On June 8, 2022 Provectus (OTCQB: PVCT) reported that updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver (mUM) in its cancers-of-the-liver Phase 1 trial of investigational immunocatalyst PV-10 (rose bengal sodium) (NCT00986661) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, held June 3-7 in Chicago, Illinois and online (Press release, Provectus Biopharmaceuticals, JUN 8, 2022, View Source [SID1234615772]).

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Twenty-nine percent (29%) of Stage IV M1a mUM patients achieved mCR and were alive from 12.4+ to 48.8+ months after starting PV-10 treatment. All M1a patients had hepatic metastases injected with PV-10; 50% had extrahepatic disease, which was not injected with PV-10. A portion of M1a patients underwent positron emission tomography (PET)-computed tomography (CT) (PET-CT) cancer imaging, which previously has not been widely recognized as an important tool for monitoring tumor response in mUM because historical treatments essentially did not produce mCRs.

This ongoing single-center mUM study at MD Anderson Cancer Center (MDACC) in Houston, Texas has been led since inception by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine at MDACC. Up to three hepatic mUM tumors can be injected per PV-10 treatment cycle. Response assessments are performed at Day 28, and then every three months. Patients with additional, injectable, visceral hepatic mUM disease may receive additional cycles of PV-10 after Day 28. Eligible patients may also receive standard of care immune checkpoint blockade (CB; i.e., either PD-1 or combination CTLA-4 + PD-1) during and after PV-10 treatment.

Highlights from the ASCO (Free ASCO Whitepaper) presentation, with data supplementation

PV-10 can induce mCR in injected/adscopal and non-injected/abscopal lesions.
mCR suggests immunogenic cell death in mUM patients with non-injected liver metastases.
RECIST response assessment may underestimate the effect of PV-10 in injected tumors. 2D EASL is more sensitive than RECIST to changes in injected lesions. PET-CT is more sensitive than either RECIST or 2D EASL.
Translational research is underway at MDACC and Moffitt Cancer Center to elucidate the molecular basis for mCR responders vs non-responders.
A copy of the ASCO (Free ASCO Whitepaper) poster presentation is available on Provectus’ website at: View Source

Ed Pershing, Chair of Provectus’ Board of Directors (Board), said, "We could not be more grateful to these study patients, their families and caregivers, the MD Anderson Cancer Center clinical trial team, and the ocular melanoma patient advocacy community for the opportunity to better develop a comprehensive approach for identifying, surveilling, treating, and hopefully defeating this terrible disease in its early metastatic stage. We have gained valuable insights from this clinical trial that will be considered for future patient assessment and treatment protocols, as we continue to advance PV-10 for the treatment of metastatic uveal melanoma."

Dominic Rodrigues, Vice Chair of the Board, added, "These clinical trial data show that, while PV-10 can contribute to treatment efficacy across all disease stages, PV-10 may have much greater impact on early-stage metastatic uveal melanoma. It is important to note that patients do not typically present with M1a, M1b, or M1c disease, and that staging of study participants is based on the status of their metastatic disease course at the start of PV-10 treatment. The outcome in M1a patients who achieved a metabolic complete response implies that early intervention can be critical, and that surveillance techniques like PET imaging can play an essential role in identifying metastatic status and assessing treatment response."

Mr. Rodrigues concluded, "Metastatic uveal melanoma can be particularly threatening once it takes hold at metastatic sites around the body. These study data give us a level of confidence that the potential exists to provide a survival benefit to patients with metastatic disease by leveraging standard of care immunotherapy in combination with PV-10, and to finalize the development of a PV-10-led approach that could offer durable responses in patients by proactively integrating assessment and treatment methodologies earlier and not waiting for a patient’s disease to get out of control."