The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s oral inhibitor abemaciclib for the treatment of patients with a specific type of breast cancer.
Abemaciclib will now be able to be used in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.
The approval was based on results from the Phase III monarchE trial which included over 5,000 patients with HR+, HER2- and a high risk of early breast cancer.
An interim analysis from the trial showed a statistical improvement in invasive disease free survival (IDFS) for patients taking abemaciclib in combination with endocrine therapy (ET) vs ET alone.1
Further analysis showed that 91% of patients in the first cohort taking the same combination therapy after two years of treatment displayed a decreased risk of breast cancer recurrence by 32% compared to standard adjuvant ET alone. This was consistent across all pre-specified subgroups and corresponds to a 3% difference in IDFS between arms (92.6% in the abemaciclib arm and 89.6% in the control arm) at two years.2
Eli Lilly states that in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
The MonarchE trial included 5,637 patients from over 600 sites in 38 countries. The first cohort had 5,120 patients enrolled into it, and were treated with a 150mg dose of baseline two times a day in combination with ET for two years, or until they met a criteria for discontinuing the treatment. Patients in both cohorts will receive five-10 years of ET, two years being in the study followed by a further three-eight years in long-term follow up.
Professor Stephen Johnston, Consultant Medical Oncologist and Head of The Breast Unit at the Royal Marsden NHS Foundation Trust, Professor of Breast Cancer Medicine at the Institute of Cancer Research, London, and Lead Global Principal Investigator for the monarchE trial, said:
“It’s a privilege to see the compelling results from the monarchE trial, which was a huge international effort, translate into a new treatment option for HR+ and HER2- breast cancer patients who have a high risk of their cancer recurring. Despite previously receiving the very best standard of care treatment, this high risk node-positive group – about 15% of all HR+ and HER2- breast cancer patients – were at considerable risk of their disease returning. This drug represents a significant breakthrough and I’m delighted that it will be available for eligible patients to help reduce their risk of recurrence.”
“This approval establishes abemaciclib as the first CDK4/6 inhibitor to be authorised for the treatment of HR+, HER2-, high risk early breast cancer and is the first successful addition to adjuvant ET in nearly two decades,” said Dr Jeff Yang, Associate Vice President – Medical, Northern Europe, Eli Lilly and Company. “We understand the importance of having treatment options and are proud abemaciclib is now available for patients. Lilly would like to thank the patients and investigators around the world, including those in the United Kingdom who have made this possible.”
2: Summary of Product Characteristics available from UKMedInfo@Lilly.com