Oncolytics Biotech has announced updated results from a randomized phase 2 study of Reolysin, a proprietary variant of the reovirus, in combination with carboplatin and paclitaxel in patients with metastatic pancreatic cancer. The study was sponsored by the National Cancer Institute (NCI). The new results are based on data collected up to January 19, 2016, from the NCI, and update information from previous disclosures by the principal investigator.
In the open-label, multicenter trial, the patients were randomly assigned to receive either carboplatin, paclitaxel, and Reolysin (the test arm; n = 36) or carboplatin and paclitaxel (the control arm; n = 20). The patients in both arms received treatment every three weeks (21-day cycles) and standard intravenous doses of paclitaxel and carboplatin on day 1 only. In the test arm, the patients also received intravenous Reolysin at a dose of 3x1010 TCID50 on days 1 through 5. The tumor response was assessed every eight weeks by computed tomography scan. Patients who progressed on carboplatin and paclitaxel (the control arm) had Reolysin added (the crossover arm; n = 16). If patients experienced significant toxicity related to carboplatin and/or paclitaxel, they could continue with single-agent Reolysin.
The study’s primary objective was to assess the improvement in progression-free survival with Reolysin, carboplatin, and paclitaxel compared with carboplatin and paclitaxel in patients with metastatic pancreatic cancer. Secondary endpoints included safety, the overall response rate, overall survival (OS), immune factors, and the relationship between Ras mutations in tumor samples and the response to Reolysin. For the latter analysis, the control arm consisted of patients receiving carboplatin and paclitaxel alone; the test arm consisted of patients receiving carboplatin, paclitaxel, and Reolysin; and the crossover arm consisted of patients initially treated with carboplatin and paclitaxel who progressed and subsequently had Reolysin added to their treatment regimen.
Oncolytics Biotech conducted an intention-to-treat analysis of OS in patients with confirmed treatment regimens, as assessed by the percentage of patients surviving for two years. The analysis showed a significantly higher percentage of patients surviving two years in the test arm compared with the control arm (17.7% versus 0%, respectively; P = 0.001); in the crossover arm compared with the control arm (12.5% versus 0%; P = 0.03); and in the combined test and crossover arms compared with the control arm (16.0% versus 0%; P = 0.0004). At the data cut-off date (January 19, 2016), there were five survivors in the test arm and one survivor in the crossover arm.
Source: Oncolytics Biotech; April 14, 2016.