publication date: Sep. 21, 2018
Early positive results from phase II DPX-Survivac + Keytruda in DLBCL
IMV Inc. announced that investigators are evaluating IMV’s lead candidate, DPX-Survivac, in combination with low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda (pembrolizumab), in patients with persistent or recurrent/refractory diffuse large B-cell lymphoma.
The preliminary data included assessment of safety and clinical activity (based on modified Cheson criteria) for the first four evaluable patients who have completed their first CT scan after the start of treatment. The data showed that:
Two of the first four evaluable participants showed tumor regressions at the first on-treatment CT scan.
The first enrolled participant demonstrated a tumor regression of 48% at first on-treatment scan;
The second participant demonstrated a partial response (PR) via a tumor regression of 66% at first on-treatment scan.
Preliminary data from the third participant demonstrated stable disease.
The other participant had early disease progression less than two months following treatment initiation and was discontinued from the study.
The combination therapy appears to demonstrate an acceptable safety profile, with no serious adverse events reported to date.
The trial is expected to enroll 25 evaluable participants whose DLBCL expresses survivin, a tumor antigen expressed in approximately 60 percent of DLBCL patients.
Sunnybrook Health Sciences Centre clinicians have, to date, enrolled four patients. Investigators have also started screening and recruiting patients at two additional sites: Ottawa Hospital Research Institute and the Research Institute of the McGill University Health Centre.
The study’s primary endpoint is to document the objective response rate. Secondary objectives include measuring tumor regression, and documenting the toxicity profile and durations of response. In addition, researchers will perform analyses to assess … Continue reading Early positive results from phase II DPX-Survivac + Keytruda in DLBCL
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