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Candel Therapeutics Announces Initiation of Global Pivotal Phase 3 AURORA Trial Evaluating Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors

CADL
  • Candel Therapeutics has initiated the global pivotal phase 3 AURORA trial (NCT07660094) to evaluate aglatimagene besadenovec plus valacyclovir combined with continued pembrolizumab versus standard-of-care docetaxel chemotherapy.
  • The trial targets patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) whose disease has progressed despite prior treatment with pembrolizumab & platinum-based chemotherapy.
  • The randomized, open-label study will enroll patients across approximately 150 sites worldwide using a 1:1 randomization scheme, with the first site now open for enrollment.
  • The primary endpoint of the AURORA trial is overall survival, while secondary endpoints include safety & quality-of-life assessments using NSCLC-SAQ & EORTC QLQ-30 instruments.
  • Parexel International has been engaged to support the clinical operations & execution of the trial across its global network of nearly 2,500 sites.
  • The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
  • The phase 3 trial builds on phase 2 data showing a median overall survival of 25.4 months in patients with non-squamous NSCLC & progressive disease despite prior immune checkpoint inhibitors.
  • Aglatimagene besadenovec is an investigational replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, converting valacyclovir into DNA-incorporating nucleotide analogs to induce immunogenic cell death.
  • Lung cancer remains the leading cause of cancer death in the U.S., with approximately 60% of patients experiencing disease progression within one year of first-line immune checkpoint inhibitor therapy.
  • Current standard-of-care docetaxel therapy delivers a median overall survival of only 9.8 to 11.8 months for patients with progressive disease following immune checkpoint inhibitors.