On March 16, 2022 Provectus (OTCQB: PVCT) reported that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the annual conference of the European Neuroendocrine Tumor Society (ENETS), held from March 10-11, 2022 in a hybrid setting in Barcelona, Spain and online (Press release, Provectus Biopharmaceuticals, MAR 16, 2022, View Source [SID1234610179]).
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The oral presentation was made by the principal investigator of the clinical trial’s single center at The Queen Elizabeth Hospital (TQEH) in Adelaide, Australia: Tim Price, MBBS, DHlthSc (Medicine), FRACP, Head of Clinical Oncology Research and Chair of the combined Hematology and Medical Oncology Unit at TQEH, and Clinical Professor in the Faculty of Medicine at the University of Adelaide.
Highlights from the 2022 ENETS Presentation:
Patient characteristics
N = 12 patients: 50% male; median age of 66 years (range 47-79)
Primary tumor sites: 7 small bowel (58%), 3 pancreas (25%), 1 caecal (8%), and 1 unknown (8%; likely pancreas)
NET grades: 5 Grade 1 (42%) and 7 Grade 2 (58%)
All patients were refractory to SSA (100%), and 11 received PRRT (92%) as part of their prior treatment
All patients had symptomatic, progressive disease
Baseline chromogranin A (CgA): median 1,585 µg/L (range 35-10,370)
PV-10 treatment
4 patients (33%) received more than 1 dose (range 2-4)
8 patients (67%) received 1 dose
Safety
All treatment-emergent adverse events (TEAEs) were Grade 1 or 2, primarily injection site pain (75%)
Single subjects experienced Grade 3 TEAEs of photosensitivity reaction or transaminases increased
Efficacy
Median progression-free survival (mPFS): 9.4 months (range 1.0-41.8)
Median overall survival (mOS): 22.5 months (range 5.5-42.3); 4 patients alive
Subgroup analysis of primary NET histology, pancreas vs intestine: mPFS 2.7 months vs 19.7 months; mOS 11.8 months vs 25.5 months
Quality of life (QOL)
Stable or improved health status and symptoms after 3 months in most patients
A recording of Dr. Price’s presentation and a copy of his slides are available on Provectus’ website at View Source
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Study data continue to show encouraging local and systemic disease control, as well as symptom control, in a heavily pre-treated population and to support a role for monotherapy PV-10 as a treatment for neuroendocrine cancer patients who fail standard therapy."
Mr. Rodrigues added, "PV-10-led combination therapies for neuroendocrine cancer patients may represent opportunities to improve quality of life and clinical outcomes. Front-line approaches may include combining liver-directed PV-10 therapy with systemically-delivered immune checkpoint inhibitors to enhance PV-10’s immune mechanisms, or using PV-10 to enhance the activity of cytotoxic treatments such as peptide receptor radionuclide therapy."
About PV-10
Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory disease, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with melanoma and cancers of the liver in both monotherapy and combination therapy settings. IL PV-10 is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors.
Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a therapeutic treatment for relapsed and refractory blood cancers.