Merck & Co’s – known as MSD outside the US and Canada – Keytruda (pembrolizumab) has been recommended by the National Institute of Health and Care Excellence (NICE) to treat resectable non-small cell lung cancer (NSCLC) in adults at a high risk of disease recurrence.
The anti-PD-1 therapy has been specifically recommended for use in combination with platinum-based chemotherapy as a neoadjuvant treatment before surgery and then as a monotherapy in the adjuvant setting after surgery.
Lung cancer is the third most common cancer in the UK and NSCLC accounts for approximately 90% of all cases.
While surgery is successful for many patients with early stages of the disease, recurrence is common and the five-year survival in the UK is generally below the European average.
Administered as an intravenous infusion, Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells.
More than 5,000 patients in England are expected to be eligible for the therapy following NICE’s latest recommendation, which was supported by positive results from the phase 3 KEYNOTE-671 trial.
In the study, the Keytruda regimen was associated with significant improvements in event-free survival, major pathological response, pathological complete response and overall survival compared to placebo in patients with previously untreated, resectable NSCLC.
Benson Fayehun, head of oncology at MSD UK, said: “Lung cancer is the third largest cancer in the UK and as such affects many lives. [The company] is proud to share that patients now have access to a new treatment option in early-stage lung cancer… We are grateful for our collaboration with NICE and NHS England to make this possible.”
Also commenting on the recommendation, Toby Talbot, consultant clinical oncologist at Royal Cornwall Hospitals, said: “This newly reimbursed treatment has been shown to reduce risk of cancer relapse following surgery and will be a valuable additional treatment for patients being treated for lung cancer.”
The positive opinion comes just one week after Keytruda was approved by the Medicines and Healthcare products Regulatory Agency in combination with Astellas/Pfizer’s Padcev (enfortumab vedotin) as a first-line treatment for advanced bladder cancer.
The UK regulator’s decision applies to adults with unresectable or metastatic urothelial carcinoma who are eligible for platinum-containing chemotherapy.