On September 11, 2018 Provectus (OTCQB: PVCT) reported that data from two ongoing clinical trials, single agent PV-10 and PV-10 in combination with checkpoint inhibition for the treatment of uveal melanoma metastatic to the liver (an expansion cohort of NCT00986661) and PV-10 in combination with checkpoint inhibition for the treatment of metastatic melanoma (NCT02557321), will be presented in poster presentations at the SMR 2018 Congress (the Society for Melanoma Research annual meeting), held in Manchester, England from October 24-27, 2018 (Press release, Provectus Biopharmaceuticals, SEPT 11, 2018, View Source [SID1234529387]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The accepted abstracts are entitled:
"Percutaneous Oncolytic Rose Bengal Disodium for Metastatic Uveal Melanoma Patients with Hepatic Metastases," and
"Interim Results of a Phase 1b/2 Study of PV-10 and Anti-PD-1 in Advanced Melanoma."
Presentation details will be announced closer to the SMR 2018 Congress.
About Metastatic Uveal Melanoma
Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.1,2 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with the liver as the first site of disease involvement.1,2,3 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.4
About our Phase 1 Study of PV-10 for Cancers Metastatic to the Liver
Provectus’ ongoing, open-label, Phase 1 study is evaluating the safety, tolerability, and preliminary efficacy of PV-10 in patients with solid tumors metastatic to the liver. A single percutaneous injection of PV-10 is administered to a designated hepatic tumor. Response assessments are performed at Day 28, and then every three months. Patients with multiple injectable tumors may receive additional PV-10 after Day 28.
This study also includes a single-center cohort of 10 uveal melanoma patients with hepatic metastases. This site is MD Anderson Cancer Center in Houston, Texas, and the principal investigator for the basket study’s new cohort is Sapna Patel, MD. Eligible patients may also receive standard of care checkpoint blockade immunotherapy during treatment with PV-10.
About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Metastatic Melanoma
Patients with metastatic melanoma having at least one injectable cutaneous or soft tissue lesion were eligible for participation in the Phase 1b portion of the study and received the combination of IL PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability. Objective response rate and progression-free survival are key secondary endpoints; both are assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter.
Preliminary results were presented at the Society for Melanoma Research 2017 Congress in October 2017. Enrollment in the Phase 1b portion of this study was completed in May 2018.
About PV-10
Provectus’ lead investigational oncology drug product, 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.