ANNOUNCEment.

Sarcoma sure does seem to suffer during our annual government shutdowns. Last week Eli Lilly announced its wonder drug olaratumab did not, in fact, improve overall survival among a large cohort of patients treated for unresectable sarcoma in the phase 3 ANNOUNCE trial. You may remember its phase 2 predecessor making headlines with reports of an almost doubling of overall survival with the addition of olaratumab. Sure, there were concerns about there being no correlation between overall and progression-free survival times. And about the post-hoc realization that the assay for PDGFRɑ (aka the drug target) didn’t actually work. Oops. But none of that was enough to stop the FDA from granting it accelerated approval, allowing patients to receive olaratumab in combo with doxorubicin off-trial since 2016. At least olaratumab was “well-tolerated,” perhaps due to most recipients not harboring a target for the drug. TBL: Olaratumab is no longer recommended as systemic therapy for sarcoma, and phase 2 trials are only meant to signal the utility of pursuing phase 3 confirmation. | Eli Lily 2019