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ANNOUNCE: A randomized, placebo (PBO)-controlled, double-blind, phase (Ph) III trial of doxorubicin (dox) + olaratumab vs dox + PBO in patients (pts) with advanced soft tissue sarcomas (STS)

Journal of Clinical Oncology Jun 13, 2019

Tap WD, et al. - Given that an improved overall survival (OS) and progression-free survival (PFS) in STS patients has been achieved with olaratumab (a human IgG1 antibody targeting PDGFRα) + dox vs dox in a Ph 2 trial, researchers intended to corroborate the OS benefit in advanced STS in ANNOUNCE. Eligible participants were adult pts with unresectable locally advanced or metastatic STS, anthracycline-naïve, and ECOG PS 0-1. In a randomized 1:1 manner, they assigned pts to receive olaratumab (20mg/kg Cycle 1, 15mg/kg subsequent cycles) or PBO on Days 1 and 8 of each 21-day cycle combined with dox (75mg/m2) on Day 1 for up to 8 cycles. Following 8 cycles, olaratumab or PBO were continued until progression or toxicity in pts with disease control. Overall 509 pts were randomized. Findings in the ANNOUNCE did not corroborate that olaratumab + dox, followed by olaratumab monotherapy, improves OS over dox in pts with advanced STS.
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