MSD’s Keytruda (pembrolizumab) has been recommended by the National Institute for Health and Care Excellence (NICE), as announced by the company.

The organisation has issued a final appraisal determination (FAD) that recommends the cancer blockbuster in the Cancer Drugs Fund (CDF) when used in combination with carboplatin and paclitaxel as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults.

NICE warns, however, that it is only recommended if the treatment is stopped at two years of uninterrupted treatment, or earlier if disease progresses, and the company provides the drug according to the managed access agreement.

The decision means that Keytruda is the first immunotherapy to be used in the first line setting for metastatic squamous NSCLC regardless of PD-L1 expression, when combined with chemotherapy. The drug in combination with carboplatin and either paclitaxel or nab- paclitaxel is already indicated for the first-line treatment of metastatic squamous NSCLC in adults.

NICE says that the recommendation was supported by data from the Phase III KEYNOTE-407 trial, which found that drug significantly improved overall survival (OS) in adults with metastatic squamous NSCLC regardless of PD-L1 tumour expression status by 15.9 months, compared to 11.3 months.

It also reduced the risk of death by over a third (36%) compared to chemotherapy alone.

Professor Gary Middleton, Professor of medical oncology at the University of Birmingham said that it is “of great and lasting importance that we will now be able to offer patients with advanced squamous NSCLC the combination of chemotherapy plus Keytruda as a first line treatment option.”

He continued, “Progress in the first line treatment of this cancer has been frustratingly slow and, until this time, there has not been any agent which, when added to chemotherapy, provides really robust and clinically meaningful benefits over chemotherapy alone.

“The addition of pembrolizumab significantly improves overall survival compared to chemotherapy alone and, importantly, across all strata of tumour cell PD-L1 expression. The combination of pembrolizumab and chemotherapy in eligible patients with advanced squamous NSCLC should now become the first line standard of care and the benchmark for future first line studies in this disease.”

Lung cancer is the leading cause of cancer-related mortality in the UK and currently only 5% of patients surviving the condition for ten or more years in England and Wales.