IMV Inc. Presents Positive Initial Results From The MVP-S Phase 2B VITALIZE Trial
IMV Inc. has announced positive preliminary data from the VITALIZE Phase 2B trial of its lead product, maveropepimut-S (MVP-S), combined with pembrolizumab for treating relapsed, refractory Diffuse Large B Cell Lymphoma (r/r DLBCL). Among 6 evaluable patients, 3 achieved confirmed complete responses, with no adverse safety signals reported. The trial aims to recruit up to 102 patients, assessing the treatment's efficacy. CEO Andrew Hall highlighted the significance of these results, especially given the challenging patient population. The Overall Response Rate (ORR) will be reported later when all data is available.
- 3 out of 6 evaluable patients showed confirmed complete responses in the VITALIZE trial.
- No adverse safety signals reported, consistent with prior trials.
- Encouraging trends noted in the treatment's efficacy.
- 2 patients with poor baseline functionality did not complete the study.
Early analysis reveals clinically meaningful activity in refractory DLBCL patients
Multiple confirmed complete responses observed in heavily pre-treated patients
No adverse safety and tolerability signal reported, consistent with previous clinical trials
Key initial findings from the ongoing VITALIZE trial:
- 8 Patients with an ECOG1 score of 0-1 have been enrolled in arm 1 of the study. Of these, 6 have so far been evaluable for efficacy;
- Of these 6 evaluable patients, 3 patients showed confirmed complete responses, 1 patient was assessed with stable disease as best response and 2 patients were assessed with progressive disease as best response; and
- 2 patients with poor level of baseline functionality (ECOG ≥ 2) failed to stay on study through to the first scan and therefore could not be evaluated.
Overall Response Rate (“ORR”) will be communicated when the totality of stage one data are available for definitive assessment.
“VITALIZE is our most advanced and rigorous trial to date, and we are encouraged by the way the data for MVP-S are trending. This is the most refractory population of patients we have treated so far, and to show complete, confirmed clinical responses is notable. These positive initial results, combined with the accelerating recruitment of the AVALON study in platinum resistant ovarian cancer add, we believe, to the growing industry enthusiasm about the potential for MVP-S in multiple tumor settings,” said
About the VITALIZE Study
The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess IMV’s lead candidate, MVP-S, in combination with pembrolizumab with (arm 1) or without (arm 2) cyclophosphamide. Across the arms of this study, the combination will be evaluated in up to 30 patients in stage one (two arms of 15) with the option to expand to up to a total of 102 subjects in stage two with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.
About the AVALON study
The AVALON study is an open label, company-sponsored phase 2b, single arm trial evaluating the efficacy and safety of MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with platinum-resistant ovarian cancer. The study is a Simon two-stage design where up to 41 subjects will be evaluated in stage one, with the option to expand to up to a total of 73 patients in stage two. Patients participating in the trial will receive two doses of subcutaneous MVP-S once every three weeks, followed by an MVP-S dose once every eight weeks, plus low-dose oral CPA on a repeating cycle of one week on/one week off.
About IMV
IMV Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this press release, such forward-looking statements include, but are not limited to, statements regarding the potential and efficacy of MVP-S, the potential impact of the VITALIZE study and timing of availability of the ORR from the remaining stage one patients from its Phase 2B trial, the Company’s ability to advance its development strategy, and the prospects for its lead immunotherapy and its other pipeline of immunotherapy candidates.
1 ECOG is a measure of patient functionality and is measured according to a standardized measure ranging from 0-5. Oken et al., Toxicity and response criteria of the
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Investor Relations & Media
Delphine Davan
Senior Director, Communications and Investor Relations
O: (902) 492.1819 ext: 1049
E: ddavan@imv-inc.com
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