The FDA recommends that no new patients with advanced soft tissue sarcoma (STS) be treated with olaratumab (Lartruvo) plus doxorubicin, following the negative results of the phase III ANNOUNCE trial.1
The agency’s statement follows the January 2019 announcement that olaratumab in combination with doxorubicin missed the trial’s primary endpoint of overall survival (OS) and did not confirm a clinical benefit for patients with advanced or metastatic STS compared with standard doxorubicin.2 The OS endpoint in the leiomyosarcoma subpopulation also was not met.
“[T]he FDA recommends that patients who are currently receiving Lartruvo should consult with their healthcare provider about whether to remain on the treatment,” the FDA stated in a press release. “The FDA also recommends that Lartruvo should not be initiated in new patients outside of an investigational study.”
According to the statement, patients currently receiving olaratumab may continue to receive the treatment if they appear to be benefiting from it.
Results of ANNOUNCE (NCT02451943), which was the confirmatory trial for the FDA olaratumab’s approval in this setting, showed no difference in OS between the 2 arms. The median OS was 20.4 months with olaratumab/doxorubicin and 19.7 months with doxorubicin (HR, 1.05). In the leiomyosarcoma subpopulation, the median OS was 21.6 months and 21.9 months for olaratumab/doxorubicin and doxorubicin alone, respectively. The median PFS with olaratumab/doxorubicin was 5.4 months and 6.8 months with doxorubicin alone (HR, 1.23).
Olaratumab was well tolerated, and no new safety signals were reported. Eli Lilly stated in a press release that the phase III data do not support starting patients on the therapy outside of a clinical trial.
1. FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma. FDA. Published October 19, 2016. Updated January 24, 2019. https://bit.ly/2CO8eVd. Accessed January 24, 2019.
2. Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO®. Eli Lilly and Company. Published January 18, 2019. https://bit.ly/2RXHz1W?rel=0" . Accessed January 18, 2019.