PV-10 Data Published; Phase 3 Protocol Published
11/21/2014
Phase II data for PV-10 (Provectus Biopharmaceuticals, Inc.), presented at scientific meetings this fall, were published in Annals of Surgical Oncology in October. In the 80-subject study, the best overall response rate for target lesions was 51 percent, and the complete response rate was 26 percent. Eight percent of patients had no evidence of disease after 52 weeks. Response was dependent on untreated disease burden, with complete response achieved in 50 % of patients receiving PV-10 to all of their disease. Adverse events were predominantly mild to moderate and locoregional to the treatment site, with no treatment-associated grade 4 or 5 adverse events. The study was an international, multicenter, open-label, single-agent study.
Also this fall, Provectus published online the protocol for Phase 3 Study Of PV-10 as treatment for melanoma. The study is “an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months. Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); the change in total symptom score from baseline using the patient reported Skindex-16 instrument (to be assessed 12 weeks after Day 1); Overall survival (OS) to be assessed every 12 weeks up to 18 months; and number of participants with adverse events assessed every 4 weeks until 28 days after last treatment.
Also this fall, Provectus published online the protocol for Phase 3 Study Of PV-10 as treatment for melanoma. The study is “an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months. Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); the change in total symptom score from baseline using the patient reported Skindex-16 instrument (to be assessed 12 weeks after Day 1); Overall survival (OS) to be assessed every 12 weeks up to 18 months; and number of participants with adverse events assessed every 4 weeks until 28 days after last treatment.