Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Advanced Head and Neck Cancers

 
In 2009, Oncolytics announced positive results in the Phase II component of its Phase I/II UK trial using intravenous administration of REOLYSIN^® in combination with paclitaxel and carboplatin. REOLYSIN^® was well tolerated when administered intravenously in combination with paclitaxel and carboplatin. Of nineteen evaluable patients with head and neck cancer, mostly squamous cell carcinoma (SCCHN) refractory to prior platinum-based chemotherapy for recurrent, metastatic disease, eight experienced partial responses and six had stable disease. The total clinical benefit rate (complete response + partial response + stable disease) of 74% was observed in head and neck cancer patients in the trial.
 
The primary objective of the trial was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN^® when administered in combination with paclitaxel and carboplatin. Secondary objectives included the evaluation of immune response to the drug combination, the body's response to the drug combination compared to chemotherapy alone and any evidence of antitumor activity.
 
An independent, confirmatory Phase II trial (REO 015) using the same combination of REOLYSIN^® and carboplatin/paclitaxel for patients with head and neck cancers is currently underway in the United States. Interim results from both the UK and the US studies formed the basis for the Company’s decision to conduct a Phase III trial (REO 018) looking at REOLYSIN^® in combination with carboplatin/paclitaxel in this patient population. The Company has reached an agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of the Phase III trial.
 
Links:

• August 16, 2012: Synergistic Cytotoxicity of Oncolyic Reovirus in Combination with Cisplatin-paclitaxel Doublet Chemotherapy (PDF)

   

• June 7, 2010: Oncolytics Biotech Inc. Collaborators Present Positive Updated UK Phase I/II Trial Results in Advanced Solid Cancers with a Focus on the Head and Neck at the ASCO Annual Meeting (PDF)

• November 17, 2009: Oncolytics Biotech Inc. Collaborators Present Positive Phase I/II Trial Results in Advanced Solid Cancers with a Focus on the Head and Neck at the AACR-NCI-EORTC Meeting (Press Release)

• November 17, 2009: Phase I/II Trial of Oncolytic Reovirus (REOLYSIN^®) in Combination with Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers with Emphasis on Squamous Cell Carcinoma of the Head and Neck (SCCHN) (PDF)

• July 2, 2009: Oncolytics Biotech Inc. Completes Patient Enrollment in UK Combination REOLYSIN^® and Paclitaxel/Carboplatin Head and Neck Cancer Trial (Press Release)

• March 20, 2009: Oncolytics Biotech Inc. Collaborators Present Positive Head and Neck Results in Phase I/II Combination REOLYSIN^® and Paclitaxel/Carboplatin Trial (Press Release)

• November 3, 2008: Interim Results in Phase I/II Trial of Oncolytic Reovirus (REOLYSIN^®) in Combination with Carboplatin/Paclitaxel in Patients with Advanced Solid Cancers (PDF)