Candel Therapeutics, Inc. CADL on Wednesday revealed final survival data from a phase 2a trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to Immune Checkpoint Inhibitor (ICI) treatment.

The median overall survival (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 (n=41) that presented with progressive disease at baseline, despite ICI treatment.

The company on Wednesday said 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.

This final analysis included extended follow-up data (1 year after the previous data cut), 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 (25.4 months in patients with progressive disease despite ICI treatment and non-squamous NSCLC, n=33).

Systemic anti-tumor response (abscopal effect) and safety profile:

• A decrease in the 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 (abscopal effect).
• CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period.

The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation for CAN-2409 plus valacyclovir in combination with ICI treatment for the treatment of stage III/IV NSCLC in patients who are resistant to first-line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.

Price Action: CADL is down 7.93% at $6.91 at the last check Thursday.

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