KNOXVILLE, TN, Sept. 21, 2021 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) 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 European Society for Medical Oncology (ESMO) Congress, held online from September 16-21, 2021.
Highlights from the ESMO 2021mNET Presentation:
- Baseline disease characteristics
- N = 12 patients: 50% male; median age of 66 years (range 47-79)
- Primary tumor sites: 7 small bowel (58%), 2 pancreas (17%), 1 caecal (8%), and 2 unknown (17%)
- NET grades: 5 Grade 1 (42%) and 7 Grade 2 (58%)
- Refractory to SSA and PRRT; all symptomatic progressive disease
- Chromogranin A (CgA): median 1,585 μg/L (35-10,370)
- PV-10 treatment
- Median number of injected lesions: 1 (1-4)
- Median number of injection cycles: 1 (1-4); 8 patients (67%) received 1 PV-10 cycle; 4 patients received multiple cycles
- Safety
- Injection site pain in 9 of 12 patients (75%)
- Grade 3 photosensitivity reaction in 1 patient; Grade 3 elevation of hepatic enzymes in 1 patient (resolved by Day 7); carcinoid flare in 2 patients
- Injected-lesion efficacy (RECIST)
- 42% partial response (PR) and 42% objective response rate (ORR)
- Patient-level efficacy (RECIST)
- 83%a disease control rate (DCR) (10 of 12 patients)
- Median progression-free survival (PFS): 9.2 months (1.0-41.8)
- Median overall survival (OS): 22.5 months (5.5-41.8); 6 patients (50%) undergoing response follow-up (data cut-off: April 30, 2021)
- Immune response
- Upregulation of NK cells and activated CD4+ T cells observed in peripheral blood collected 7-28 days post-PV-10 injection
- Biomarkers and quality of life (QOL)
- CgA stable in 10 patients (83%)
- Health-related QOL assessments stable or improved at one month in 8 of 11 patients (73%); maintained at 3 months in 6 of 10 patients (60%)
a Typographical error on the poster
A copy of the poster is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/Phase_1_NET.ESMO-2021.pdf.
Simone Leyden, Chief Executive Officer and Co-Founder of NeuroEndocrine Cancer Australia, and International Neuroendocrine Cancer Alliance (INCA) Research Chair, said “The safety and efficacy data from this Phase 1 clinical trial of single-agent PV-10 present a promising therapy for refractory, symptomatic, neuroendocrine cancer patients with liver metastases, a patient population who are underrepresented when it comes to new medical research and treatment options. We look forward to seeing PV-10’s future use in this refractory setting, and also in Phase 2 combination therapy testing for earlier lines of neuroendocrine cancer treatment.”
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