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Article

A Phase II Study of Pelareorep (REOLYSIN®) in Combination with Gemcitabine for Patients with Advanced Pancreatic Adenocarcinoma

1
Division of Hematology/Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60611, USA
2
Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, TX 78229, USA
3
Montefiore Medical Center, New York, NY 10467, USA
4
Oncolytics Biotech Inc., Calgary, AB T2N 1X7, Canada
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Department of Medicine, Division of Translational and Regenerative Medicine, University of Arizona Cancer Center, Tucson, AZ 85724, USA
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Comprehensive Cancer Center, Ohio State University, Columbus, OH and Phylogeny, Inc., Powell, OH 43065, USA
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Samuel Oschin Comprehensive Cancer Institute, Los Angeles, CA 90048, USA
*
Author to whom correspondence should be addressed.
Cancers 2018, 10(6), 160; https://doi.org/10.3390/cancers10060160
Received: 20 April 2018 / Revised: 16 May 2018 / Accepted: 17 May 2018 / Published: 25 May 2018
(This article belongs to the Special Issue Oncolytic Virotherapy)
Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with 1 and 5-year survival rates of ~18% and 7% respectively. FOLFIRINOX or gemcitabine in combination with nab-paclitaxel are standard treatment options for metastatic disease. However, both regimens are more toxic than gemcitabine alone. Pelareorep (REOLYSIN®), a proprietary isolate of reovirus Type 3 Dearing, has shown antitumor activity in clinical and preclinical models. In addition to direct cytotoxic effects, pelareorep can trigger antitumor immune responses. Due to the high frequency of RAS mutations in PDAC, we hypothesized that pelareorep would promote selective reovirus replication in pancreatic tumors and enhance the anticancer activity of gemcitabine. Chemotherapy-naïve patients with advanced PDAC were eligible for the study. The primary objective was Clinical Benefit Rate (complete response (CR) + partial response (PR) + stable disease (SD) ≥ 12 weeks) and secondary objectives include overall survival (OS), toxicity, and pharmacodynamics (PD) analysis. The study enrolled 34 patients; results included one partial response, 23 stable disease, and 5 progressive disease. The median OS was 10.2 months, with a 1- and 2-year survival rate of 45% and 24%, respectively. The treatment was well tolerated with manageable nonhematological toxicities. PD analysis revealed reovirus replication within pancreatic tumor and associated apoptosis. Upregulation of immune checkpoint marker PD-L1 suggests future consideration of combining oncolytic virus therapy with anti-PD-L1 inhibitors. We conclude that pelareorep complements single agent gemcitabine in PDAC. View Full-Text
Keywords: REOLYSIN®; pelareorep; reovirus; immuno-oncolytic virus; pancreatic cancer; PD-L1 REOLYSIN®; pelareorep; reovirus; immuno-oncolytic virus; pancreatic cancer; PD-L1
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MDPI and ACS Style

Mahalingam, D.; Goel, S.; Aparo, S.; Patel Arora, S.; Noronha, N.; Tran, H.; Chakrabarty, R.; Selvaggi, G.; Gutierrez, A.; Coffey, M.; Nawrocki, S.T.; Nuovo, G.; Mita, M.M. A Phase II Study of Pelareorep (REOLYSIN®) in Combination with Gemcitabine for Patients with Advanced Pancreatic Adenocarcinoma. Cancers 2018, 10, 160. https://doi.org/10.3390/cancers10060160

AMA Style

Mahalingam D, Goel S, Aparo S, Patel Arora S, Noronha N, Tran H, Chakrabarty R, Selvaggi G, Gutierrez A, Coffey M, Nawrocki ST, Nuovo G, Mita MM. A Phase II Study of Pelareorep (REOLYSIN®) in Combination with Gemcitabine for Patients with Advanced Pancreatic Adenocarcinoma. Cancers. 2018; 10(6):160. https://doi.org/10.3390/cancers10060160

Chicago/Turabian Style

Mahalingam, Devalingam, Sanjay Goel, Santiago Aparo, Sukeshi Patel Arora, Nicole Noronha, Hue Tran, Romit Chakrabarty, Giovanni Selvaggi, Andres Gutierrez, Matthew Coffey, Steffan T. Nawrocki, Gerard Nuovo, and Monica M. Mita. 2018. "A Phase II Study of Pelareorep (REOLYSIN®) in Combination with Gemcitabine for Patients with Advanced Pancreatic Adenocarcinoma" Cancers 10, no. 6: 160. https://doi.org/10.3390/cancers10060160

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