Olaratumab (Lartruvo) in combination with doxorubicin missed the phase III ANNOUNCE trial’s primary endpoint of overall survival (OS) and did not confirm a clinical benefit for patients with advanced or metastatic soft tissue sarcoma (STS) compared with standard doxorubicin, according to Eli Lilly and Company, the manufacturer of olaratumab.1
The OS endpoint in the leiomyosarcoma subpopulation was also not met.
“As ANNOUNCE did not confirm clinical benefit, Lilly is working with global regulators to determine the appropriate next steps for Lartruvo,” the company stated in a press release. “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 olaratumab, Eli Lilly added that the phase III data do not support starting this therapy in patients with STS outside of a clinical trial.
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