T4K3.news

Celcuity completes successful breast cancer trial

Celcuity's phase 3 trial results set the stage for an FDA filing this fourth quarter.

July 28, 2025 at 10:00 AM

Celcuity's breast cancer combo hits goals, teeing up FDA filing

Celcuity's latest breast cancer trial results pave the way for FDA approval.

Celcuity breast cancer combination achieves major trial success

Celcuity's phase 3 clinical trial for its breast cancer treatment has surpassed primary goals, setting the stage for an FDA filing later this year. The trial focused on combinations of gedatolisib, a PI3K and mTOR inhibitor, with other existing drugs. In the trial, the triplet combination reduced the risk of disease progression or death by 76% compared to fulvestrant alone, while the doublet achieved a 67% reduction. Both combinations showed significantly better progression-free survival periods than the control group. Celcuity's CEO expressed optimism about these results, expecting them to impact treatment paradigms for HR-positive, HER2-negative breast cancer.

Key Takeaways

✔️

Celcuity's trial hit primary endpoints ahead of FDA filing.

✔️

Triplet combination reduced disease progression risk by 76%.

✔️

Doublet combination showed a 67% reduction in risk.

✔️

Progression-free survival was significantly longer than controls.

✔️

CEO emphasized the importance of the hazard ratio in treatment success.

✔️

Anticipation builds for upcoming data sharing and FDA filing.

"The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing."

Dr. Sara Hurvitz emphasizes the significance of the trial results.

"A hazard ratio of 0.5 or below would be considered very compelling."

Brian Sullivan describes the importance of the trial's hazard ratio in assessing treatment efficacy.

"The triplet reduced the risk of disease progression or death by 76%."

This statistic highlights the effectiveness of the triplet treatment.

"The rate of discontinuation because of treatment-related adverse events was lower in the doublet and triplet cohorts."

Celcuity reports better tolerability compared to other treatments, suggesting improved patient experience.

The encouraging results from Celcuity's trial signify a remarkable advancement in breast cancer treatment, particularly for a hard-to-treat patient population. The strong efficacy demonstrated may redefine current therapeutic approaches. With the backdrop of the ongoing competitive landscape, Celcuity's findings could resonate deeply within the medical community. As healthcare professionals look for effective treatment options, this development could influence prescribing practices and patient outcomes. Anticipation for the FDA filing adds another layer of excitement and uncertainty in the market.

Highlights

This could be a game changer for breast cancer treatment.
The data might redefine survival expectations for patients.
Celcuity sets the bar higher for cancer therapies.
A significant milestone for advanced breast cancer care.

Potential risks related to FDA approval process

The pathway to FDA approval carries inherent risks, including possible rejection or delays, impacting investors and the future of the treatment. Stakeholders are watching closely for public reactions to these trial outcomes.

Celcuity's promising data sets a new benchmark for advanced breast cancer treatments.

🏷️

celcuity breast cancer clinical trials cancer treatment fda filing health biotechnology pharmaceuticals

Enjoyed this? Let your friends know!