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Pivotal Phase 3 initiation with OS primary endpoint and extensive site network can unlock meaningful value if readouts are favorable; FDA Fast Track raises probability of expedited development, though ultimate approval hinges on OS data and safety.
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CADL announced the initiation of AURORA, a global pivotal Phase 3 trial of aglatimagene besadenovec with valacyclovir and continued pembrolizumab in metastatic non-squamous NSCLC after prior ICI and platinum therapy. Enrollment spans roughly 150 sites with the first site already open; the primary endpoint is overall survival, supported by FDA Fast Track designation. Results will shape CADL's long-term value trajectory.
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