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Biothera NSCLC Treatment Hits Primary Endpoint

IIb trial shows efficacy of combination treatment, with survival benefit

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Biothera has posted top-line results from its Phase IIb clinical trial in non-small cell lung cancer (NSCLC) that evaluated its immunotherapeutic drug candidate, Imprime PGG, with cetuximab (Erbitux), carboplatin and paclitaxel compared with the monoclonal antibody and chemotherapy combination alone. Full data will be released at an upcoming scientific meeting.

The primary endpoint of the open label, multicenter, randomized trial in 90 patients with untreated advanced NSCLC was objective response rate. The combination of treatments showed substantial and statistically significant improvement in objective response rate compared to the control group. All adverse events were consistent with toxicities attributable to the cytotoxic drugs or cetuximab.

The study’s objective response rate was improved further in the subset of subjects who tested positive for a biomarker linked to the ability of their immune cells to bind and respond to Imprime PGG. More importantly, a secondary endpoint of overall survival showed dramatic improvement in the magnitude and duration of response among biomarker-positive subjects.

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