Candel Therapeutics has identified a subpopulation of lung cancer patients living longest on its oncolytic virus, leading the biotech to narrow its focus as it heads towards a potentially registrational trial.
The phase 2a trial enrolled patients with advanced non-small cell lung cancer (NSCLC) who had an inadequate response to a checkpoint inhibitor. Candel accepted patients with squamous and non-squamous forms of lung cancer into the study. However, a review of long-term data on recipients of CAN-2409 has persuaded the biotech to bet on non-squamous NSCLC.
Candel’s decision is based on an analysis of patients who were still alive two years after starting treatment on CAN-2409. Fifteen patients passed that milestone. Fourteen of those patients had non-squamous lung cancer. All nine of the patients who were still alive after 30 months had non-squamous NSCLC.
The long-term survivors come from a cohort of 41 patients, 33 of whom had non-squamous cancer. In the non-squamous patients, the median overall survival (OS) was 25.4 months for a per-protocol population and 16.7 months in an exploratory intention-to-treat analysis. Candel compared the data to studies that linked standard-of-care chemotherapy to OS of 9.8 months to 11.8 months.
Candel shared immune data to support the idea that CAN-2409 works differently in non-squamous lung cancer. The biotech reported more pronounced changes in T cells, B cells and dendritic cells in its new target population than in people with squamous NSCLC.
Based on the data, Candel plans to prepare for a potentially registrational, clinical trial in patients with NSCLC with non-squamous histology. The narrowing of focus only costs Candel a slice of its previously targeted population, with the biotech estimating that non-squamous patients account for 70% to 75% of the NSCLC opportunity.