Candel Therapeutics Initiates Global Phase 3 Trial for CAN-2409 in NSCLC
Candel Therapeutics announced the initiation of its global pivotal Phase 3 AURORA trial for aglatimagene besadenovec (CAN-2409) in combination with valacyclovir and continued pembrolizumab. This trial targets patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed despite prior immune checkpoint inhibitor and platinum-based chemotherapy. The study, which has its first site open for enrollment, will compare this regimen against standard-of-care docetaxel chemotherapy, with overall survival as the primary endpoint. The FDA previously granted Fast Track Designation to aglatimagene for NSCLC, and Candel has partnered with Parexel International for trial execution.
Key Highlights
- Candel initiated global pivotal Phase 3 AURORA trial for aglatimagene besadenovec (CAN-2409).
- Trial evaluates CAN-2409 + valacyclovir + pembrolizumab vs. docetaxel in metastatic NSCLC.
- Targets patients with progressive disease after prior pembrolizumab and platinum chemotherapy.
- The global trial is expected to enroll patients across approximately 150 sites worldwide.
- Primary endpoint is overall survival; first site is now open for enrollment.
- FDA previously granted Fast Track Designation to aglatimagene for NSCLC.
- Candel engaged Parexel International to support global execution of the trial.
- Phase 2 trial showed median overall survival of 25.4 months in the target patient population.
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