NEEDHAM, Mass. — October 1, 2026

Candel Therapeutics announced the publication of final Phase 2a clinical trial results evaluating aglatimagene besadenovec plus valacyclovir in patients with unresectable Stage III/IV non-small cell lung cancer (NSCLC) who had an inadequate response to immune checkpoint inhibitors (ICI). Published in the Journal for ImmunoTherapy of Cancer, the study reported a median overall survival of 24.5 months in the evaluable population. The trial evaluated 46 patients who received two courses of aglatimagene plus valacyclovir alongside continued ICI therapy. Among 41 patients with progressive disease at baseline despite ICI treatment, median overall survival was 21.5 months, while 37% remained alive beyond 24 months at the data cutoff. The findings provide clinical and mechanistic evidence for Candel’s investigational multimodal immunotherapy approach in a patient population with limited treatment options following ICI failure.

Candel Reports Survival Data in Advanced NSCLC

The Phase 2a results showed prolonged survival across several patient subgroups, with non-squamous NSCLC emerging as an important population in exploratory analyses. Among 33 evaluable patients with non-squamous histology and progressive disease despite ICI therapy, median overall survival reached 25.4 months. Fourteen of 15 patients who survived beyond 24 months and all nine patients who survived beyond 30 months had non-squamous disease. In the intention-to-treat analysis of non-squamous patients, median overall survival was 16.7 months, compared with a published 12.3-month benchmark for docetaxel in this setting. Candel noted that standard-of-care docetaxel has historically produced median overall survival of approximately 9.8 to 11.8 months in patients whose disease progresses after ICI treatment, although cross-trial comparisons have limitations. The company is evaluating whether the observed survival findings can be confirmed in its ongoing pivotal development program.

Aglatimagene Activates Systemic Antitumor Immunity

Mechanistic analyses indicated that aglatimagene treatment produced systemic immune activation beyond the injected tumor lesions. Among 35 evaluable patients with more than one tumor lesion, 69% demonstrated systemic clinical responses with reductions in uninjected lesions, consistent with an abscopal response. Biomarker analyses showed increased cytotoxic T-cell infiltration within tumor tissue, expansion of activated CD8+ effector and central memory T cells in peripheral blood, and increased serum levels of granzymes following treatment. The changes were particularly pronounced after the second administration of aglatimagene. Multi-omics analysis also identified coordinated immune-activation patterns associated with improved survival, while patients surviving beyond 24 months showed higher levels of immune markers including granzyme B and granzyme H. These findings support the proposed mechanism in which localized treatment is intended to stimulate a broader systemic antitumor immune response.

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Candel Advances Phase 3 AURORA Trial

The Phase 2a publication supports Candel’s ongoing Phase 3 AURORA trial, which is evaluating aglatimagene plus valacyclovir in combination with continued pembrolizumab versus standard-of-care docetaxel. The global study is enrolling patients with metastatic Stage IV non-squamous NSCLC whose disease has progressed despite prior pembrolizumab and platinum-based chemotherapy and is being conducted across approximately 150 sites worldwide. Aglatimagene is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene directly into tumors. Combined with valacyclovir, the approach is designed to promote immunogenic tumor-cell death and release tumor antigens while stimulating inflammatory signaling. Candel reported that treatment in the Phase 2a study was generally well tolerated, with mostly Grade 1 and 2 flu-like adverse events and 13.7% of patients experiencing Grade 3 treatment-related adverse events. No dose-limiting toxicities or unexpected safety signals were identified during extended follow-up. Aglatimagene remains investigational and is not approved by the FDA or other regulatory authorities.

Source:Candel Therapeutics,, press release