On August 10, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies against difficult-to-treat cancers, reported the final topline results of the DeCidE1 Phase 2 clinical trial evaluating maveropepimut-S (MVP-S, formerly known as DPX-Survivac) in subjects with advanced recurrent ovarian cancer (Press release, IMV, AUG 10, 2021, View Source [SID1234586217]).
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"The overall results obtained from the DeCidE1 trial are very promising," said Dr. Oliver Dorigo, Principal Investigator of the DeCidE1 study and Director of the Gynecologic Oncology Service at Stanford University. "Treatment was well-tolerated with an overall survival rate of 44.9% at 23.8 months of follow up and a median overall survival of 19.9 months. These results are particularly encouraging because many subjects in the trial had been heavily pre-treated and 57.9% were platinum resistant. We believe that these results support the further clinical study of maveropepimut-S in ovarian cancer." Secondary endpoints in the DeCidE1 clinical study included an extensive analysis of collected biological samples. Dr Jeremy Graff, Chief Scientific Officer of IMV commented, "The translational analyses provide strong evidence that maveropepimut-S successfully elicits the generation of tumor antigen-specific T cells. Importantly, these analyses affirm the molecular and cellular mechanism of MVP-S based therapy. This data will also inform the discussion and design of a Phase 2 clinical study to be submitted to the FDA." The details of these translational analyses have been submitted to upcoming scientific meetings for presentation.
About the DeCidE1 Study
"DeCidE1" was a Phase 1b/2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of maveropepimut-S (MVP-S, formerly named DPX-Survivac) with intermittent low dose cyclophosphamide (CPA). This Phase 2 trial enrolled 22 subjects with recurrent, advanced platinum-sensitive and resistant ovarian cancer. Subjects received 2 subcutaneous injections of MVP-S three weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off until end of treatment. Tumor biopsies were performed prior to treatment and on treatment.
Primary endpoints of this study were overall response rate, disease control rate and safety. Secondary endpoints included cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival, and biomarker analyses. More information on the DeCidE1 study can be found here.