Oncolytics Biotech Inc., a biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, has completed patient enrollment in a phase II clinical trial evaluating intravenous administration of Reolysin in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours (REO 016).

This trial is a single arm, single-stage, open-label, phase II study of Reolysin given intravenously with paclitaxel and carboplatin every three weeks. Patients received four to six cycles of paclitaxel and carboplatin in conjunction with Reolysin, following which Reolysin could be continued as a monotherapy.

Eligible patients included those with metastatic or recurrent NSCLC with Kras or EGFR-activated tumours, who had not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in Kras or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.

The Company previously reported in November 2012 that 33 patients had received Reovirus (Reolysin) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response evaluation data reported among 30 evaluable patients showed 27 patients had stable disease or better for a 90 per cent clinical benefit rate (nine partial response (PR) (30 per cent) and 18 stable disease (SD) (60 per cent)). Three patients had progressive disease (PD) as their best response.

"We have seen encouraging results in both this and other trials looking at primary and metastatic lung disease and are continuing to push our lung program forward on that basis," said Dr Brad Thompson, president and CEO of Oncolytics. "We have extended our work in this indication beyond this drug combination and are currently evaluating Reolysin in conjunction with docetaxel or pemetrexed in a second line open-label, randomized, non-blinded, phase II clinical study sponsored by the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario that will enroll up to 150 squamous cell and adenocarcinoma of the lung patients."