Candel Therapeutics Reports Both Prolonged Median Overall Survival and Long Tail of Survival in Phase 2a Clinical Trial of CAN-2409 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Non-Responsive to Immune Checkpoint Inhibitor (ICI) Treatment

Core Insights - Candel Therapeutics announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) who inadequately responded to immune checkpoint inhibitor (ICI) treatment, showing a median overall survival (mOS) of 24.5 months in evaluable patients [1][5] - The study demonstrated a significant survival benefit compared to standard treatments, with 37% of patients with progressive disease alive two years after CAN-2409 administration [1][5] - The treatment showed improved mOS in non-squamous NSCLC patients, with a mOS of 25.4 months observed in this subgroup [2][5] Clinical Trial Results - The final analysis included 46 evaluable patients, with a median follow-up time of 32.4 months, revealing a long tail of survival [1][4] - Patients with progressive disease at baseline had a mOS of 21.5 months, significantly exceeding the 9.8-11.8 months reported for standard docetaxel chemotherapy [5][8] - A systemic immune response was observed in approximately two-thirds of patients, indicating an abscopal effect [5][8] Safety and Tolerability - CAN-2409 maintained a favorable safety and tolerability profile throughout the extended follow-up period, with no new safety signals identified [5][8] - Dropout rates during the trial were comparable to other clinical trials in similar populations, indicating the treatment's feasibility [4][6] Future Development - Based on positive findings, Candel plans to advance the development program for CAN-2409, including preparations for a potentially registrational clinical trial in NSCLC patients with non-squamous histology [7][10] - The FDA has granted Fast Track Designation for CAN-2409 in combination with ICI treatment for stage III/IV NSCLC patients resistant to first-line therapy [7][10] About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to induce a systemic immune response against tumors [8][9] - The treatment has shown encouraging activity in various solid tumors and has been well tolerated in over 1,000 patients [9][11]