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First interim results from a Phase I/II study of Pidilizumab in Multiple Myeloma to be presented in the upcoming meeting of the American Society for Hematology (ASH)
Yavne, Israel, 8/11/2015: Preliminary positive data of pidilizumab in patients with multiple myeloma are to be presented in the upcoming ASH meeting in December. The ongoing study, which is conducted at the Comprehensive Cancer Center of Ohio State University is led by Don Benson, MD and Yvonne Efebera MD and is aimed to study whether the combination of pidilizumab with Revlimid (a cornerstone in the standard of care of multiple myeloma) is safe and effective in the treatment of this cancer disease.
The study which is an non randomized, open labeled Phase I/II study in patients with relapsed or refractory multiple myeloma is divided into a Phase I dose-escalation study which will be followed by a Phase II study. The preliminary results are based on data obtained for the first 12 patients who were treated with different doses of both agents under the Phase I part of the study protocol. A total of 35 patients are planned to be enrolled in the study.
Pidilizumab infusion has been well tolerated with only one grade 2 infusion related toxicity with sore throat. Grade 3/4 Anemia, neutropenia, and thrombocytopenia attributable to therapy have been seen in 25%, 23%, and 34% of patients, respectively. There has been no dose reduction in pidilizumab while Revlimid dose was reduced in 3 patients and increased in one. As of August this year, 5 patients continue on therapy at respective 12, 11, 9, 5 and 3 months. So far, ORR has been 31% (3 very good partial responses and 1 partial response), 2 patients showed minimal response and 2 stable disease totaling in 67% disease control rate.
The investigators conclude that the combination of steroid sparing pidilizumab and Revlimid regimen has so far demonstrated an acceptable toxicity profile with evidence of anti-myeloma activity.
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