Reference Detail

Ref Type

Journal Article

PMID

(29799479)

Authors

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

Title

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

Journal	Vol	Issue	Date	Pages	Journal Short Title
Cancers	10	6	2018 May 25		Cancers (Basel)

URL

Abstract Text

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.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
Pelareorep	Pelareorep	0	4
Pelareorep + Pembrolizumab	Pelareorep Pembrolizumab	0	1

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Pelareorep		REOLYSIN	RAS Inhibitor (Pan) 10	Reolysin (Pelareorep) is a reovirus, which specifically infects and replicates in RAS-activated cells to induce apoptosis, and may also induce anti-tumor immune response (PMID: 29799479).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References