Candel Therapeutics announces final survival data from CAN-2409 trial

Candel Therapeutics (CADL) announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment. mOS was 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 and 21.5 months in evaluable patients from cohort 2 that presented with progressive disease at baseline, despite ICI treatment. mOS in patients with progressive disease despite ICI treatment, was 9.8-11.8 months in other studies, including those with standard of care of docetaxel chemotherapy, which has a very poor prognosis, did not exceed 12 months in other published studies. This final analysis included extended follow-up data with a median follow up time for the per protocol population of 32.4 months. Data showed a sizable percentage of patients with survival exceeding 24 months, evidence of a long tail of survival, with 37% of patients with progressive disease despite treatment with ICI alive 2 years after CAN-2409 administration. Biomarker research showed an enhanced immunological and clinical response after CAN-2409 administration in patients with non-squamous histology compared to squamous histology, and improved mOS was observed in this population. Pre-treatment and mid-treatment dropout rates were comparable to those reported in other clinical trials in similar populations of patients with advanced NSCLC. Three patients were enrolled, but did not receive treatment, 22 patients received only one injection of CAN-2409, 51 patients received at least 2 injections of CAN-2409, but 5 patients did not complete treatment. 46 patients received complete treatment and were included in the evaluable, per protocol population. The per protocol population was representative of the overall enrolled population in terms of baseline demographics and prognostic factors. In patients with an inadequate response to ICI treatment, mOS was 24.5 months. In patients with progressive disease, despite ICI treatment, mOS was 21.5 months, which is markedly longer than the 9.8-11.8 months of survival reported in published literature in a similar patient population receiving standard of care of docetaxel chemotherapy. 37% of patients exceeding 24 months survival were still alive at the time of the March 3, 2025 data cut. Patients with non-squamous histology predominated amongst the long-term survivors: 14/15 patients with OS greater than 24 months and 9/9 patients with OS greater than 30 months had non-squamous NSCLC. Patients with non-squamous histology exhibited larger changes in T cells, B cells, and dendritic cells after CAN-2409 administration compared to patients with squamous NSCLC. mOS of 25.4 months observed in non-squamous NSCLC patients with progressive disease, despite ICI treatment. Although a phase 2a open-label experimental medicine clinical trial is not designed for an intention to treat analysis, we conducted an exploratory ITT analysis and observed mOS of 16.7 months after CAN-2409 administration in non-squamous NSCLC patients with progressive disease despite ICI treatment. Recent trials have reported a mOS of 9.9-12.3 months in ICI-refractory, non-squamous NSCLC patients receiving standard of care docetaxel chemotherapy. Decrease in size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating that local injection may induce a systemic anti-tumor immune response. CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period.