Percutaneous hepatic injection of rose bengal disodium (PV-10) in metastatic uveal melanoma.

作者：Sapna P. Patel, Brett W. Carter, Ravi Murthy, Rahul A. Sheth, Sanjiv S. Agarwala, Gary Lu, Ellen Redstone, Gener Balmes, Helene Rider, Dominic Rodrigues, Eric A. Wachter · 发表于：Journal of Clinical Oncology · 年份：2020 · DOI：10.1200/jco.2020.38.15_suppl.3143 · 被引用次数：8 · 研究领域：Ocular Oncology and Treatments、Corneal Surgery and Treatments、Nanoplatforms for cancer theranostics

3143 Background: PV-10 is a small molecule autolytic immunotherapy in clinical development for treatment of solid tumors. When administered by intralesional (IL) injection, PV-10 can produce immunogenic cell death that may induce a T cell-mediated immune response against treatment refractory and immunologically cold tumors. Given this mechanism of action and clinical data that metastatic uveal melanoma (MUM) generates low response rates to immune checkpoint blockade (CB), we investigated treatment of MUM with percutaneously-delivered PV-10. Methods: This open-label Phase 1 basket study (NCT00986661) is evaluating the safety, tolerability, and preliminary efficacy of intralesional PV-10 in patients (pts) with solid tumors of the liver. PV-10 is injected into one or more designated hepatic tumor(s) with a maximum sum of diameters ≤4.9 cm. Response assessments using 2D EASL criteria are performed at Day 28, then every 3 months. Pts with additional injectable tumors are eligible to receive further PV-10 after Day 28. Pts can receive standard of care CB immunotherapy during treatment with PV-10. Results: As of February 1, 2020, the initial cohort of 15 pts with MUM to the liver was fully enrolled. Pts had received at least 1 IL injection of PV-10, with an average of 2 hepatic lesions injected per pt (range 1-4). Of these, 4 pts were refractory to prior CB. Three pts received PV-10 alone, 3 received PV-10 + anti-PD-1 and 9 received PV-10 + anti-PD-1 + anti-CTLA-4. Adverse events (A...