Candel Therapeutics Announces Publication of Phase 2a Trial Data that Demonstrated Prolonged Survival after Systemic Immune Reactivation by Aglatimagene Besadenovec plus Valacyclovir in Patients with Unresectable Stage III/IV NSCLC with an Inadequate Response to ICI
Key Highlights
- ➤Median overall survival 24.5 months in evaluable advanced NSCLC patients after inadequate ICI response
- ➤Cohort 2 median overall survival 21.5 months among 41 patients progressing on ICI
- ➤Non-squamous progressive-disease patients achieved median overall survival of 25.4 months
- ➤Phase 3 AURORA trial enrolling globally across approximately 150 sites
- ➤Grade 3 treatment-related adverse events occurred in 13.7% of patients
Expert Statements
Charu Aggarwal, Leslye Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine and lead investigator of the trial
“These peer-reviewed results confirm that aglatimagene has the potential to extend survival for patients with advanced non-small cell lung cancer who have limited options after immune checkpoint inhibitors fail to control their cancer.”
Charu Aggarwal, Leslye Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine and lead investigator of the trial
“The magnitude of benefit observed, particularly in patients with non-squamous disease, is striking, and represents an important potential advance for this patient population.”
Paul Peter Tak, President and Chief Executive Officer of Candel
“Aglatimagene’s ability to reinvigorate anti-tumor immunity in checkpoint-refractory patients through a systemic immune response, combined with its favorable safety profile, positions this approach as a potentially transformative option for patients with limited therapeutic alternatives.”
Paul Peter Tak, President and Chief Executive Officer of Candel
“These results support the advancement of our pivotal phase 3 AURORA trial, which is enrolling patients globally.”
* Peer-reviewed publication in Journal for ImmunoTherapy of Cancer reports median overall survival of 24.5 months in advanced non-small cell lung cancer (NSCLC) patients with inadequate response to immune checkpoint inhibitors (ICI) NEEDHAM, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the publication of final phase 2a clinical trial results (NCT04495153) of aglatimagene besadenovec (aglatimagene) plus valacyclovir in patients with stage III/IV NSCLC who had shown inadequate response to ICI. The trial demonstrated a median overall survival (mOS) of 24.5 months in the evaluable population, substantially exceeding historical benchmarks for standard-of-care docetaxel chemotherapy in this patient population.
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