Celcuity announces positive topline Phase 3 data from a clinical trial evaluating the investigational drug gedatolisib in breast cancer.
VIKTORIA-1
A Phase 3 trial evaluating gedatolisib as a 1st-line treatment for HR+/HER2- advanced breast cancer
Celcuity is a clinical-stage biotechnology company focused on developing a better way to address cellular abnormalities that drive tumor growth. More specifically, our teams of drug development scientists, biochemists, and molecular biologists are working to advance new targeted therapies for cancers involving the PAM (PI3K/AKT/mTOR) pathway. This pathway is central to a range of cancers, including breast, prostate, lung, endometrial, colon, and ovary, among others.
Our lead product candidate, gedatolisib, is a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, and/or mTORC1 alone or together. Gedatolisib thus offers hope to meaningfully extend the time patients are responding to their cancer treatment.
Rationale
Simultaneous inhibition of the PAM (PI3K/AKT/mTOR) pathway with gedatolisib, the CDK4/6 pathway with palbociclib, and the estrogen receptor pathway with fulvestrant, is intended to disrupt complex cooperation between these pathways to inhibit tumor growth.
Available evidence indicates that resistance to CDK4/6 inhibition is a transient adaptive mechanism, most likely involving the PAM pathway. Continuing CDK4/6 inhibition in combination with PAM inhibition in patients who progressed on their prior CDK4/6 inhibitor is expected to both block the reactivated CDK4/6 pathway and prevent adaptive activation of the PAM pathway.
Patients whose disease progressed on a CDK4/6 inhibitor may thus potentially benefit from continued treatment with a CDK4/6 and ER inhibitor when it is combined with a PAM inhibitor as their next line of therapy.
Key eligibility criteria
- Locally advanced or metastatic ER+, HER2- breast cancer
- Confirmed PIK3CA mutation status
- Prior treatment with a CDK4/6 inhibitor combined with an aromatase inhibitor
- No prior treatment with AKT, PI3K, mTOR inhibitors
- No prior chemotherapy for advanced disease
- No more than 2 prior lines of endocrine therapy treatment for metastatic disease
Key endpoints
- Arm A vs. Arm C
- Arm B vs. Arm C
- Arm D vs. Arm E
- Overall survival
- Overall response rate
- Duration of response
Study locations
VIKTORIA-1 is being conducted at sites in North America, Europe, South America, Australia, and Asia.