OBJECTIVE: To review and summarize data on olaratumab, which was approved by the 
US Food and Drug Administration (FDA) in October 2016, in combination with 
doxorubicin, for the treatment of advanced soft tissue sarcoma.
DATA SOURCES: A literature search using PubMed was conducted using the search 
terms olaratumab, IMC-3G3, and advanced soft tissue sarcoma from January 2005 to 
June 2017.
STUDY SELECTION AND DATA EXTRACTION: The literature search was confined to human 
studies published in English. Trials of olaratumab for advanced soft tissue 
sarcomas were prioritized.
DATA SYNTHESIS: Olaratumab is a human antiplatelet-derived growth factor 
receptor α monoclonal antibody. Its accelerated FDA approval was based on a 
phase II randomized trial of olaratumab plus doxorubicin (n = 66) versus 
doxorubicin monotherapy (n = 67) in patients with advanced soft tissue sarcoma. 
Olaratumab 15 mg/kg was administered intravenously (IV) on days 1 and 8 in 
combination with doxorubicin 75 mg/m2 IV on day 1 every 21 days for a total of 8 
cycles compared to doxorubicin 75 mg/m2 IV monotherapy. The response rate was 
18.2% with combination therapy versus 11.9% with monotherapy and median 
progression-free survival of 6.6 and 4.1 months, respectively. Additionally, 
overall survival was increased by 11.8 months in the olaratumab arm (26.5 months 
vs 14.7 months). Clinically relevant adverse effects in the olaratumab + 
doxorubicin arm included neutropenia (58%), mucositis (53%), nausea (73%), 
vomiting (45%), and diarrhea (34%).
CONCLUSION: Olaratumab, in combination with doxorubicin, represents a novel 
treatment strategy for advanced soft tissue sarcoma and provides a significant 
survival advantage for this rare disease state with limited treatment options.