Celcuity has reported topline outcomes from the PIK3CA mutant cohort of the Phase III VIKTORIA-1 clinical trial assessing gedatolisib combined with fulvestrant, with or without palbociclib, in patients with breast cancer.
The randomised, open-label trial included individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA mutant, locally advanced or metastatic breast cancer (ABC).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
These patients had experienced disease progression after prior treatment with a Cyclin-Dependent Kinases 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.
The primary efficacy analysis showed that the combination of gedatolisib, fulvestrant, and palbociclib, known as the gedatolisib triplet, led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
This benefit was observed compared to the combination of alpelisib and fulvestrant.
A secondary endpoint comparing gedatolisib plus fulvestrant, the gedatolisib doublet, against alpelisib and fulvestrant demonstrated similar benefits, even though it was not part of the hierarchical primary efficacy assessment.
Both treatment regimens featuring gedatolisib were generally well tolerated and exhibited manageable safety profiles, with no new safety signals identified.
Celcuity plans to submit these data to the US Food and Drug Administration (FDA) as a supplemental new drug application (NDA), with further submissions to other regulatory authorities set to follow.
The company stated that HR+/HER2- breast cancer constitutes around 70% of all breast cancer cases, with about 40% displaying PIK3CA mutations.
Celcuity chief medical officer Igor Gorbatchevsky said: “These positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with PIK3CA mutant HR+/HER2- advanced breast cancer.”
“When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient’s tumour.”
The FDA has granted priority review of the company’s new drug application (NDA) for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, with a decision expected by 17 July 2026.
The Phase III VIKTORIA-1 clinical trial is fully enrolled and assessed participants based on PIK3CA mutation status, with separate results previously reported for the wild-type subgroup.
In February 2024, Celcuity dosed the first subject in the Phase Ib/II CELC-G-201 clinical trial of gedatolisib plus Nubeqa (darolutamide) to treat metastatic castration-resistant prostate cancer (mCRPC).
