole and palbociclib are truly impressive and have demonstrated superiority when compared to current standard-of-care treatments for HR+, HER2- advanced breast cancer patients. This exciting data warrants further exploration of gedatolisib with a CDK4/6 inhibitor and endocrine therapy in earlier settings, such as first-line, neoadjuvant, or adjuvant indications. According to Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity, these positive results are reason for great optimism.

Phase 1b Study Design and Results for Treatment-Naïve Patients

Gedatolisib, in combination with palbociclib and an endocrine therapy, was trialled in a Phase 1b clinical trial on 138 patients with HR+, HER2- advanced breast cancer. Updated efficacy and safety data from treatment naïve patients from the two dose escalation and four dose expansion arms were presented at the ESMO Breast Cancer Congress, showcasing promising results.

About Gedatolisib

Gedatolisib is a revolutionary, pan-PI3K and mTOR inhibitor with remarkable potency for all four Class I PI3K isoforms and mTORC1 and mTORC2. Unlike other therapies that target PI3K or mTOR individually, this inhibitor has the potential to prevent drug resistance by targeting all four isoforms and mTOR.

In a Phase 1b clinical trial, gedatolisib in combination with palbociclib and endocrine therapy demonstrated promising results with a robust response rate and a manageable side effect profile in patients with HR+/HER2- advanced breast cancer. Now, the Phase 3 clinical trial, VIKTORIA-1, is enrolling patients to further evaluate gedatolisib in combination with fulvestrant with or without palbociclib in the same patient population.

About Celcuity

Celcuity is revolutionizing the way we treat solid tumors with its targeted therapies. Its lead therapeutic candidate, gedatolisib, is an innovative medication that works on the PI3K and mTOR pathways to offer better results than therapies that target either pathway alone.

Currently, Celcuity is enrolling patients for a Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib with fulvestrant and/or palbociclib in HR+/HER2- advanced breast cancer patients. With this groundbreaking approach, Celcuity is transforming cancer care and providing hope for a brighter future.

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