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Clinical Trial
. 2017 Apr;79(4):697-703.
doi: 10.1007/s00280-017-3260-6. Epub 2017 Mar 13.

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

Devalingam Mahalingam  1   2 , Christos Fountzilas  3 , Jennifer Moseley  3   4 , Nicole Noronha  5 , Hue Tran  5 , Romit Chakrabarty  5 , Giovanni Selvaggi  5 , Matthew Coffey  5 , Brad Thompson  5 , John Sarantopoulos  3   4
Affiliations
Clinical Trial

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

Devalingam Mahalingam et al. Cancer Chemother Pharmacol. 2017 Apr.

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.

Keywords: Melanoma; Oncolytic virus; Pelareorep; REOLYSIN®; Reovirus.

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