AsianScientist (Dec. 12, 2013) – Takeda Pharmaceutical Company Limited has announced final Phase I and preliminary Phase II results of a study, combining oral investigational MLN9708 administered twice a week with lenalidomide and dexamethasone, in patients with newly diagnosed multiple myeloma (MM).
The investigators reported a combined complete response and very good partial response (CR+VGPR) rate of 76 percent (46/62) and a 94 percent overall response rate (ORR; 58/62 ≥ partial response). Stringent complete response (sCR) was reached in 75 percent of patients that attained CR. Overall, drug-related serious adverse events (SAEs) were reported in 28 percent of patients (18/64), and drug-related grade 3 adverse events (AEs) in 58 percent of patients (37/64). There were no drug-related grade 4 AEs.
These data were presented at the 55th American Society of Hematology.
“This all-oral MLN9708, lenalidomide and dexamethasone study generated high response rates and increased depth of response with extended treatment duration in newly diagnosed multiple myeloma patients,” said lead investigator, Paul G. Richardson, from the Dana-Farber Cancer Institute in US. “This is the first all-oral proteasome inhibitor, IMiD combination under investigation in this setting to date, and the data support its feasibility and activity.”
MLN9708 is an investigational, oral proteasome inhibitor being developed for the treatment of patients with MM and amyloid light-chain (AL) amyloidosis. It is the first oral proteasome inhibitor to enter Phase III clinical trials.
“The safety profile and encouraging response rates presented at ASH for the twice-a-week oral MLN9708 combination supplement our clinical understanding of this all-oral triplet regimen in newly diagnosed multiple myeloma patients,” said Michael Vasconcelles, Head, Oncology Therapeutic Area Unit.
”Bringing new therapies to patients is an important goal, and the oral MLN9708 combination has the potential to become yet another way to extend proteasome inhibition. Based on data from this and another Phase I or II study, we are further exploring oral MLN9708 in our TOURMALINE Phase 3 development program using a once-a-week dosing schedule.”
Source: Takeda Pharmaceutical Company Limited; Photo: tyfn/Flickr/CC.
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