On August 27, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) reported that Dr. Miguel A. Villalona-Calero will make an oral presentation at International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer on September 9, 2015 (Press release, Oncolytics Biotech, AUG 27, 2015, View Source [SID:1234507352]). The presentation, titled "Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covers updated results, including longer-term survival data, from the Company’s REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC).
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"Our research collaborators are noting the two-year survival data from this study, which is high for later-stage patients with recurrent or metastatic disease," said Dr. Matt Coffey, COO of Oncolytics. "As with our REO 017 clinical study that treated pancreatic cancer patients with gemcitabine and REOLYSIN, there was a clear overall survival benefit with apparent limited impact on progression free survival, which is generally characteristic of immune involvement in outcomes."
Highlights of the data to be presented include:
A survival analysis for 37 Stage IV patients showing a median progression free survival (PFS) of four months and median overall survival (OS) of 13.1 months;
One- and two-year survival rates of 57% and 30%, respectively, with the authors concluding that the survival of 11 patients longer than two years was substantial; and
Seven patients remaining alive after a median follow up of 34.2 months (range 26.9-71.5 months), with two patients showing no evidence of disease progression to date (50 and 37 months).
For comparison, the Company is referring to historical control data as per Schiller et al., 2002, which reported a median PFS of 3.1 months, median OS of 8.1 months, one-year survival rates of 34%, and two-year survival rates of 11%. There were 290 patients treated with carboplatin and paclitaxel, 86% of which were Stage IV and 14% Stage IIIB.
Of the 35 patients evaluable for clinical response in the REO 016 study, 11 patients (5 Kras mutant) had a partial response (PR), 20 had stable disease (SD) and four had progressive disease by RECIST for an objective response rate (ORR) of 31%. Four patients with SD had a >40% PET standardized update value reduction after two cycles, yielding an ORR considering PET of 43%.
REO 016 is a U.S. single arm, two-stage, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. Patients received four to six cycles of paclitaxel and carboplatin in conjunction with REOLYSIN, at which time REOLYSIN may have been continued as a monotherapy. As previously disclosed, the primary objectives of the trial were to determine the ORR of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with Kras or EGFR-activated tumours, and to measure PFS at six months. The secondary objectives were to determine the median survival and duration of PFS in patients, and to evaluate the safety and tolerability of REOLYSIN in combination with paclitaxel and carboplatin in this patient population.
A copy of the abstract will be available on the Oncolytics website at: View Source and is also available on the conference website at: View Source