New treatment for some high-risk breast cancer patients approved following study led by Royal Marsden researchers

19 May 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation (MA) for a new treatment for HR+ and HER2- breast cancer patients at high risk of recurrence, following results from a study led by Royal Marsden researchers.

Prof Stephen Johnston
Pictured: Professor Stephen Johnston, Lead Global Principal Investigator for the monarchE trial

Eligible patients will now have access to abemaciclib, a type of targeted drug, in combination with hormone therapy. The treatment is taken following standard therapies, such as surgery, chemotherapy, and radiotherapy, to reduce the risk of recurrence.

This authorisation was based on results from the Phase 3 monarchE trial which involved over 5,600 patients from 38 countries, with The Royal Marsden as the lead centre for this large international study.

The trial found a 32% reduction in recurrence of cancer when abemaciclib for two years was added to the standard hormone therapy compared to the hormone therapy alone. Over the first three years of the study, 17.1% of patients in the control group had a relapse of their cancer compared to 11.4% of those in the abemaciclib group.

Approximately 70% of breast cancer patients have hormone receptor positive tumours, and of those a proportion of patients will have a higher risk of relapsing in the first two of years. Patients with disease that has spread to lymph nodes, a large tumour size at the time of diagnosis, or an increased cellular proliferation (determined by high grade of the tumour, or number of dividing cells) are also considered to be at “high risk” of recurrence.

Secondary school teacher Emma Sola (48 from Brighton) was diagnosed with Stage 3 HR+ breast cancer in 2018, which had spread to her lymph nodes. She was treated with a mastectomy, chemotherapy, radiotherapy, and hormone therapy at her local hospital and, because she is considered at high risk of recurrence, was accepted onto the monarchE trial at The Royal Marsden. She said:

“When I found out I had breast cancer, I was absolutely horrified. I was told that my diagnosis meant my prognosis was poor and I had a low chance of surviving beyond ten years. My son was just eight at the time and I was frightened for him.

“I finished treatment in February 2019, and I was recommended for the monarchE trial. I was really keen as I was told it could reduce the risk of my cancer returning. Joining the trial also meant I received a lot of support at a difficult time, as I was quite scared of finishing treatment and the safety net of regular appointments. The Royal Marsden is a warm place where there is a lot of love and, along with lots of support with the trial, I received help for my mental health and issues with the menopause.

“I tolerated abemaciclib quite well and took it for 18 months. However, as I am in the trial for life, I still have regular appointments. Knowing that my risk of recurrence is lower because I’ve had this drug is incredibly reassuring. It’s like an extra layer of security.

“Since 2018, I’ve come a long way physically and mentally and have done things I couldn’t have imagined doing when I was first diagnosed. For example, in the last year, I was promoted to head of English and bought a new house to renovate. I now feel as if cancer is no longer in control of my life – I am.”

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.”

The monarchE trial was funded by Eli Lilly pharmaceutical. Early phase trials, including MONARCH 2 and MONARCH 3, investigating the efficacy of abemaciclib was supported by the NIHR BRC at The Royal Marsden and ICR. 

Breast cancer research at The Royal Marsden is funded by The Royal Marsden Cancer Charity and National Institute for Health and Care Research.

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