Takeda aims at Bristol and Merck

Takeda’s anti-activin A fusion protein elritercept, gained via its $200m deal with Keros, is one of its big cancer hopes, and the Japanese company has just broadened its phase 3 programme to include first-line myelodysplastic syndromes.

If elritercept succeeds here, it could challenge Bristol Myers Squibb and Merck & Co’s Reblozyl, which already has FDA approval in first-line transfusion-dependent MDS, and sold a surprisingly hefty $2.3bn last year. Bristol is a step ahead, though, and is now shooting for first-line transfusion-independent disease, where the Element-MDS trial is set to report in 2027. Still, other recent readouts haven’t gone to plan.

Another rival is Geron, but that group’s Rytelo is only indicated for second-line MDS. That company’s expansion efforts appear to be focused on second-line myelofibrosis, with the ImpactMF trial due to yield data this year. Rytelo sold $184m in 2025.

Elrise

Takeda, meanwhile, will soon have two pivotal trials of elritercept under way. The latest, Elrise-MDS, is set to start in April, and will enrol patients with transfusion-dependent anaemia due to very low, low, or intermediate-risk MDS, who haven’t previously received erythropoiesis-stimulating agents (ESAs).

It will compare elritercept against the ESA epoetin alfa, with a primary endpoint of transfusion independence. This is defined as avoiding red blood cell transfusions for any consecutive period of 12 weeks or more, from day one to week 24 of therapy; patients also have to have a concurrent mean haemoglobin increase of 1.5g/dl or more from baseline.

In its first-line trial, Commands, Reblozyl produced a transfusion independence rate of 59%, versus 31% with epoetin alfa, setting a benchmark for elritercept to hit.

Renew

An earlier trial, Renew, compares elritercept versus placebo, also in transfusion-dependent anaemia due to very low, low, or intermediate-risk MDS, but in patients who are refractory or intolerant to prior ESAs, or deemed unlikely to respond to ESAs.

Renew includes patients both with and without ringed sideroblasts; in the post-ESA population Reblozyl only has the nod in those with ringed sideroblasts, while Rytelo is indicated regardless of ringed sideroblast status.

Renew’s primary endpoint is also transfusion independence. However, here this is defined as no infusions for at least eight weeks after the first dose of the study treatment until week 24. In Geron’s Imerge trial, 40% of Rytelo-treated patients achieved transfusion independence, versus 15% of the placebo group.

Takeda will presumably need to see something similar with elritercept. The group has been building its oncology presence via a series of small deals, but last year went bigger with a $1.2bn tie-up with Innovent covering the anti-PD-1 x IL-2 fusion protein IBI363, the anti-Claudin18.2 ADC arcotatug tavatecan, and an option over a bispecific anti-EGFR x B7-H3 ADC, IBI3001.

Phase 3 studies of elritercept in transfusion-dependent anaemia in very low to intermediate-risk MDS

Notes: ESA=erythropoiesis-stimulating agent; *for ≥8wks after the first dose through wk 24; **for consecutive ≥12wks from day 1 through 24 weeks, with concurrent mean haemoglobin increase ≥1.5g/dl. Source: OncologyPipeline.