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Takeda’s Ninlaro extends myeloma survival in trial

Published on 07/12/15 at 03:52pm

Takeda has presented trial data showing that treatment with its oral proteasome inhibitor Ninlaro extended progression free survival by 35% in patients with relapsed and/or refractory multiple myeloma.

The TOURMALINE-MM1 trial of 722 patients compared the performance of once-weekly oral Ninlaro (ixazomib) plus Celgene’s Revlimid (lenalidomide) and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

Patients in the Ninlaro arm of the study lived for a significantly longer time without their disease worsening compared to patients in the control arm (20.6 months vs 14.7 months), meaning the trial met its primary endpoint. People in the Ninlaro group had an overall response rate (ORR) of 78.3% and the median duration of their response was 20.5 months, compared with 71.5% and 15 months in the control group.

Adverse events in the Ninlaro combination group were consistent with reported safety profiles for the individual drugs. The most common were neutropenia, anaemia, thrombocytopenia and pneumonia, as well as gastrointestinal reactions.

However peripheral neuropathy rates were higher in the Ninlaro group, at 28%, than the 21% in the control group. Rash was also  more common in the Ninlaro group than in the control group (35% vs 21%), while rates of acute renal failure (8% vs 10%) and heart failure (4% vs 3%) were similar in both groups.

The trial data were presented Monday at the 57th annual meeting of the American Society of Haematology (ASH).

Ninlaro was recently approved by the FDA in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The approval was based on the Phase III TOURMALINE-MM1 data, which included eight clinical trial centres in the UK.

The drug is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) in July.

Andy Plump, Takeda’s chief medical and scientific officer, comments: “The breadth and depth of the TOURMALINE program allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib. We will continue this and other important clinical trials and look forward to sharing results over the next few years.”

Approximately 4,800 people each year in the UK are diagnosed with multiple myeloma, with the disease affecting more men than women. It is the second most common form of blood/bone marrow cancer.

While treatment advancements over the last decade have meant that five-year survival rates in MM are increasing at the fastest rate among all cancer types in the UK, it remains an incurable cancer requiring new and/or improved treatments in order to extend life expectancy and improve quality of life.

On this basis, Eric Low, chief executive of Myeloma UK, welcomed the trial data, saying: “These results are very exciting for patients. The improvement in progression free survival in this difficult-to-treat stage of myeloma is extremely significant. In addition, its ability to work well in the sub-group of patients with high-risk disease, its relatively low side-effect profile and its oral administration means that ixazomib will be a very welcomed addition to the treatment armoury for this serious and complex cancer.’’

The TOURMALINE-MM1 trial is currently ongoing; patients will be treated to progression and evaluated for long-term outcomes.

Joel Levy

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