Phase 3 Results Announced for Lusutrombopag for Thrombocytopenia
Lusutrombopag has already been granted Fast Track status by the FDA
Shionogi announced positive results from the Phase 3 study of its investigational drug, lusutrombopag (S-888711), to potentially treat thrombocytopenia in patients with chronic liver disease undergoing non-emergent invasive procedures.
The double-blind, placebo-controlled trial, L-PLUS2, included a total of 215 patients who were randomized 1:1 to either lusutrombopag 3mg or placebo for up to 7 days. The primary endpoint was the number of patients who required no platelet transfusion priory to primary invasive procedure and no rescue therapy for bleeding for 7 days post-procedure.
The results showed that 64.8% of the lusutrombopag treatment group met the primary endpoint vs. 29.0% of the placebo group. The lusutrombopag group also showed superiority in the secondary endpoints with 64.8% achieving a platelet count of ≥50,000/µL and an increase of ≥20,000/µL from baseline compared to 13.1% of patients taking placebo.
Bleeding-related adverse events were seen in 2.8% of lusutrombopag patients vs. 5.6% of the placebo patients. These results proved similar to the safety and efficacy outcomes from the Phase 3 L-PLUS1 study, a similar study conducted in Japan.
Lusutrombopag is an oral, small molecule agonist of human thrombopoietin (TPO) receptor. It has already been granted Fast Track status by the FDA and the company has initiated a rolling submission of its New Drug Application.
“Patients with chronic liver disease and thrombocytopenia undergoing non-emergent invasive procedures currently have no approved medical treatment options except for platelet transfusions, therefore therapeutic options in this area are critically needed,” said Dr. Tsutae Nagata, Chief Medical Officer of Shionogi.
For more information visit Shionogi.com.