Candel Therapeutics Reports Extended Survival in NSCLC: 50% of Patients Survive Over 24 Months with CAN-2409 After Immune Checkpoint Failure
Durable Long-Term Survival Observed in Difficult-to-Treat NSCLC Patients
Candel Therapeutics announced new results from its phase 2a trial showing that advanced non-small cell lung cancer (NSCLC) patients who had not responded to immune checkpoint inhibitors (ICI) achieved notable long-term survival when treated with aglatimagene besadenovec (CAN-2409). Among 46 patients in the per-protocol population, half (23 patients) survived at least 24 months, while 35% made it past 30 months. Even more striking, 13% lived over 50 months. These results mark a meaningful improvement over prior data, offering new hope for a population with historically limited options.
| Timepoint | Patients Surviving (%) |
|---|---|
| 24 months | 50% |
| 30 months | 35% |
| 36 months | 26% |
| 40 months | 24% |
| 50 months | 13% |
Median Survival Outpaces Standard Therapy, Especially for ICI-Resistant Population
Median overall survival (mOS) reached 25.4 months in the evaluable group, and 21.5 months in patients who had progressive disease at baseline (a particularly hard-to-treat category). For those with non-squamous histology, mOS climbed to 25.4 months. By comparison, patients receiving standard-of-care docetaxel after failing ICI therapy historically have mOS of just 9.8-11.8 months—making CAN-2409's results a roughly twofold improvement.
| Patient Subgroup | Median Overall Survival (months) | Historical mOS (months) |
|---|---|---|
| All evaluable patients (CAN-2409) | 25.4 | 9.8-11.8 |
| Progressive disease at baseline | 21.5 | 9.8-11.8 |
| Non-squamous histology | 25.4 | 9.8-11.8 |
Biomarker Data Suggests CAN-2409 Converts "Cold" Tumors into Responsive Immune Environments
Of those surviving over 24 months, 85% (17 of 20 patients with available data) had baseline tumor PD-L1 expression below 50%—a marker typically associated with poor responses to ICI therapy. This suggests that CAN-2409 may help turn ICI-resistant tumors into ones capable of mounting an immune response.
Biopsies confirmed increases in pro-inflammatory gene activity, including interferon signaling and antigen presentation, correlating strongly with the long-term survivors. Markers such as IFN?, CSF1, CX3CL1, and IL1 were all significantly elevated. Additionally, after CAN-2409 treatment, there was measurable expansion in T-cell receptor (TCR) diversity in both tumors and circulating blood, indicating enhanced immune engagement.
Tolerability Profile Remains Favorable, Supporting Path Forward
CAN-2409 maintained a generally favorable tolerability profile, with over 1,000 patients having received the therapy in clinical trials. This safety record—together with efficacy and biomarker findings—supports plans for a pivotal phase 3 trial beginning in Q2 2026, focused on non-squamous NSCLC with resistance to current immunotherapies. CAN-2409 also holds multiple regulatory designations, including Fast Track and Orphan Drug status for various cancers.
Key Takeaways for Investors and the Scientific Community
The latest data from Candel Therapeutics highlight CAN-2409’s potential as a new therapeutic option for advanced NSCLC patients who have failed standard immunotherapy. The extended survival, strong mechanistic rationale, and ability to convert "cold" tumors suggest broader applicability for CAN-2409 in cancer therapy. With a pivotal phase 3 trial on the horizon, investors and clinicians alike will be watching closely to see if these promising trends continue—and whether CAN-2409 could help define a new standard in multi-modal immunotherapy for solid tumors.
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