Trial reportJournal for immunotherapy of cancer2026
Prolonged survival after systemic immune reactivation by aglatimagene besadenovec plus valacyclovir in immune checkpoint inhibitor-refractory non-small cell lung cancer.
Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04495153 (CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
Abstract
backgroundPatients with advanced non-small cell lung cancer who progress on immune checkpoint inhibitors (ICIs) face limited options and poor survival. Aglatimagene besadenovec (CAN-2409), a replication-defective adenoviral vector encoding herpes simplex virus-thymidine kinase, plus valacyclovir, has been shown to induce immunogenic cell death and systemic immune activation.
methodsIn this open-label, phase 2a clinical trial, 76 patients were enrolled (intention-to-treat population) and 73 received at least one dose of aglatimagene besadenovec (safety population); 46 patients who received two intratumoral aglatimagene besadenovec injections, completed protocol-defined valacyclovir exposure, and underwent a 12-week imaging comprised the evaluable (per-protocol) population. Endpoints included clinical and immunological outcomes.
resultsIn the 73 patients included in the safety analysis (including patients who did not receive a second injection due to apparent pseudoprogression), median OS was 14.3 months. In the evaluable (per-protocol) population of 46 patients who completed protocol-defined treatment and week-12 imaging, median OS was 24.5 months (95% CI 16.0 to 33.8). Among the 41 evaluable patients in cohort 2, 15 (37%) were alive at ≥24 months and 5 (12%) at ≥40 months. In the 46-patient evaluable population, the objective response rate was 10.9% (5/46; 95% CI 4.7% to 23.0%) and the disease control rate was 71.7% (33/46; 95% CI 57.5% to 82.7%). In the 73 patients included in the safety analysis (including patients who did not receive a second injection due to apparent pseudoprogression) median overall survival was 14.3 months. Exploratory biomarkers demonstrated systemic immune reactivation, including cytotoxic T-cell expansion and regression of uninjected lesions, with stronger signals in non-squamous histology. No grade 4 treatment-related adverse events or treatment-related deaths were reported. Most treatment-related adverse events were grade 1-2; 10/73 patients (13.7%) experienced grade 3 treatment-related adverse events. Six patients discontinued because of adverse events, including two with events considered possibly related to treatment (including ongoing ICI).
conclusionsIn this single-arm phase 2a study, aglatimagene besadenovec plus valacyclovir with ongoing ICI was associated with systemic immune remodeling and encouraging survival. Because comparisons with historical controls are descriptive and vulnerable to selection and other biases, efficacy requires confirmation in a randomized controlled clinical trial, which has been initiated. TRIAL REGISTRATION NUMBER: NCT04495153.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.