Lilly's breast cancer study of abemaciclib demonstrated superior progression-free survival at interim analysis
The Phase III study compared abemaciclib in combination with an aromatase inhibitor versus an aromatase inhibitor alone in patients with HR+, HER2- advanced breast cancer.
Eli Lilly has announced that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS). In addition, improvement was shown in a key secondary endpoint of objective response rate (ORR). The Phase III study evaluated abemaciclib, a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, in combination with an aromatase inhibitor (letrozole or anastrozole) compared to treatment with an aromatase inhibitor alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Detailed efficacy and safety results will be presented at a medical meeting in the second half of the year.
"Today marks another important milestone in our clinical development program for abemaciclib, a drug we believe has the potential to be best in class," said Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology. "We are very excited about the results seen in patients with breast cancer, from single-agent activity to clinically meaningful benefit when used in combination with fulvestrant or aromatase inhibitors. Along with additional abemaciclib clinical trials in other tumor types, these data underscore Lilly's commitment to delivering life-changing medicines to treat and cure people living with cancer around the world."
The global Phase III, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced (locoregionally recurrent or metastatic) breast cancer who have had no prior systemic treatment for advanced disease. A total of 493 patients were randomized to receive 150 mg of abemaciclib or placebo orally twice a day without interruption, given in combination with either 1 mg of anastrozole or 2.5 mg of letrozole once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was PFS, with key secondary endpoints of ORR, overall survival and safety. The adverse events were generally consistent with previous studies of abemaciclib, with the most common adverse events being diarrhea, neutropenia, fatigue, and nausea.
Following this MONARCH 3 interim analysis, Lilly intends to begin global submissions of these results in the third quarter of 2017. In addition, Lilly intends to initiate MONARCH 1 and MONARCH 2 submissions beginning in the second quarter of 2017.
Other MONARCH trials currently underway include: monarcHER, which is evaluating abemaciclib plus trastuzumab (with or without fulvestrant) in women with HR+, HER2+ locally advanced or metastatic breast cancer, and MONARCH plus, a Phase 3 study of abemaciclib in combination with endocrine therapies to support registration in China. In addition, Lilly has an ongoing Phase 3 trial evaluating abemaciclib in lung cancer. Lilly is also evaluating abemaciclib in patients with brain metastases, as well as in patients with pancreatic cancer.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance