Oncolytics Biotech Inc. announced that a presentation covering interim preliminary results from a phase II clinical trial using 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 was made at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. The conference is being held in Amsterdam, the Netherlands from July 3rd – 7th 2011.
The presentation, entitled “Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic NSCLC who have Kras or EGFR-activated tumours,” was given by Dr Miguel Villalona-Calero, principal investigator for the study, and indicated that 22 patients had received Reovirus (Reolysin) (3 x 10^10 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Initial doses used were carboplatin AUC 6 on day one, and palitaxel 200 mg/m2, on day one of each 21-day cycle. Due to exacerbation of prior gastrointestinal conditions and febrile neutropenia (one each) in the first two patients, doses were reduced to paclitaxel 175 mg/m2 and carboplatin AUC 5.
To date the study has enrolled patients with Adenocarcinoma (15), Squamous Cell Carcinoma (three), Bronchioloalveolar Carcinoma (one), and not otherwise specified non-small cell lung cancer (three). Molecular tumor demographics included: nine Kras mutant, three EGFR mutant, 16 EGFR amplified. Response evaluation to date in 21 patients showed six partial responses (PR) (28.6%), 13 stable disease (SD) (61.9%), two progressive disease (PD) (9.5%). This translates into a clinical benefit rate (complete response (CR)+PR+SD) of 90.5% and a response rate (CR+PR) of 28.6%. The investigators noted that the clinical benefit noted so far is encouraging and that a follow up randomized clinical trial appears warranted.
“The patient response and clinical benefit rates observed in this trial are very encouraging. We will decide which lung cancer indication will proceed into a randomized clinical study based on this data and the data we expect from our ongoing Phase II trial in squamous cell carcinoma lung cancer,” said Dr Brad Thompson, president and CEO of Oncolytics.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a phase III trial in head and neck cancers using Reolysin, its proprietary formulation of the human reovirus.