Celcuity's Breast Cancer Therapy Shows Promising Results in Late-Stage Trial

Celcuity, a Minneapolis-based biotechnology firm, has announced successful results from a late-stage trial of its experimental breast cancer therapy, gedatolisib. The drug, when used in combination with other treatments, significantly reduced the risk of disease progression or death in patients with advanced hormone receptor-positive (HR+), HER2-negative breast cancer.

Trial Results and Clinical Significance

The Phase 3 trial, known as the VIKTORIA study, tested gedatolisib in two combination regimens:

1. A "doublet" combination of gedatolisib and fulvestrant (AstraZeneca's Faslodex)
2. A "triplet" combination of gedatolisib, fulvestrant, and Pfizer's Ibrance

Both combinations showed remarkable improvements in progression-free survival (PFS) compared to fulvestrant alone:

• The triplet combination reduced the risk of disease progression by 76%, with a median PFS of 9.3 months versus 2 months for fulvestrant alone.
• The doublet combination reduced progression risk by 67%, achieving a median PFS of 7.4 months.

Dr. Sara Hurvitz, co-principal investigator and head of hematology and oncology at the University of Washington's Department of Medicine, described the results as "potentially practice-changing" for patients with HR+, HER2-negative breast cancer that lacks PIK3CA mutations.

Market Impact and Future Plans

The announcement had a significant impact on Celcuity's market position:

• Company shares tripled in early trading before settling at a nearly 200% increase.
• Celcuity's market value rose to approximately $1.5 billion.

Based on these positive results, Celcuity plans to file for FDA approval in the fourth quarter of this year. The company also expects to release data on gedatolisib's efficacy in breast cancer patients with PIK3CA mutations by the end of 2025.

Safety Profile and Comparative Advantage

Importantly, the VIKTORIA study reported lower patient discontinuation rates due to treatment-related adverse events compared to Phase 3 trials of currently approved drug combinations for this patient population. This favorable safety profile, combined with the significant efficacy improvements, positions gedatolisib as a potentially groundbreaking treatment option.

Igor Gorbatchevsky, Celcuity's chief medical officer, emphasized the clinical significance of the results, stating that the "7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm-shifting results."

Industry analysts, including Andrew Berens from Leerink Partners, have noted that the data "are likely clinically meaningful across multiple subgroups" and provide a strong rationale for gedatolisib's use as a second-line breast cancer treatment.

As the pharmaceutical industry awaits full data presentation at an upcoming medical conference, Celcuity's gedatolisib has emerged as a promising candidate in the ongoing effort to improve outcomes for advanced breast cancer patients.