Shaji K. Kumar, MD, hematology division at Mayo Clinic, Rochester, Minnesota presented the phase I/II multicenter study results of weekly administration of MLN9708 in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the ASH 2012 held in Atlanta. Preliminary findings of the study show promise.
MLN9708 is the first oral proteasome inhibitor to enter clinical trials and is ‘exhibiting promising anti-MM effects with a favorable toxicity profile –low rates of peripheral neuropathy.’
In the report by Dr. Kumar, of the 53 newly diagnosed patients who received 7 cycles of therapy at a dosage of 4mg, 58% achieved very good partial response rates and the overall response rate was 90%. Of the 3 patients who went on to complete 12 cycles, two have achieved complete response and one has shown very good partial response. Minimal residual disease was found to be negative in 7 patients out of the total 8 patients with complete response who were assessed. The study is continuing for further evaluations.
Dr. Kumar in CancerNetwork,
The MLN9708-based combination evaluated in this study of newly diagnosed myeloma patients, suggests a favorable emerging clinical profile. The preliminary finding of improved depth of response with extended treatment duration warrant further investigation of this all-oral combination in frontline myeloma.’
Two global phase III trials have been initiated in 2012,
- Investigating MLN9708 in combination with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma
- Investigating MLN9708 plus dexamethasone in patients with relapsed or refractory light chain AL amyloidosis.
MLN9708 is being developed by Millennium Pharmaceuticals.
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