IMV Inc IMVIQ

RE:RE:RE:Presentations

[LR6852]

Abstract is now available online:

Background: Maveropepimut-S (MVP-S) is a novel immunotherapeutic that educates a specific CD8 T cell response to the cancer antigen, survivin, to orchestrate immune-mediated elimination of survivin-expressing cancer cells. Specifically, MVP-S is a lipid-in-oil formulation of the DPX delivery platform, incorporating five survivin-specific immunogenic peptides, the innate immune stimulant, polydIdC, and a CD4 T cell helper peptide. In prior clinical studies, MVP-S and intermittent low-dose cyclophosphamide (CPA) elicited confirmed clinical responses (both partial and complete by RECISTv1.1) and induced a robust, durable survivin-specific CD8 T cell response. Moreover, the combination with pembrolizumab appeared to be well tolerated in solid tumors and lymphomas. The purpose of this phase 2 study is to explore whether this combination may be safe and effective in advanced, metastatic bladder cancer patients, both nave to, and previously treated with, immune checkpoint inhibitors.
Results: Seventeen (17) subjects were treated with the combination of MVP-S, CPA and pembrolizumab. Subjects received an average of 3 prior lines of therapy with 13/17 (76.4%) having previously received an anti-PD1/L1. Seven subjects progressed on or after anti-PD1/L1 as last line of therapy prior to entering the trial. The combination was well-tolerated, with majority of AEs being grade 1 or grade 2. Five (5) out of 17 subjects showed response: 3 subjects with PR (unconfirmed) and 2 with CR (confirmed). Three of these, including the 2 CRs, had progressed on anti-PD-1/L1. Long-term clinical benefit has been observed in several subjects (one patient is still on treatment after 17 months) and coincides with an increase in detectable survivin-specific T cells in peripheral blood.
Conclusion: Preliminary data suggest that MVP-S/CPA and pembrolizumab is a well-tolerated combination and shows encouraging preliminary clinical activity in the treatment of advanced or metastatic bladder cancer patients, including patients who have progressed on prior anti-PD-1/L1 therapy.