Interim analysis fails to show benefits for Lilly’s abemaciclib in advanced breast cancer
pharmafile | August 10, 2016 | News story | Research and Development | Eli Lilly, abemaciclib, breast cancer
Eli Lilly has announced that, after a pre-planned interim analysis for their Phase III MONARCH2 trial, investigators have decided to continue the study without modification, despite the interim efficacy criteria not being met for trial candidate abemaciclib, plus fulvestrant, in locally advanced or metastatic breast cancer.
Abemaciclib is an investigational drug designed to block cancer cell growth by specifically inhibiting cyclin-dependent kinases, CDK 4 and CDK 6. Pfizer got the head start on these forms of cancer therapy, when Ibrance (palbociclib) was approved in 2014. Novartis recently made gains in this area, as LEE011 (ribociclib) performed well enough in trials to warrant a breakthrough therapy designation.
In the MONARCH 2 trial, abemaciclib is being used in combination with Faslodex (fulvestrant) and compared with placebo in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. It enrolled 669 patients across 142 worldwide sites, with a primary endpoint of progression-free survival.
The trial will now continue into 2017, with results providing a full analysis of progression-free survival, overall survival and safety data. With regulatory hurdles to overcome, if abemaciclib manages to improve over the remainder of the trial, then the earlies likely date for a product launch would be 2018.
Shares at Eli Lilly were down 2% at the time of writing.
Sean Murray
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