NICE backs use of MSD's KEYTRUDA for triple-negative breast cancer


For the first time, patients in England with triple-negative breast cancer (TNBC) will be able to access immunotherapy at an earlier stage of their treatment journey, as Merck & Co/MSD's KEYTRUDA is granted the go-ahead for use in patients with high-risk early-stage or locally advanced TBNC. The National Institute for Health and Care Excellence (NICE) has recommended the use of KEYTRUDA (pembrolizumab) as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment after surgery, for adults with early TNBC, at high risk of recurrence, or locally advanced TNBC. NICE's decision was based on results from the randomised, double-blind, placebo-controlled KEYNOTE-522 trial, which evaluated the efficacy of pembrolizumab in combination with chemotherapy in 1,174 patients with newly diagnosed, previously untreated and non-metastatic TNBC. Trial results showed that pembrolizumab met both primary endpoints of event-free survival and pathological complete response. After a median follow-up of 39.1 months, pembrolizumab, in combination with chemotherapy, led to a statistically significant and clinically meaningful improvement in EFS compared with chemotherapy alone. TNBC is an aggressive cancer with a high recurrence rate and a low five-year survival rate compared to other cancer types. In the UK alone, the disease affects around 8,000 people each year. Given the high risk of recurrence, new treatment options for use in the earlier stages of the cancer pathway are needed to improve survival rates and provide more positive treatment outcomes for patients. "TNBC is an aggressive type of breast cancer that disproportionately impacts black people and those under 40. Previously, there was no immunotherapy treatment option available for people with early stage or locally advanced TNBC, creating an unmet need for these patients," said David Long, head of oncology at MSD UK. "I am delighted by NICE's decision to make the first immunotherapy for early stage TNBC available. This decision will hopefully enable patients to have a more positive treatment outcome. MSD is proud to lead the way for this under-served patient population." NICE's decision to recommend pembrolizumab for TNBC builds upon draft guidance published earlier this year, which opened the door for approximately 100 TNBC patients in England and Wales to access Merck & Co/MSD's Keytruda following lengthy debate over the cost effectiveness of the treatment. Moreover, in October, Scotland became the first country in the UK to back NHS funding for the use of Merck & Co/MSD's Keytruda in combination with Eisai's Lenvima as a treatment for advanced or recurrent endometrial cancer.