Eli Lilly and Company has been recommended to continue its MONARCH II trial without any modification to compare a combination of abemaciclib and fulvestrant against placebo with fulvestrant to treat locally advanced or metastatic breast cancer.
The recommendation was made by an independent Data Monitoring Committee (DMC) after completing a pre-planned interim analysis for MONARCH II, which suggested that the trial did not fulfill its interim efficacy criteria.
Lilly oncology product development and medical affairs senior vice-president Richard Gaynor said: "We had stringent criteria set for this interim analysis and we look forward to receiving the final MONARCH II results in the first half of 2017.
"We remain optimistic that treatment with abemaciclib, in combination with fulvestrant, could offer improved outcomes for patients."
Abemaciclib (LY2835219) is an investigational, oral-cell cycle inhibitor that been developed to inhibit cancer cell growth by specifically blocking cyclin-dependent kinases, CDK 4 and CDK 6.
Faslodex (fulvestrant) is an anti-estrogen medication used to treat hormone receptor positive breast cancer.
The MONARCH II Phase III trial involved 669 patients who were administered with abemaciclib or placebo orally combined with fulvestrant after every 12 hours until disease progression.
The trial was primarily focused on determining the progression-free survival (PFS) induced by the drug combination.
It included patients who experienced the disease progression on or within 12 months after being administered with endocrine treatment in the neoadjuvant or adjuvant setting, or while receiving first-line endocrine therapy for metastatic disease.
Patients who have been subjected to chemotherapy in the metastatic setting were not eligible for the trial.
Conducted across 142 sites worldwide, the MONARCH II trial was designed to test the safety and efficacy of abemaciclib in combination with fulvestrant.
The MONARCH II trial will be undertaken in the first half of next year and analyse the PFS, overall survival and safety data.
The company now intends to begin MONARCH III, a Phase III trial of abemaciclib in combination with a non-steroidal aromatase inhibitor in patients with HR+, HER2- loco-regionally recurrent or metastatic breast cancer.