Candel Launches Phase 3 AURORA Trial in NSCLC

Candel Therapeutics has initiated the global pivotal Phase 3 AURORA trial evaluating its investigation of viral immunotherapy aglatimagene besadenovec (CAN-2409) in patients with advanced non-small cell lung cancer whose disease has progressed despite prior immune checkpoint inhibitor therapy. Reported on 2 July 2026, the trial addresses a well-recognised unmet need with poor current survival outcomes and follows encouraging Phase 2 data that showed a marked overall survival benefit versus historical docetaxel comparators.

The randomized, open-label AURORA trial (NCT07660094) will enroll patients with metastatic stage 4 non-squamous NSCLC whose disease has progressed despite pembrolizumab-based immunotherapy and platinum-based chemotherapy, across approximately 150 sites worldwide. Patients will be assigned 1:1 to receive either intratumoral aglatimagene besadenovec plus oral valacyclovir and continued pembrolizumab, or standard-of-care docetaxel chemotherapy. Overall survival is the primary endpoint. CAN-2409 previously received FDA Fast Track designation in NSCLC.

CAN-2409 is a replication-defective adenoviral vector that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumors. Patients then receive oral valacyclovir, which is converted into cytotoxic nucleotide analogs within tumor cells expressing HSV-tk, generating immunogenic tumor cell death and a systemic CD8-positive T-cell response targeting both injected and distant metastatic lesions. In Phase 2, 50% of per-protocol patients remained alive beyond 24 months, with a median overall survival of 25.4 months in the non-squamous ICI-progressed subgroup, versus 9.8 to 11.8 months typically reported for docetaxel post-immunotherapy. Roy Herbst, deputy director at Yale Cancer Center, is co-principal investigator, with more than 1,000 patients having received CAN-2409 across clinical studies.

The commercial signal is significant. If AURORA replicates the Phase 2 survival benefit, CAN-2409 becomes the first viral immunotherapy to demonstrate a survival benefit in the large post-ICI NSCLC population, opening a potentially lucrative second-line lung cancer indication. Expect increased strategic interest from major oncology players, particularly given the combination with Merck’s Keytruda, which retains commercial primacy in first-line NSCLC.

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