8-K: Candel Therapeutics Announces Positive Survival Data for CAN-2409 in Advanced Lung Cancer

Candel Therapeutics reports positive final survival data from its Phase 2a clinical trial of CAN-2409 in patients with advanced non-small cell lung cancer (NSCLC) who have shown inadequate response to Immune Checkpoint Inhibitor (ICI) treatment.

Summary

• Candel Therapeutics announced positive final survival data from its Phase 2a clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) inadequately responding to Immune Checkpoint Inhibitor (ICI) treatment.
• The median overall survival (mOS) was 24.5 months in patients with an inadequate response to ICI treatment (Cohort 1+2, n=46).
• In patients with progressive disease despite ICI treatment (Cohort 2, n=41), the mOS was 21.5 months, exceeding the 9.8-11.8 months reported in similar populations receiving standard docetaxel chemotherapy.
• 37% of patients with progressive disease despite ICI treatment were still alive 2 years after CAN-2409 administration.
• Patients with non-squamous histology showed a mOS of 25.4 months, compared to 9.9-12.3 months in ICI-refractory non-squamous NSCLC patients receiving standard docetaxel chemotherapy.
• A decrease in the size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating a systemic anti-tumor immune response (abscopal effect).
• CAN-2409 maintained a favorable safety and tolerability profile throughout the extended follow-up period.
• The company plans to advance its development program for CAN-2409 in NSCLC, including preparation for a potentially registrational clinical trial in patients with non-squamous histology.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results, indicating a potential improvement in treatment outcomes for advanced NSCLC patients. The data suggests a significant survival benefit compared to existing treatments, which is likely to be viewed favorably by investors.

Positives

• CAN-2409 demonstrated prolonged median overall survival in advanced NSCLC patients non-responsive to ICI treatment.
• The treatment showed a long tail of survival, with a significant percentage of patients alive more than 2 years after administration.
• There is evidence of a systemic immune response with regression of both injected and uninjected lesions.
• CAN-2409 continued to exhibit a generally favorable safety and tolerability profile.
• The FDA previously granted Fast Track Designation for CAN-2409 plus valacyclovir in combination with ICI treatment for the treatment of stage III/IV NSCLC.

Risks

• The comparisons in mOS for NSCLC are not head-to-head.
• The forward-looking statements are subject to risks and uncertainties related to the timing and advancement of development programs, the therapeutic benefit of the Company's programs, and the Company's ability to obtain and maintain regulatory approval of product candidates.

Future Outlook

Candel plans to advance its development program for CAN-2409 in NSCLC, including preparation for a potentially registrational clinical trial in patients with non-squamous histology. The company also expects to submit a BLA for CAN-2409 in prostate cancer by Q4 2026.

Management Comments

• Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel, stated that CAN-2409 has the potential to extend survival for patients with advanced NSCLC who have limited treatment options after failing to respond to, or progressing, despite immune checkpoint inhibitor therapy.
• W. Garrett Nichols, MD, CMO of Candel, noted that the extension of survival in patients with non-squamous disease is notable even when compared to data that have been reported for other investigational products, such as antibody-drug conjugates, for this patient population.

Industry Context

The announcement highlights the need for new treatment options for NSCLC patients who do not respond adequately to immune checkpoint inhibitors, a significant portion of the NSCLC population. The results are being compared to standard of care docetaxel chemotherapy and other investigational products, such as antibody-drug conjugates.

Comparison to Industry Standards

• The mOS of 21.5 months in patients with progressive disease despite ICI treatment is markedly longer than the 9.8-11.8 months of survival reported in published literature for a similar patient population receiving standard of care docetaxel chemotherapy.
• 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, compared to the mOS of 25.4 months observed in non-squamous NSCLC patients with progressive disease, despite ICI treatment (n=33) in the CAN-2409 trial.
• The company compares its results to the TROPION-Lung01 Trial (AstraZeneca and Daiichi Sankyo) and EVOKE-01 Trial (Gilead).

Stakeholder Impact

• The positive survival data could improve treatment options and outcomes for NSCLC patients.
• Successful development and commercialization of CAN-2409 could benefit shareholders through increased company value.
• The company's advancement of its clinical programs could provide opportunities for employees.

Next Steps

• The company will advance its development program for CAN-2409 in NSCLC, including preparation and enabling work for a future, potentially registrational, clinical trial in patients with NSCLC with non-squamous histology.
• The company is undertaking preparatory activities for BLA submission and potential commercialization of CAN-2409 in prostate cancer.

Key Dates

Keywords

CAN-2409, NSCLC, immunotherapy, clinical trial, survival data, Candel Therapeutics, ICI treatment, lung cancer