New drug combination recommended by NICE for women with advanced her2+ breast cancer following Royal Marsden trial

The National Institute for Health and Care Excellence (NICE) has recommended tucatinib, a type of targeted treatment, in combination with trastuzumab, another targeted treatment, and capecitabine, a chemotherapy, for previously treated patients with HER2-positive locally advanced or metastatic breast cancer. 

Vicki McGinn
Vicki McGinn, HER2CLIMB trial participant

This is the only clinically proven targeted drug combination that can extend overall survival in this patient group, as demonstrated by the HER2CLIMB study, a global, randomised, double-blind, phase II trial, which was supported by Royal Marsden researchers.

The study revealed that tucatinib in combination reduced patient’s risk of death by just over a third (34%), and of disease progression or death by 46%, compared with trastuzumab and capecitabine alone. Overall survival was prolonged by 4.5 months compared to the control group. The study also revealed that, for patients with brain metastases, this combination reduced disease progression and risk of death by more than half (52%) and extended overall survival by 6 months.

NICE’s recommendation follows the Scottish Medicines Consortium (SMC) acceptance of this treatment for use in NHS Scotland in January. Around 400 patients are expected to benefit from the drug annually in England and Wales.

Dr Alicia Okines, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and team leader for the Breast Cancer Systemic Therapy Trials team at the Institute of Cancer Research, London said:

“Although there have been many advances in breast cancer treatment over the years, women living with HER2-positive secondary breast cancer currently have few treatment options, particularly once they’ve received two lines of other targeted therapies, such as trastuzumab. For those whose cancer has spread to the brain, which is about half of this patient group, choices are even more restricted due to challenges with treating the brain. For example, the brain can only tolerate limited amounts of radiotherapy and many chemotherapies are unable to reach it effectively.

“Today’s approval means that there is a new targeted treatment combination for women living with HER2 positive secondary breast cancer whose cancers have worsened, despite standard treatment with other targeted therapies. This is absolutely wonderful news as the drug combination can help control the cancer for longer and extend lives, including for patients with brain metastases.”

Accountant Vicki McGinn, 44 from Chelmsford, was diagnosed with secondary breast cancer in 2017 and was initially treated with chemotherapy and targeted treatments. After the disease spread to her brain in October 2018, Vicki joined the HER2CLIMB trial at The Royal Marsden and, three years on, her disease is stable. She said:

“When I found out I had brain metastases, I wasn’t in a good way physically or emotionally. I had lost a lot of weight and was rapidly running out of treatment options too, which was frightening, and I felt like I was running out of time. You hear so many scary stories about what happens when cancer reaches the brain as it’s much harder to treat and how quickly it can deteriorate. I have lost so many friends to breast cancer in recent years.

“Being accepted onto this trial at The Royal Marsden was such a relief. Throughout, my team at this world-class hospital have been amazing and the treatment has meant three years of life I didn’t think I’d have. With this time, I’ve had the chance to create more memories and, as the side effects are manageable, I can live a fairly normal life, even working part-time.

“I think it’s fantastic this drug combination is being made available for more women with secondary HER2+ breast cancer, particularly those with brain metastases who have limited choices. It’s been a wonder drug for me, and I hope it will be successful for many other women too.”

The HER2CLIMB study was funded by Seagen.