title: A phase II study of REOLYSIN®(pelareorep) in combination with carboplatin and paclitaxel for patients with advanced malignant melanoma.
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.
authors.affiliation: Division of Hematology/Oncology, Cancer Therapy and Research Center, University of Texas Health Science Center, 7979 Wurzbach Rd, San Antonio, TX, 78229, USA. Mahalingam@uthscsa.edu.|Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio, San Antonio, TX, USA. Mahalingam@uthscsa.edu.
authors.forename: Devalingam
authors.initials: D
authors.lastname: Mahalingam
authors.affiliation: Division of Hematology/Oncology, Cancer Therapy and Research Center, University of Texas Health Science Center, 7979 Wurzbach Rd, San Antonio, TX, 78229, USA.
authors.forename: Christos
authors.initials: C
authors.lastname: Fountzilas
authors.affiliation: Division of Hematology/Oncology, Cancer Therapy and Research Center, University of Texas Health Science Center, 7979 Wurzbach Rd, San Antonio, TX, 78229, USA.|Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Moseley
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Nicole
authors.initials: N
authors.lastname: Noronha
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Hue
authors.initials: H
authors.lastname: Tran
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Romit
authors.initials: R
authors.lastname: Chakrabarty
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Selvaggi
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Matthew
authors.initials: M
authors.lastname: Coffey
authors.affiliation: Oncolytics Biotech Inc., 210, 1167 Kensington Cr. NW, Calgary, AB, Canada.
authors.forename: Brad
authors.initials: B
authors.lastname: Thompson
authors.affiliation: Division of Hematology/Oncology, Cancer Therapy and Research Center, University of Texas Health Science Center, 7979 Wurzbach Rd, San Antonio, TX, 78229, USA.|Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center San Antonio, San Antonio, TX, USA.
authors.forename: John
authors.initials: J
authors.lastname: Sarantopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D012089:Mammalian orthoreovirus 3; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D050130:Oncolytic Virotherapy; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel
keywords: Melanoma; Oncolytic virus; Pelareorep; REOLYSIN®; Reovirus