Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Platinum-Refractory Head and Neck Cancers
REO 018 is a randomized, double-blind, two-arm, multi-centre trial assessing the intravenous administration of REOLYSIN® with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. The trial enrolled a total of 167 patients segregated into two patient groups: patients with local recurrent disease, with or without distal metastases, and those with only distal metastases. All patients received treatment every three weeks (21-day cycles) with paclitaxel and carboplatin and also received, on a blinded basis, either intravenous placebo or intravenous REOLYSIN®. All dosing took place in the first five days of each cycle with all patients receiving standard intravenous doses of paclitaxel and carboplatin on Day one only, and either intravenous placebo or intravenous REOLYSIN® at a dose of 3x1010 TCID50 on Days 1-5.
In December 2012, Oncolytics announced positive top-line data on an endpoint examining initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study. Of the 105 total patients with evaluable metastatic tumours, 86 percent (n=50) of those in the test arm of the study exhibited tumour stabilization (defined as zero percent growth only) or shrinkage, compared with 67 percent of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025. The analysis also showed that REOLYSIN® in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumours, yielding a p-value of 0.03.
In November 2013 Oncolytics announced positive top-line data from an intent-to-treat analysis of the 118 patients in the study with loco-regional head and neck cancer, with or without metastases. Median progression-free survival (PFS) for this group of patients was 94 days (13.4 weeks) in the test arm (n=62), versus 50 days (7.1 weeks) in the control arm (n=56). Patients who received REOLYSIN® had increased benefit through five cycles of therapy. Eighty-eight of the loco-regional patients did not receive additional therapy following discontinuation of study treatment; median overall survival (OS) for this group of patients was 150 days (21.4 weeks) in the test arm (n=50), versus 115 days (16.4 weeks) in the control arm (n=38). At the time of reporting, there had not been a sufficient number of data events to conduct a survival analysis of patients in the metastatic-only group (i.e. those patients with no loco-regional recurrence). An analysis performed at the same time of all 167 patients enrolled in the study found REOLYSIN® to be safe and well-tolerated by patients. Patients on the test arm of the study experienced a higher incidence of flu-like symptoms consistent with those noted in earlier clinical studies of REOLYSIN® and treatment with a virus, most commonly mild fever, chills, nausea and diarrhea. Fewer patients required dose reductions of paclitaxel due to neuropathy or neurotoxicity on the test arm than the control arm (zero in the test arm versus six in the control arm; p=0.028); on this basis, the Company intends to explore the potential chemoprotective and neuroprotective properties of REOLYSIN® in future clinical studies.
Oncolytics intends to treat the REO 018 clinical trial as a separate supportive study to a planned randomized, follow-on international Phase III registration study of REOLYSIN® in patients with loco-regional head and neck cancer.
- November 21, 2013: Oncolytics Biotech Inc Announces Positive Top-Line Data from REO 018 Randomized Study of REOLYSIN® in Head and Neck Cancers (Press Release)
- December 13, 2012: Oncolytics Biotech Inc. Announces Positive Top Line REOLYSIN® Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers
- June 20, 2012: Oncolytics Announces Independent Data Monitoring Committee Recommends Continued Enrollment in Phase III Study of REOLYSIN® in Head and Neck Cancers Following Review of Safety Data
- April 2, 2012: Oncolytics Biotech Completes Enrollment in First Stage of Phase III Study in Head and Neck Cancers (Press Release)