IMV has revised its Phase Ib/II clinical trial investigating the safety and efficacy of DPX-Survivac in combination with epacadostat for the treatment of patients with recurrent ovarian cancer.
The trial examined the combination of 100mg or 300mg epacadostat and DPX-Survivac.
IMV's revision is based on findings from the Phase Ib part of the trial that showed complete tumour regressions and disease control rate in patients treated with 100mg epacadostat.
The trial observed long duration clinical benefit in responders with a median period of 590 days, with one patient passing the two-year mark without disease progression.
It also revealed that the safety profile of DPX-Survivac is similar to that observed in previous studies conducted by IMV.
Based on results from the 300mg cohort, IMV has decided to stop dosing patients with epacadostat and plans to continue the trial to investigate DPX-Survivac as a monotherapy in the recurrent ovarian cancer subpopulation.
IMV CEO Frederic Ors said: “The goal of the trial was to evaluate combination therapies. However, the new data indicates that DPX-Survivac shows activity as a monotherapy in late-stage patients, which can potentially translate into clinical benefit.
“In parallel to the amended monotherapy trial, we will continue to investigate other combinations with our lead product candidate as we continue our work to deliver new immunotherapy options that may benefit more patients in multiple cancers.”
The company intends to meet US Food and Drug Administration (FDA) representatives in December to present results related to the subpopulation of the Phase Ib/II study.