pharmafile | April 12, 2023 | News story | Business Services  

Daiichi Sankyo UK Limited and AstraZeneca UK Limited welcome the news that the Scottish Medicines Consortium (SMC) has accepted Enhertu®▼ (trastuzumab deruxtecan) for restricted use within NHS Scotland as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one prior anti-HER2-based regimen[1]. The acceptance will allow trastuzumab deruxtecan to be used earlier in the treatment pathway as another treatment option for patients living with metastatic HER2-positive breast cancer. Previously issued SMC advice for the use of trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens also remains valid.[2]


In Scotland, the impact of breast cancer is significant with 4,297 new cases diagnosed in women in 2020 alone.[3] It is the most commonly diagnosed cancer in women, with one in eight Scottish women developing it in their lifetime.1 It is also the second most common cause of cancer death in women, with around 1,000 people dying from the disease each year.[4] It is estimated one in five cases are HER2-positive.[5],[6]


“Today’s SMC acceptance is another significant milestone for the people in Scotland living with HER2-positive metastatic breast cancer,” said Jo Taylor from METUPUK, a charity for people living with metastatic breast cancer. “There is still a significant unmet need within metastatic breast cancer, and earlier treatment options, as well as equity of treatment across the whole of the UK for fair access, are crucial in tackling the disease burden.”


SMC advice is based on results from the pivotal DESTINY-Breast03 phase 3 trial in 524 randomised patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. Results from the first interim analysis of DESTINY-Breast03 (May 2021 data cut-off) showed that, at 12 months, the percentage of patients who were alive without disease progression, as assessed by blinded independent central review, was 75.8% (95% CI, 69.8 to 80.7) with trastuzumab deruxtecan compared with 34.1% (95% CI, 27.7 to 40.5) with trastuzumab emtansine; the hazard ratio for disease progression or death from any cause was 0.28 (95% CI, 0.22 to 0.37; P<0.001).[7] Investigator-assessed median PFS was 25.1 months with trastuzumab deruxtecan as compared with 7.2 months with trastuzumab emtansine (hazard ratio, 0.26; 95% CI, 0.20 to 0.35; P<0.001). At the second interim analysis for OS (July 2022 data cut-off), trastuzumab deruxtecan showed a statistically significant improvement in overall survival versus trastuzumab emtansine, reducing the risk of death by approximately 36% (hazard ratio 0.64; 95% CI 0.47–0.87]; p=0.0037).[8]


“We are pleased to have worked in partnership with the SMC, NHS Scotland and the breast cancer community to make trastuzumab deruxtecan available earlier in the treatment pathway for eligible patients in Scotland and will work hard to support clinicians in their efforts to improve the quality of care to patients,” said Haran Maheson, Vice President, Head of Oncology, Daiichi Sankyo UK.


“We are delighted with this decision by the SMC. Scotland is currently developing a new cancer strategy, and we look forward to partnering with the Scottish Government to set a new ambition for cancer. Part of that ambition must be for rapid access to innovate cancer treatments, empowering the SMC to continue making positive decisions for Scottish patients like the one we’ve seen today,” said Tom Keith-Roach, President, AstraZeneca UK.


The safety of trastuzumab deruxtecan, at the time of submission, was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of Enhertu® (5.4 mg/kg) in the DESTINY‑Breast03 trial.7 The most common adverse reactions (frequency ≥20%), including blood and lymphatic system disorders: platelet count decreased, white blood cell count decreased, anaemia, gastrointestinal disorders: nausea, vomiting, constipation, diarrhoea, general disorders: fatigue, headache, investigations: Neutrophil count decreased, metabolism and nutrition disorders: decreased appetite, weight decrease, skin and subcutaneous disorders: alopecia.  Of the 39 events (15%) of interstitial lung disease (inflammation of the lung), <1% were recorded as CTCAE grade 3 events. No grade 4 or grade 5 ILD or pneumonitis events were adjudicated as drug-related.8


In England, trastuzumab deruxtecan was accepted by the National Institute for Health and Care Excellence (NICE) for use within the Cancer Drugs Fund (CDF) in December 2022 as an option for treating HER2 positive unresectable or metastatic breast cancer after one or more anti-HER2 treatments in adults. Trastuzumab deruxtecan has also been accepted in Wales and Northern Ireland in line with the NICE recommendation.


For further information about trastuzumab deruxtecan, please refer to the summary of product characteristics.

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