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01-04-2017 | Original Article

A phase II study of REOLYSIN^® (pelareorep) in combination with carboplatin and paclitaxel for patients with advanced malignant melanoma

Authors: Devalingam Mahalingam, Christos Fountzilas, Jennifer Moseley, Nicole Noronha, Hue Tran, Romit Chakrabarty, Giovanni Selvaggi, Matthew Coffey, Brad Thompson, John Sarantopoulos

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2017

Abstract

REOLYSIN^® (pelareorep) is an investigational new drug, consisting of a live, replication-competent, Reovirus Type 3 Dearing strain in a proprietary formulation. Several preclinical and clinical trials with REOLYSIN^® on a wide range of cancer indications have demonstrated antineoplastic activity on cells with activated RAS-signaling pathway. Furthermore, long-term survival benefits were evident in post-treatment patients indicating a potential antitumor immune response triggered by REOLYSIN^®. Numerous mono and/or combination therapy studies with the agent showed a consistent safety profile. The current study is a phase II, single-arm, open label trial of REOLYSIN^® in combination with carboplatin and paclitaxel for patients with advanced melanoma. Results from the 14 patients enrolled in the study exhibited no grade 4 adverse events or deaths but manageable grade-3 toxicities commonly attributed to REOLYSIN^®, including pyrexia, chills, myalgia, pain, fatigue, and nausea. The number of treatment cycles ranged from 2 to 20 with a median of 6 cycles. The study met its treatment and efficacy goal for the first stage with three partial responses (ORR was 21%). No complete responses were noted. The median PFS and OS were 5.2 and 10.9 months, respectively. The 1-year OS was 43% with a disease control rate of 85%. In conclusion, REOLYSIN^® combined with carboplatin and paclitaxel is a safe and potentially efficacious therapy for patients with advanced malignant melanoma. Additional combination studies using REOLYSIN^® with chemo/immunotherapy drugs may support more favorable outcomes for patients in this indication.

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Title: A phase II study of REOLYSIN® (pelareorep) in combination with carboplatin and paclitaxel for patients with advanced malignant melanoma
Authors: Devalingam Mahalingam
Christos Fountzilas
Jennifer Moseley
Nicole Noronha
Hue Tran
Romit Chakrabarty
Giovanni Selvaggi
Matthew Coffey
Brad Thompson
John Sarantopoulos
Publication date: 01-04-2017
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 4/2017
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-017-3260-6

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