Lilly to continue Phase III abemaciclib trial, despite failed goals

Following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) recommended the study continue without modification as the interim efficacy criteria were not met, says US pharma major Eli Lilly (NYSE: LLY). The company’s shares dipped 1.3% to $80.44 in the news.

The MONARCH 2, Phase III trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

"We had stringent criteria set for this interim analysis and we look forward to receiving the final MONARCH 2 results in the first half of 2017," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology. "We remain optimistic that treatment with abemaciclib, in combination with fulvestrant could offer improved outcomes for patients," Dr Gaynor added.