Briacell phase 3 enrolment on track for H1 2026 readout

Executive Summary

• Briacell Therapeutics reports that its pivotal Phase 3 clinical study for Bria-IMT in metastatic breast cancer (MBC) is on track, having screened over 230 patients and enrolled over 160 patients to date.
• The company anticipates reporting top-line interim data in the first half of 2026 (H1 2026), contingent upon the occurrence of 144 patient events (deaths).
• The Phase 3 combination regimen (Bria-IMT plus an immune checkpoint inhibitor) retains FDA fast-track designation, with positive results potentially supporting full approval and marketing authorization.

Key Details

• Enrollment Status: Over 230 patients screened and over 160 patients enrolled in the pivotal Phase 3 study.
• Data Readout Timeline: Top-line interim data expected in H1 2026.
• Analysis Trigger: Interim data will be analyzed once 144 patient events (deaths) occur.
• Primary Endpoint: Overall survival (OS).
• Study Design: Evaluating Bria-IMT plus an immune checkpoint inhibitor versus physician's choice therapy in advanced metastatic breast cancer.
• Regulatory Status: The regimen continues under FDA fast-track designation.
• Strategic Importance: Positive results could support full approval and marketing authorization of Bria-IMT for MBC patients.

Notable Quotes

• "The pace of patient enrollment in our pivotal phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators," stated Dr. William V. Williams, Briacell's president and chief executive officer.