Phase 1 study of Intralesional (IL) rose bengal (PV-10), an investigational autolytic immunotherapy

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Introduction: Intralesional (IL) rose bengal (PV-10) is an investigational autolytic immunotherapy.

Aim(s): This phase 1 study (NCT02693067) evaluated safety, tolerability, and impact on symptoms and biochemical markers following percutaneous injection of PV-10 to hepatic lesions in patients (pts) with symptomatic mNEN progressive after SSA and PRRT.

Materials and methods: Eligible lesions were 1.0–3.9 cm in diameter with amount of IL PV-10 proportional to size. Repeat cycles allowed ≥6 weeks apart. The primary endpoint was safety. Secondary endpoints included objective response rate (ORR) by contrast enhanced CT (RECIST 1.1) and 68Ga-DOTATATE PET; biochemical response (CgA and lymphocytes); and patient-reported outcome (EORTC QLQ-C30 and GI.NET21).

Conference:

Presenting Author:

Authors: Price T, Cehic G, Watcher E, Sebbon R, Neuhaus S,

Keywords: PV-10, immunotherapy, phase 1,