- Following the feedback from the FDA, IMV (NASDAQ:IMV -2.2%) in agreement with Merck (NYSE:MRK +0.4%) is set to evaluate maveropepimut-S (DPX-Survivac) in combination with Keytruda in recurrent/refractory diffuse large B cell lymphoma (r/rDLBCL).
- Maveropepimut-S, an experimental immunotherapy, is IMV’s lead candidate and Keytruda is an FDA approved anti-PD-1 therapy from Merck.
- The randomized two-stage trial involving 150 subjects will comprise three-arms. Maveropepimut-S and Keytruda combination will be evaluated with or without cyclophosphamide (“CPA”) to test the latter’s effect as an activator of the immune response.
- A third arm will assess maveropepimut-S as a single agent. The primary objective of the trial is Objective Response Rate (“ORR”).
- With Q4 2020 financial results, IMV announced it was finalizing the protocol of the Phase 2b clinical study after receiving feedback from the FDA.