On January 29, 2019 Provectus (OTCQB: PVCT) reported that the Journal of Surgical Oncology (JSO) has published results from an investigator-conceived and led, single-center study of in-transit melanoma (ITM) patients receiving either regionally-administered isolated limb infusion (ILI) or intratumoral (aka intralesional) PV-10 to assess and compare the effect of these treatments on survival (Press release, Provectus Biopharmaceuticals, JAN 29, 2019, View Source [SID1234532943]). The JSO article detailed the work of investigators at the Princess Alexandra Hospital (PAH) in Brisbane, Australia, where ILI represents the historical standard of care for ITM and PV-10 was used to treat ITM under expanded access. Intratumoral injection of PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1,2,3,4

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This article, entitled "Patients with in-transit melanoma metastases have comparable survival outcomes following isolated limb infusion or intralesional PV-10 – A propensity score matched, single center study," may be accessed via the JSO’s website at View Source

Key Results from the JSO Article:

Baseline and disease characteristics:

Patients matched for key covariates: age, gender, primary disease site, and Breslow thickness
ILI: 36 patients; 56% men; median age of 76.5 years (interquartile range 69-83); 100% Stage IIIB/IIIC
PV-10: 36 patients; 56% men; median age of 74.5 years (65-81); 89% Stage IIIB/IIIC (11% Stage IV)

Treatment response (patient-level best overall response):

ILI: 22% complete response and 50% overall response rate
PV-10: 25% complete response and 83% overall response rate

Survival outcomes:

ILI
progression-free survival (PFS): median of 5.0 months (interquartile range 2.7-10.7)
disease-free survival (DFS): median of 16.5 months (8.9-48.4)
overall survival (OS): median of 29.7 months (12.3-88.5)
melanoma-specific survival (MSS): median of 74.4 months (24.3-NA); 12‐, 24‐, 36‐, and 60‐month MSS rates of 85%, 75%, 60%, and 60%, respectively
PV-10
PFS: median of 3.9 months (9.6-47.9)
DFS: median of 14.1 months (4.5-20.9)
OS: median of 27.1 months (14.3-48.6)
MSS: median of 36.4 months (16.6-65.3); 12‐, 24‐, 36‐, and 60‐month MSS rates of 83%, 70%, 54%, and 36%, respectively
Differences in PFS, DFS, and MSS comparing ILI with PV‐10 were not statistically significant
Among the authors’ conclusions:

"Overall these results demonstrate that demographically similar patients with in-transit melanoma metastases treated with ILI or PV-10 have comparable long-term survival rates,"

"Propensity score matching is a useful statistical technique for examining relative treatment effects within complex patient groups, particularly when larger randomized controlled studies are impractical,"

"A complete response to either treatment was the only independent factor identified that significantly predicted long-term survival,"

"These findings suggest that both ILI and PV‐10 can be considered as a suitable standard of care," and

"These treatments are relevant and likely to remain of value in the near future, particularly for the treatment of symptomatic or refractory metastases following the discontinuation of systemic therapies due to serious drug-related side-effects or exhaustion of other systemic options."
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Despite the advances made by targeted therapies and checkpoint inhibitors, these comparative survival data highlight the important role that investigational PV-10 may have for the treatment of advanced melanoma. The Australian investigators place PV-10’s role in the context of relatively more expensive systemic agents that have substantial toxicity profiles and similar response rates."

Mr. Rodrigues added, "Furthermore, these comparative survival data substantiate the Company’s historical work in melanoma and provide more validation of PV-10 in a single-agent setting for a challenging patient population. The key focus of Provectus’ drug development program now is to demonstrate PV-10 activity in both single-agent and combination therapy settings for the treatment of both hot and cold tumor types."

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.