Oncolytics Biotech Inc. (ONCY)

[onco_investor]

Pancreatic Gemc Combo Abstract Released at AACR

http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=dbdc0b09-936f-4d6a-9c0a-756e0cd55f51&cKey=e39c6e23-bc11-43d2-8d42-e12eef71f226&mKey=%7bA57FF86D-D414-4079-BCBD-157746574F37%7d


Abstract Number: B55

Presentation Title:
A Study of REOLYSIN in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma

Location: West Hall, Level One, Moscone Center West

Poster Board Number: B55

Author Block:
Monica M. Mita1, Yubao Wang2, John Sarantopoulos1, Sushma Vemulapalli1, Benjamin George3, Alain Mita1, Mattew Coffey4, George Gill5, Devaligam Mahaligam1. 1Cancer Therapy and Research Center at UTHSCSA, San Antonio, TX; 2Cancer Therapy and Reserach Center, San Antonio, TX; 3Brooke Army Medical Center, San Antonio, TX; 4Oncolytics Biothech, Calgary, AB, Canada; 5Oncolytics Biotech, Calgary, AB, Canada

Abstract Body: Background: Pancreatic cancer (Pca) continues to have a dismal prognosis and very little progress has been made in finding new efficacious treatments. Oncolytic viruses have demonstrated cytotoxic effect in several tumor xenografts, particularly in cells with RAS pathway activation. REOLYSIN (Reovirus serotype 3) has shown extensive antitumor activity in preclinical models, as well as synergistic activity with cytotoxics including gemcitabine in various cancers. Several phase 1 and 2 clinical trials demonstrated tolerability and promising activity of REOLYSIN administered as a single agent in patients with solid tumors. Due to the high frequency of Kras pathway activation in Pca, we hypothesized that REOLYSIN may enhance the anticancer activity of chemotherapy in this tumor type. Therefore, this study was initiated to test the safety and efficacy of a combination of REOLYSIN with gemcitabine in previously untreated patients with Pca.

Methods: Patients with diagnosis of chemotherapy-naïve, surgically unresectable or metastatic Pca are eligible for the study. The primary objective is Clinical Benefit Rate (CBR=CR+PR+SD>12 weeks).

Secondary objectives include progression-free survival (PFS), toxicity, tolerability as well as pharmacokinetics (PK) and pharmacodynamics (PD). Patients are treated with gemcitabine at 800 mg/m2 day 1 and 8, and REOLYSIN administered IV at day 1, 2 and 8, 9. Tumor assessment is performed every 2 cycles (6 weeks). A two stage design is used for this study. In stage 1 at least 3/17 patients must achieve CBR in order to proceed to stage 2.

Results: Fourteen patients were enrolled in the study and 10 are evaluable for efficacy. Age ranged from 48 to 82 years, mean 67 years. All patients except one reported symptomatic improvement. No CR were reported.

Two patients have SD for =36 weeks and one patient continues on study with SD at 39 weeks.

An additional patient had an unconfirmed PR of less than 6 weeks.

Six patients had SD = 12 weeks.

The treatment was well tolerated with common non-hematological toxicities including grade 1 fever, chills, nausea and vomiting. Only two patients had grade 3 neutropenia lasting 1-2 days. No other grade 3 toxicities were seen.

Conclusion: The endpoint for the first stage of the study (=3 CBR in the first 17 patients) has been reached and therefore enrollment will continue. REOLYSIN in combination with gemcitabine has demonstrated clinical benefit in patients with unresectable Pca with a tolerable toxicity profile.