BIOVF - Swedish Orphan's avatrombopag flunks late-stage study in chemo-induced low blood platelets

A Phase 3 clinical trial evaluating Swedish Orphan Biovitrum AB's (BIOVF) Doptelet (avatrombopag) in solid tumor patients with chemo-induced thrombocytopenia (low blood platelets) failed to achieve the primary endpoint.The 122-subject study did not meet the composite endpoint of avoiding platelet transfusions, chemotherapy dose reductions by 15 per cent or greater, and chemotherapy dose delays by four days or more compared to placebo. Specifically, 69.5% of avatrombopag-treated patients were considered responders versus 72.5% of those in the control arm. In the per-protocol population, the proportions of responders were almost even, 85.0% vs. 84.4%.Avatrombopag, an oral thrombopoietin receptor agonist, was first approved in the U.S. in May 2018 for chronic liver disease patients with thrombocytopenia who are undergoing a medical procedure. The European Commission followed suit in June 2019.Swedish Orphan acquired the rights to Doptelet via its $915M takeover of Dova Pharmaceuticals in November 2019.

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Swedish Orphan's avatrombopag flunks late-stage study in chemo-induced low blood platelets