Shionogi & Co. announced it will present positive efficacy and safety results from a global phase III study (L-PLUS 2) of lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, at the 2017 American Association for the Study of Liver Diseases (AASLD) Liver Meeting to be held October 20-24 in Washington, D.C.
L-PLUS 2 was a multi-national, double-blind, placebo-controlled study conducted in 22 countries to evaluate lusutrombopag for the treatment of thrombocytopenia in patients with chronic liver disease undergoing planned, non-emergent invasive procedures. L-PLUS 2 was the second of two phase III studies of lusutrombopag demonstrating confirmatory data to support the previously reported L-PLUS 1 trial. A total of 215 patients were randomized 1:1 to receive 3mg of lusutrombopag (n=108), or placebo (n=107), up to seven days. Therapy was initiated on Day 1 and invasive procedures were performed between day nine and day 14. A pre-procedure platelet transfusion was mandated by the study protocol if a patient's platelet count prior to the invasive procedure had not reached 50,000/µL.
Key findings from the L-PLUS 2 study will be presented in a late-breaking oral session on Monday, October 23 and include the following:
"There is a clear, unmet need for additional treatment options for our chronic liver disease patients with significant thrombocytopenia, as platelet transfusion is currently their only choice." said Dr. Nezam Afdhal, Director of Hepatology at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School. "The safety and efficacy of lusutrombopag may give clinicians an additional option for the treatment of thrombocytopenia in liver disease patients undergoing invasive procedures."
Lusutrombopag has been granted Fast Track designation by the FDA for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with elective invasive procedures. Shionogi has initiated rolling submission of a New Drug Application to the FDA. Shionogi plans to present L-PLUS 2 study data at the 25th United European Gastroenterology Week in Spain later this month, and at the American Society of Hematology meeting in December.