The European Commission (EC) has granted conditional marketing authorisation for Eli Lilly and Company’s (LLY) olaratumab injection of 10mg/ml in combination with doxorubicin, to treat adults with advanced soft tissue sarcoma (STS) who are not suited for curative surgery or radiotherapy and were not previously treated with doxorubicin.
Olaratumab is a recombinant, human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα, thereby blocking PDGF-AA, PDGF-BB and PDGF-CC binding and receptor activation.
Data from the Phase II portion of the pivotal JGDG trial has paved the way for the conditional marketing authorisation followed by a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), which reviewed olaratumab under the European Medicines Agency’s accelerated assessment programme.
The open-label, randomised Phase Ib/II JGDG study compared olaratumab and doxorubicin chemotherapy with the control arm of doxorubicin alone in patients with unresectable, advanced STS.
After confirmation of safety in the Phase Ib portion of the study, 133 doxorubicin-naïve patients were randomised in the study's Phase II portion to be treated with olaratumab and doxorubicin combination and doxorubicin alone.
Results suggested that olaratumab-doxorubicin arm achieved median progression free survival, as well as overall survival (OS) compared to doxorubicin arm.
JGDG registration trial investigator and the Institute of Cancer Research in London team leader and the Royal Marsden sarcoma unit head and consultant medical oncologist Dr Robin L Jones said: “Olaratumab, in combination with doxorubicin, has demonstrated improved overall survival compared to doxorubicin alone in advanced soft tissue sarcomas, and is a promising new agent in these tumours.”
As part of the conditional marketing authorisation, Lilly will update results from an ongoing Phase III ANNOUNCE study, until which olaratumab will be subject to CHMP review annually to determine whether the conditional marketing authorisation can be maintained.