Biopharmaceutical firm IMV has reported positive initial data from the Phase IIB VITALIZE trial of maveropepimut-S (MVP-S) along with pembrolizumab in relapsed, refractory Diffuse Large B Cell Lymphoma (r/r DLBCL) patients.
The parallel group, randomised, Simon two-stage Phase IIB trial has been designed for evaluating MVP-S along with pembrolizumab with (arm 1), or without (arm 2), cyclophosphamide.
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This combination will be assessed in up to 30 participants in stage one across the study arms.
The trial also has the option to expand to up to 102 stage two r/r DLBCL patients who have previously received a minimum of two lines of systemic therapy, and people ineligible for or who have failed autologous stem cell transplant (ASCT) therapy.
Preliminary analysis showed clinically meaningful activity in refractory DLBCL patients.
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Initial findings showed that six of the eight participants with a 0-1 ECOG score enrolled in arm 1 of the trial have been evaluable for efficacy.
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By GlobalDataThree of these six patients demonstrated confirmed complete responses, two of them were evaluated with progressive disease as best response, and one patient with stable disease as best response.
The company stated that no adverse safety and tolerability signals were reported in the trial.
IMV CEO Andrew Hall said: “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 tumour settings.”
The company-sponsored, open label, single arm Phase IIb AVALON trial has been designed for assessing the safety and efficacy of MVP-S and intermittent low-dose cyclophosphamide (CPA) in platinum-resistant ovarian cancer patients.
