Pooled data analysis of the safety and tolerability of intravenous pelareorep in combination with chemotherapy in 500 + cancer patients

Abstract

Demographics 547 patients; median age (59-62 y) and ECOG 0-1 status (90-97%) similar across the groups (Table 1). Studies with P±R included female patients only (except for 1 male), whereas male patients were the majority in the studies with CPR or CP (68-72%). All patients in P or PR had received prior chemo but only 26% in CP and 40% in CPR. Table 1. Demographics Data (Safety Population) Serious TEAEs considered to be treatment-related by the Investigator are presented in Table 3. Fever, nausea, and vomiting were the only events reported in >1 patient.

Combinatorial Approaches for Cancer Treatment Using Oncolytic Viruses: Projecting the Perspectives through Clinical Trials Outcomes

“…Reoviruses demonstrated Grade 1–2 toxicity (flu-like symptoms) with sporadic 3–4 grade toxicity (neutropenia, respiratory failure). Pooled data analysis of the safety and tolerability of pelareorep from eight clinical trials are summarized by Gutierrez et al [ 202 ]. Despite the long period of reovirus research, only one clinical trial has advanced to Phase III clinical trial testing efficacy of pelareorep in combination with chemotherapy in platinum-refractory head and neck cancers (NCT01166542).…”

“…Encouragingly, most of the studies we reviewed report the safety of virotherapy (Grade 1–2) with only a few cases of severe adverse effects (Grade 3–4). Oncolytics are well-tolerated in various settings and cancer types [ 202 ]. An additional concern is the fact that viral infections may aggravate autoimmune conditions.…”