Phase 2 Trial Update of PV-10 for Metastatic Melanoma
Provectus Pharmaceuticals announced top-line final data from its Phase 2 clinical trial of PV-10 for metastatic melanoma.
The data on response rate and progression free survival corroborated previously presented preliminary data on these topics. Key final data from the 80 subjects in the Phase 2 study include:
- An Objective Response Rate (OR) of 50% in subjects' target lesions (25% Complete Response and 25% Partial Response);
- 70% disease control in these lesions (combined Complete, Partial and Stable Response subjects);
- 33% of subjects having an untreated bystander melanoma lesion achieved an OR in their bystander lesions while 50% achieved disease control in these lesions;
- Response rates were analyzed by disease stage for the first time:
- Stage III subjects experienced a substantially higher response rate (58% OR and 81% disease control) vs. Stage IV subjects (22% and 33%, respectively);
- Similar trends were noted in response metrics for bystander lesions between these two subpopulations;
- Analysis of temporal data showed that Stage III subjects also experienced significantly greater mean Progression Free Survival (PFS) of at least 9.6 months, vs. 3.1 months for Stage IV subjects. Median PFS for Stage III subjects was not reached during the 12-month study interval;
- Higher response rates were noted among “evaluable subjects” (subjects that continued in the study for at least 8 weeks, enabling their responses to PV-10 to be assessed).
PV-10 is a novel oncology drug designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects.
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