Oncolytics Biotech (ONCY) REOLYSIN w/ REO 020 Met Primary Endpoint in Phase 2
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Oncolytics Biotech, Inc. (Nasdaq: ONCY) 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.
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.
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