Abstract CT114 withheld due to inclusion in official press program, page-3

CAPRA RESULTS:

To date, 14 subjects have started on protocol therapy. Overall, the adverse events have been low-grade constitutional symptoms related to CVA21 and expected pembrolizumab-related side effects. No DLT’s have been reported. Currently, 11 patients are evaluable for investigator response assessment, not including 2 subjects who have not yet reached their first assessment and 1 subject who left the study early due to an unrelated adverse event. Among the evaluable subjects, the ORR was 73% (8/11). The DCR (CR+PR+SD) is currently 91% (10/11). In subjects with stage IVM1c disease, the ORR and the DCR is 100% (5/5). The study has met its primary statistical futility endpoint of achieving ≥2 confirmed objective responses (CR or PR) in the first 12 patients enrolled. Currently, the median time to response is 1.6 months. One of the 8 responders displayed early pseudo-progression and later developed a partial response.

At a pre-specified futility analysis, combination CVA21 and pembrolizumab appears to be well-tolerated. Early tumor monitoring has identified encouraging reductions in a number of injected and non-injected lesions. Based on these initial results, the sample size has now been expanded to enroll up to 50 patients. Combination therapy of CVA21 and pembrolizumab may represent a new approach for the treatment of patients with injectable advanced melanoma.

increasing the patient size to 50 patients is huge!