Olaratumab was authorised in the European Union in November 2016 to treat advanced soft tissue sarcoma. At time of its approval, data on effects of olaratumab were limited due to small number of patients included in main study that supported conditional authorisation as an orphan drug. The medicine was therefore granted a marketing authorisation on condition that the company provided additional data from the ANNOUNCE study to confirm efficacy and safety of medicine.
The ANNOUNCE study failed to show any clinical benefit of olaratumab in combination with doxorubicin compared with doxorubicin, a standard of care treatment for advanced soft tissue sarcoma. Specifically, study of 509 patients (258 in investigational arm and 251 in control arm) did not meet the primary endpoint to prolong OS (HR, 1.05; 95% CI, 0.84-1.30; median OS 20.4 in investigational arm vs 19.8 months in control arm).
OS was also not prolonged by olaratumab in subpopulation of 234 patients with leiomyosarcoma (119 in investigational arm and 115 in control arm; HR, 0.95; 95% CI, 0.690-1.312; median OS, 21.6 in investigational arm vs 21.9 months in control arm).
There was no clinical benefit for key secondary efficacy endpoints, including median PFS (HR, 1.23; 95% CI, 1.009-1.502; median PFS 5.4 in investigational arm vs 6.8 months in control arm).
No new safety concerns were identified in the study. Because this study did not show a clinical benefit, conditional marketing authorisation for olaratumab will be withdrawn. Not to start new patients on olaratumab, for patients currently on treatment, consider alternative treatment options since available stock will expire by April 2020.
Healthcare professionals are advised to report suspected ADRs associated with black triangle medicines via the Yellow Card Scheme.
