I think Dr. Agarwala raises a key point. Many Phase 2 patients in Provectus' PV-10 trial were elderly, and received multiple prior therapies and treatment for melanoma that did not work (a "fairly refractory group of patients"). See below; the median number of prior treatments was 6.
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"Of the 13 consented patients [in Moffitt's feasibility study], 5 had no previous treatment, 6 received ILI or ipilimumab [sold as Yervoy], and 2 received PD-1 blocking antibody; 6 received two or more prior systemic therapy." ILI refers to isolated limb infusion. Other systemic therapies included vemurafenib (sold as Zelboraf), temozolomide or "TMZ" (an orally administered systemic chemotherapy), and carbotaxol (another systemic chemotherapy).
It would seem Provectus' pivotal Phase 3 trial may prove PV-10 has the potential to be better (much better) than what's available today and on the horizon for patients, both in terms of "new melanoma drugs" (e.g., anti-CTLA-4, BRAF and anti-PD-1 agents) and standards of care (i.e., systemic chemotherapy). In particular, the trial would take patients that have progressed on systemic immunotherapies (i.e., anti-CTLA-4 and anti-PD-1 agents), have not responded to them, or cannot receive them.