EDMONTON, AB- OncoQuest Inc. reports positive interim results from its Phase 2b clinical study on its lead product, oregovomab, in patients with advanced epithelial ovarian, adnexal or peritoneal carcinoma (QPT-ORE-002).
The study is being conducted at 13 centers in Italy and the U.S., and is a randomized controlled study to compare the effectiveness of first-line chemotherapy (carboplatin and paclitaxel) versus chemoimmunotherapy (carboplatin-paclitaxel and oregovomab) in this patient population according to an optimized schedule of vaccination identified in a prior Phase 2 study assessing the schedule of these combinations.
A total of 97 patients with newly diagnosed metastatic advanced stage ovarian cancer were enrolled in the study, with 95 patients available for safety assessment. Efficacy analysis showed statistically significant differences in time to clinical relapse, recurrence-free survival and overall survival between patients in the chemo-immunotherapy combination arm versus the arm where patients were solely treated with chemotherapy.
The safety analysis carried out in 95 patients showed no significant difference on the incidents of adverse events, related adverse events and serious adverse events between the two groups.
The study may provide a definitive path for a front line application of oregovomab in ovarian cancer, however, clinical data from long term follow up will require additional time. Professor’s Roberto Angioli and Giovani Scambia are co-principal Investigators for the study and results are expected to be presented at an upcoming cancer conference.
OncoQuest’s proprietary approach involves combinatorial immunotherapy which is intended to take advantage of immune modulating effects of selected cytotoxic agents normally used as part of standard chemotherapy regimens, as well as the use of specific immune adjuvants. It is hypothesized that this schedule dependent combination can modify the attenuated immune regulatory environment while activating specific cellular immunity and making tumors more susceptible to cellular immune pathways. OncoQuest will continue to follow the patients until the end of the long term follow up period, and is also assessing the immunologic data collected from the patients.