On January 29, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported updates on its clinical program for its lead investigational treatment, DPX-Survivac, as a potential monotherapy in advanced recurrent ovarian cancer (Press release, IMV, JAN 29, 2019, View Source [SID1234534098]). In December 2018, IMV met with the U.S. Food and Drug Administration (FDA) in a Type B meeting to discuss the results-to-date of its DECIDE1 clinical trial and ongoing development plan, as well as to obtain agency guidance on a potential accelerated regulatory pathway for DPX-Survivac as a T cell immunotherapy for the treatment of advanced ovarian cancer in patients with progressing disease.
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"This FDA meeting was an important milestone for the DPX-Survivac program, and we are very pleased to be aligned with the agency on key aspects of our clinical development plan," said Frederic Ors, Chief Executive Officer at IMV. "We believe that, with no currently approved immunotherapy options available, ovarian cancer remains a serious unmet medical need. We look forward to advancing our ongoing phase 2 DECIDE study in order to potentially expedite DPX-Survivac development as a possible first-in-class T cell immunotherapy treatment for patients with advanced ovarian cancer."
FDA Meeting Highlights
The purpose of IMV’s Type B meeting with the FDA was to request feedback on the design of the clinical program for DPX-Survivac. This program includes the ongoing DECIDE phase 2 clinical study and a potential future registration trial for accelerated approval in a subset of ovarian cancer patients.
The FDA reviewed the Company’s proposed clinical development plan and acknowledged the potential for accelerated approvals in advanced ovarian cancer based on objective response rate (ORR) according to RECIST 1.1 criteria with reported median duration of response (DOR). In addition, the FDA provided important guidance on clinical design considerations for different lines of therapy and platinum-sensitive and -resistant patient populations.
In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial, and further discussed those details with the FDA during the Type B meeting. The phase 2 primary endpoint, based on objective response rate (ORR) per RECIST 1.1 criteria, is intended to confirm the high response rate and duration of clinical benefits observed in previously announced results in a patient population defined by a clinical biomarker based on baseline tumor burden (BTB).
Multiple clinical sites are now open for enrollment in the DECIDE phase 2 trial. Subject to phase 2 results, IMV plans to schedule a follow-up meeting with FDA to finalize the design of a potential pivotal trial based on ORR and DOR.
About the DECIDE Phase 2 Trial Cohort
The DECIDE (DPX-Survivac with low dose intermittent cyclophosphamide) phase 2 study is an open label safety and efficacy study for individuals with advanced platinum-sensitive and -resistant ovarian cancer with sum of base line target lesions per RECIST criteria less than 5 cm. Primary and secondary endpoints include:
Safety profile,
ORR and DOR using RECIST 1.1 criteria,
Induction of systemic survivin-specific T cells in the blood, and
Induction of T cell infiltration into tumors.