Provecta: Phase II final data

Final data from the open-label, U.S. and Australian Phase II PV-10-MM-02 trial in 80 patients with stage III or IV melanoma showed that intralesional PV-10 produced an ORR of 49%, with 24% of patients achieving a complete response, 25% a partial response and 18% achieving stable disease (SD). Mean PFS was 8.2 months for all patients. Patients who had an objective response to PV-10 had a mean PFS of 11.7 months vs. 4.1 months for patients with SD or progressive disease. Additionally, PV-10 produced an ORR of 37% in patients with an untreated bystander lesion at baseline, with 55% achieving SD or better. Furthermore, 67% of patients achieved an objective response of their bystander lesions if they achieved an objective response in their injected lesions vs. 5% of patients who did not achieve an objective response in their injected lesions. ...