Oncolytics Meets Primary Endpoint for First Stage of U.S. Phase 2 Metastatic Melanoma Trial
News May 27, 2013
Oncolytics Biotech Inc. has announced preliminary results from its U.S. Phase 2 clinical trial in patients with metastatic melanoma using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel (REO 020).
The Principal Investigator is Dr. Devalingam Mahalingam, M.D., Ph.D., MRCP(UK), MRCP(I), clinical investigator in GI/thoracic oncology and drug development at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC).
Eligible patients include those with metastatic malignant melanoma who have failed one or more prior therapies or those not considered a candidate for standard first line therapy.
The primary objective of the Phase 2 trial is to assess the antitumour effect of the treatment regimen in the study population in terms of objective response rates.
The secondary objectives are to assess progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus partial response (PR) plus stable disease (SD)) and duration, and to assess the safety and tolerability of the treatment regimen in the study population.
The study is a two stage design. Up to 18 evaluable patients with metastatic melanoma were to be treated in the first stage.
If three or more patients demonstrated a PR or better, the study could then proceed to the second stage, with up to 43 patients being treated in the entire study.
This endpoint was met after 14 evaluable patients were enrolled. Three of 14 patients exhibited a PR, and an additional seven patients had SD for a disease control rate of 71.5%.
Past research has indicated that human melanoma cell lines were highly permissive to reovirus type 3 Dearing in in vitro experiments, and that intravenous administration of the virus as a monotherapy resulted in significant tumour growth retardation.
A subsequent Phase 2 monotherapy intravenous administration clinical study demonstrated viral replication in biopsy samples of patients.
A Phase 1 all comers intravenous administration clinical study in combination with docetaxel demonstrated partial response and stable disease outcomes in a small (four) melanoma patient subpopulation.
"These preliminary results are very encouraging and support progressing to subsequent studies," said Dr. Brad Thompson, President and CEO of Oncolytics.
Dr. Thompson continued, "Past clinical research has shown that REOLYSIN delivered intravenously replicates in melanoma tumours, and this is the second clinical study to demonstrate responses in patients with REOLYSIN in combination with other therapeutics."
The emergence of genotyping and increasingly targeted therapies is changing how cancer is treated. As a result of recent and potential additional near-term changes to the standard of care for the treatment of melanoma which include agents targeting B-Raf and PD-1, Oncolytics is now conducting research to evaluate REOLYSIN in combination with other emerging treatments for a number of patient sub-populations.
The Company intends to continue with a follow on clinical study in melanoma once this research is concluded. On that basis, the second stage of this clinical trial will not proceed at this time.