The companies collaborated to initiate P-Ib/II (ELONA) clinical PoC trial evaluating onapristone extended-release (ONA-XR) + elacestrant in patients with ER+, PR+ HER2- mBC who have prior been treated with a CDK4/6 inhibitor
The trial is expected to be initiated in Q4’22. Additionally, Context will be responsible to sponsor the clinical trial and Menarini will supply elacestrant at no cost
In a P-III trial, Elacestrant showed an improvement in PFS over SoC endocrine therapy in patients with ER+, HER2- mBC with a 30% reduction in risk of progression or death in all patients, 22% vs 9% of patients were alive and progression-free @12mos. after elacestrant treatment initiation in the overall population
Ref: GlobeNewswire | Image: Context Therapeutics