Takeda Oncology yesterday announced posi­tive results from a key trial testing the in­ves­ti­ga­tional drug ixazomib in re­lapsed multiple myeloma patients.

Participants in the large Phase 3 ixazomib ^[1] trial, known as the TOUR­MA­LINE MM-1 study, received one of two possible treat­ment regi­mens. One group was treated with ixazomib, Revlimid ^[2] (lena­lido­mide), and dexa­metha­sone ^[3] (Decadron), while the other group received a placebo (sugar pill), Revlimid, and dexa­metha­sone.

Investigators conducting the trial recently carried out the first planned interim analysis of the study results. Their analysis, Takeda reported yesterday, found that patients in the trial who received ixazomib had longer pro­gres­sion-free sur­vival than those in the placebo arm of the trial.

Progression-free survival is the key out­come being measured during the trial, and the difference in the sur­viv­al measure between the two arms of the trial was statistically significant, Takeda said.

Takeda has not yet reported, however, specific results from the trial, such as median pro­gres­sion-free survival in each arm of the study.

The new results, Takeda said in its announcement, will be used by the com­pany as the basis for applications it intends to file in the U.S. and other countries to have ixazomib approved as a new treat­ment for re­lapsed multiple myeloma.

Takeda has said in the past that it expects to make such regulatory submissions sometime between April of this year and March next year, with potential approval decisions coming in the fol­low­ing 12 months.

Based on Takeda’s public statements and discussions with financial analysts, The Beacon cur­rently fore­casts that Takeda will submit ixazomib for approval in the U.S. and Europe by sometime this summer. De­ci­sions on these regulatory submissions would then occur around the second quarter of 2016.

Ixazomib, which also is known by its codename, MLN9708, is a proteasome inhibitor. This class of drugs includes Velcade ^[4] (bor­tez­o­mib) and Kyprolis ^[5] (car­filz­o­mib).

Unlike Velcade and Kyprolis, which are admin­istered by injection or infusion, ixazomib is given orally as a capsule. Another orally-administered proteasome inhibitor, oprozomib ^[6], is also under devel­op­ment, but it is not as far along in the clinical trial process as ixazomib.

Due to their convenience, orally admin­istered myeloma ther­a­pies are considered attractive options for use in main­te­nance ther­apy, where convenience of admin­istra­tion can be an important factor.

Takeda Oncology’s U.S. arm, Millennium Pharmaceuticals, developed Velcade and markets it in the U.S.  Kyprolis is marketed by the Onyx sub­sid­i­ary of Amgen, which also is developing oprozomib.

The TOURMALINE MM-1 trial is an inter­na­tional, double-blind study involving more than 700 multiple myeloma patients. Participants in the study had to have re­lapsed and/or refractory disease and have been treated with one to three prior myeloma treat­ment regi­mens.

For addi­tional in­­for­ma­tion, see the Takeda Oncology press release ^[7] and in­­for­ma­tion about the TOUR­MA­LINE MM-1 ^[8] study at clinicaltrials.gov.