Candel Therapeutics Launches Phase 3 Trial for NSCLC Treatment After ICI Failure — Candel Therapeutics, Inc.

Event summary

Candel Therapeutics initiated the global Phase 3 AURORA trial for aglatimagene besadenovec (CAN-2409) in advanced non-small cell lung cancer (NSCLC) patients who failed immune checkpoint inhibitors.
The trial will enroll patients across over 150 sites worldwide, with a primary endpoint of overall survival.
Aglatimagene plus valacyclovir will be tested against standard-of-care docetaxel chemotherapy in combination with continued pembrolizumab.
Phase 2 results showed 50% of patients surviving beyond 24 months despite prior inadequate response to immune checkpoint inhibitors.

The big picture

Candel Therapeutics' Phase 3 AURORA trial addresses a critical unmet need in NSCLC treatment, where approximately 60% of patients experience disease progression within one year of immune checkpoint inhibitor therapy. The trial's success could position aglatimagene besadenovec as a first-in-class immunotherapy, potentially altering the standard of care for this patient population.

What we're watching

Trial Execution: The pace at which Candel Therapeutics can enroll patients across 150 global sites will determine the trial's timeline and potential for success.
Regulatory Pathway: Whether the FDA's Fast Track Designation will expedite approval if Phase 3 results are positive.
Competitive Landscape: How aglatimagene besadenovec differentiates itself in a crowded NSCLC treatment market, particularly for patients who fail immune checkpoint inhibitors.