Updated Clinical Data from Phase 2 SPiReL Study Evaluating DPX-Survivac as a Combination Therapy in r/r DLBCL Presented at 61st American Society of Hematology (ASH) Annual Meeting
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced that updated results from SPiReL, an ongoing Phase 2 investigator-sponsored study of DPX-Survivac in combination with pembrolizumab in patients with recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL), were presented in a poster session at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, FL. The poster, which included additional data collected between the abstract submission and the presentation, continued to demonstrate a favorable therapeutic profile and treatment-associated clinical benefit in r/r DLBCL patients who received the DPX-Survivac combination regimen.
“These updated data show encouraging clinical activity in patients treated with a DPX-Survivac combination regimen for recurrent/refractory diffuse large B-cell lymphoma,” said Neil Berinstein, MD, FFCPC, ABIM, hematologist at Sunnybrook Health Sciences Centre and lead investigator for the clinical trial. “In contrast, both to standard-of-care treatments and other immunotherapeutic approaches in development, to observe this clinical benefit alongside a favorable safety profile highlights DPX-Survivac’s potential to reach this patient population in dire need of better treatment options.”
“These results demonstrate a robust response in evaluable patients who received the combination regimen including DPX-Survivac, which continues to exhibit a promising therapeutic profile for patients with hard-to-treat cancers,” said Joanne Schindler, M.D., D.V.M., Chief Medical Officer of IMV. “These data further validate DPX-Survivac’s novel mechanism, extending previously documented results in solid cancers now to survivin-expressing hematologic malignancies, and support the hypothesis that our lead candidate works well in combination with checkpoint inhibitors. We believe this represents a potentially meaningful alternative to more toxic chemotherapy regimens; and, with this foundation, we look forward to topline results from this study as we prepare to launch an IMV-sponsored study in r/r DLBCL in 2020.”
Updated Clinical Data from the SPiReL Study
In the poster presentation at ASH, Dr. Berinstein reported updated clinical results from the ongoing Phase 2 SPiReL study. Highlights of this preliminary data are outlined below:
- 7/9 (77.8%) evaluable subjects exhibited clinical benefit, including three (33.3%) complete responses and two (22.2%) partial responses;
- Reproducible survivin-specific T cell responses observed in all subjects that achieved clinical responses on treatment;
- One subject, who received three prior lines of systemic therapies and failed autologous stem cell transplant, reached a complete response at the first on-study scan following treatment with the DPX-Survivac combination regimen and remains free of disease recurrence after completing the study; and
- Clinical benefits and favorable toxicity profile observed in a heterogenous population of r/r DLBCL patients, including patients of advanced age and/or with comorbidities, who are more susceptible to adverse effects and more difficult to treat.
As of December 1, 2019, 17 subjects have been enrolled in the study.