18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a 133-patient, U.S. only, randomised Phase 2 trial, which led to accelerated approval by the U.S. FDA and conditional marketing authorisation by the EMA.

Eli Lilly today reported that the results of ANNOUNCE, the Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as compared to doxorubicin, a standard of care treatment. Specifically, the study did not meet the primary endpoints of overall survival in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population. Lartruvo was well tolerated; there were no new safety signals identified and the safety profile was comparable between treatment arms.

Lilly is working with global regulators to determine the appropriate next steps for Lartruvo. While these discussions are ongoing, patients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they are receiving clinical benefit. For patients who have not previously received Lartruvo, the results of the Phase 3 trial do not support initiating treatment with Lartruvo in patients with STS, outside of participation in a clinical trial. At this time, Lilly is suspending promotion of Lartruvo.

Read Eli Lilly press release