Candel Therapeutics Inc (NASDAQ:CADL) has reported updated clinical data showing extended survival outcomes from its ongoing phase 2a trial of aglatimagene besadenovec (CAN-2409) in patients with advanced non-small cell lung cancer (NSCLC) who had previously shown an inadequate response to immune checkpoint inhibitors (ICIs).
The additional 12 months of follow-up data indicate that 50% of the 46 patients in the per-protocol population remained alive at 24 months after treatment.
Longer-term survival was also observed, with 35% of patients surviving beyond 30 months, 26% beyond 36 months, 24% beyond 40 months, and 13% exceeding 50 months. These figures represent an improvement compared to an earlier data cut, which showed 39% survival at 24 months.
Median overall survival (mOS) reached 25.4 months among evaluable patients across cohorts 1 and 2. In a subgroup of patients with progressive disease despite prior ICI therapy, mOS was 21.5 months, while patients with non-squamous histology in this cohort also recorded mOS of 25.4 months. According to the company, these outcomes compare with historical mOS ranges of approximately 9.8 to 11.8 months for similar patients receiving standard-of-care docetaxel.
Additionally, biomarker analyses suggested immunological changes associated with treatment. Among long-term survivors with available PD-L1 data, 85% had baseline PD-L1 tumor proportion scores below 50%, a group that typically responds less effectively to ICIs. Post-treatment tumor biopsies showed increased expression of pro-inflammatory genes and activation of immune-related pathways, including interferon signaling and antigen presentation.
The company also reported expansion of T-cell receptor diversity in both tumor tissue and peripheral blood following treatment, which may indicate a broader anti-tumor immune response.
Candel said aglatimagene continued to demonstrate a generally favorable tolerability profile over the extended follow-up period.
“These updated survival data further strengthen our previously reported findings, demonstrating the potential of aglatimagene to meaningfully extend survival for patients with advanced NSCLC who have limited treatment options after failing to respond to, or progressing despite, ICI therapy,” Candel Therapeutics CEO Dr Paul Peter Tak said in a statement.
“With its differentiated mechanism of action and favorable safety profile observed to date, aglatimagene represents a novel therapeutic approach for solid tumors, with the potential to improve outcomes beyond current standards of care.
Based on the findings, the company plans to initiate a pivotal phase 3 trial in the second quarter of 2026, focusing on patients with NSCLC with non-squamous histology.
The investigational therapy has previously received Fast Track designation from the US Food and Drug Administration for use in combination with ICIs in certain patients with advanced NSCLC.
Shares of Candel rose 4% on Tuesday morning.