P-116 - Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter S. Agarwala
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors S. Agarwala1, P. Goldfarb2, R. Low2, J. Lyon2, A. Rosemurgy3, E. Wachter4
  • 1Easton/US
  • 2San Diego/US
  • 3Tampa/US
  • 4Knoxville/US

Abstract

Introduction

Intralesional PV-10, a 10% solution of rose bengal, has recently demonstrated high rates of complete response and durable local control in metastatic melanoma. The current Phase 1 study is assessing safety, pharmacokinetics, and preliminary efficacy of PV-10 in subjects with non-resectable hepatocellular carcinoma or cancer metastatic to the liver.

Methods

Subjects having at least one liver tumor ≥ 1 cm are administered a single percutaneous intralesional injection of PV-10 to one Target Lesion at dose of 0.25 or 0.50 mL per cm3 lesion volume. Plasma concentrations of PV-10 from 1 hour to 28 days after injection are measured. Radiologic assessments of the injected Target Lesion are performed to determine response over initial 28 day and long-term 9-15 month periods. Serum levels of potential liver injury markers are measured, and adverse events recorded.

Results

In an initial study cohort, six subjects received PV-10. Significant adverse events were limited to injection site and photosensitivity reactions, and resolved without sequelae. All injected tumors were stable in size at 28 days, and of 4 that had long-term assessment, 2 had partial response, for a long-term tumor-specific objective response rate of 50%. PV-10 plasma levels decreased rapidly in a bi-exponential pattern, with initial and terminal phase half-lives of 4.5 and 100 hours, respectively. Elevated liver enzymes levels subsided within a week of treatment.

Conclusion

Preliminary efficacy in treatment of liver tumors with PV-10 was observed. Toxicity was transient, and treatment had acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to assess response in hepatocellular carcinoma and other cancers metastatic to the liver.