logo
Share SHARE
FONT-SIZE Plus   Neg

Lilly: Phase 3 MONARCH 2 Breast Cancer Study Of Abemaciclib Met Primary Endpoint

Eli Lilly and Co. (LLY) announced Monday that its MONARCH 2 breast cancer Study trial of abemaciclib met the primary endpoint of progression-free survival. Abemaciclib, in combination with fulvestrant, was superior to fulvestrant plus placebo in patients with HR+, HER2- advanced breast cancer, the company noted.

The Phase 3 study evaluated abemaciclib, a cyclin-dependent kinase or CDK 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive or HR+, human epidermal growth factor receptor 2-negative, advanced breast cancer who have relapsed or progressed after endocrine therapy.

The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS, when compared to the control arm of placebo plus fulvestrant. Detailed efficacy and safety results will be presented at an upcoming medical meeting.

The global Phase 3, double-blind study was designed to evaluate the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with advanced breast cancer.

The most common adverse events observed were diarrhea, neutropenia, nausea and fatigue, and were consistent with the previous studies of abemaciclib.

Lilly intends to submit a new drug application or NDA for single-agent abemaciclib in the second quarter of 2017, based on the MONARCH 1 study.

Lilly plans to submit an additional application for MONARCH 2 in the third quarter of this year.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alteryx, Inc., a provider of self-service data analytics software, is the latest tech company to go public in March. Alteryx said it has priced its IPO of 9 million shares of its Class A common stock at $14 per share, at the top end of its range of $12 to $14 per share. Dunkin' Donuts is bidding adieu to one of its frozen coffee beverages this summer. However, loyal fans of the decades-old menu staple have not taken kindly to the news. The coffee chain said it will discontinue its popular Coffee Coolatta beverage this summer and instead, introduce the new Frozen Dunkin' Coffee, made with coffee extract, sugar and milk. Canadian pipeline operator Enbridge Inc. said it will cut about 1,000 jobs, or six percent of its workforce, following the completion of its acquisition of Houston-based Spectra Energy Corp. The job cuts will take place across the merged company.
comments powered by Disqus
Follow RTT