Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours
Tuesday September 2, 2:01 am ET
CALGARY, Sept. 2 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours. The Principal Investigator is Dr. Miguel Villalona-Calero, Professor Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center.
"In this era of personalized cancer treatment, we are quite excited about this trial," said Dr. Villalona-Calero. "Although we have had for some time treatments that target EGFR, K-RAS has been an elusive target. REOLYSIN® has the potential to target K-RAS activated tumors, possibly enhancing the beneficial effects produced by chemotherapy."
"This trial gives Oncolytics the opportunity to treat NSCLC patients in a first-line clinical setting," said Dr. Brad Thompson, President and CEO of Oncolytics. "Assuming we achieve an acceptable response rate, the combination of REOLYSIN® with paclitaxel and carboplatin for NSCLC would be a strong candidate for registration studies."
This trial is a single arm, two-stage, open-label, Phase 2 study of REOLYSIN® given intravenously with paclitaxel and carboplatin every 3 weeks. Patients will receive four to six cycles of paclitaxel and carboplatin in conjunction with REOLYSIN®, at which time REOLYSIN® may be continued as a monotherapy. It is anticipated that up to 36 patients will be treated in this trial.
Eligible patients include those with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, who have not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in K-RAS or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.
The primary objectives of the Phase 2 trial are to determine the objective response rate of REOLYSIN® in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, and to measure progression-free survival at 6 months. The secondary objectives are to determine the median survival and duration of progression-free survival in patients, and to evaluate the safety and tolerability of REOLYSIN® in combination with paclitaxel and carboplatin in this patient population.
REOLYSIN® preferentially replicates in cancer cells that have an activated RAS pathway. Approximately two thirds of all cancers have an activated RAS pathway, including most metastatic disease. A large number of mutations, including mutations in EGFR, Her2 or K-RAS along the RAS pathway lead to RAS pathway activation.
Recent clinical studies in NSCLC with EGFR-based therapies have shown that patients with mutations or overexpression of EGFR, which are commonly found in NSCLC, derive clinical benefit from these therapies. An agent such as REOLYSIN® that selectively replicates in cancers with an activated RAS pathway resulting from EGFR mutations or overexpression may show similar benefit. However, patients with mutant K-RAS, or up to 20% of the more than 180,000 patients diagnosed every year in the U.S. with NSCLC, do not derive benefit from EGFR-based therapies. The introduction of screening for K-RAS mutations, and the exclusion of K-RAS mutated patients will lead to higher response rates in EGFR-mutated or overexpressed patients treated with EGFR-based therapies. This excluded patient group is therefore prescreened for RAS pathway activation resulting from mutations in K-RAS, and an agent such as REOLYSIN® may be indicated for this patient group. This study targets patients with either EGFR-activated tumours or K-RAS mutations.
"Previous preclinical data indicates that reovirus tends to localize in the lungs, and we have seen clinical responses in metastatic lung lesions with REOLYSIN® as a monotherapy or in combination with paclitaxel and carboplatin," said Dr. Brad Thompson, President and CEO of Oncolytics. "A significant clinical opportunity for REOLYSIN® is in the treatment of patients with metastatic cancers including NSCLC who have a mutated K-RAS gene and are unlikely to respond to treatment with EGF receptor inhibitors."
surf's up......crikey
