IMV Moves to Develop DPX-Survivac as Monotherapy for Recurrent Ovarian Cancer
Review of new data from the phase 1b portion of the clinical trial demonstrate a high response rate and a durable clinical benefit in a subpopulation of patients with a clinical marker predictive of a response to DPX-Survivac and correlated to its novel mechanism of action (MOA). New data include:
- Efficacy signals in the subpopulation of patients who received 100 mg dose epacadostat (n=5) included 100% tumor regressions and 100% disease control rate; and 60% of these patients (3/5) reached a best response of a partial response (PR);
- Long duration of clinical benefit observed in responders with a median duration of 590 days, including one patient that has passed the two-year mark without disease progression;
- Clinical benefit correlated to DPX-Survivac’s MOA and clinical study primary endpoints: survivin-specific T cells in the blood and T cell infiltration into tumors; and,
- The safety profile of DPX-Survivac is consistent with the profile observed in the Company’s previously reported studies.
Based on 300 mg cohort results, IMV and Incyte have agreed to stop dosing patients with epacadostat. IMV will continue the phase 1b/2 trial as a monotherapy study evaluating DPX-Survivac in the recurrent ovarian cancer subpopulation. IMV will inform and work with investigators to appropriately modify the study in a manner consistent with the best interests of each patient.
IMV and Incyte will continue to explore the potential of additional combination studies.
“The goal of the trial was to evaluate combination therapies. However, the new data indicate that DPX-Survivac shows activity as a monotherapy in late-stage patients, which can potentially translate into clinical benefit,” said
IMV is planning to meet with the
“We are very pleased that the phase 1b trial results to date validate the mechanism of action of DPX-Survivac, helping us to identify patients more likely to benefit from our drug candidate,” said
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Source: IMV Inc.