NICE Recommends MSD’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for Routine Commissioning for First-Line Treatment of Adults with Untreated Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)[1]

NICE Recommends MSD’s KEYTRUDA^® (pembrolizumab) in Combination with Chemotherapy for Routine Commissioning for First-Line Treatment of Adults with Untreated Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)[1]

LONDON, January 6, 2022 – Today, MSD (Merck Sharp & Dohme) (tradename of Merck & Co., Kenilworth, N.J., USA (NYSE:MRK)) is proud to announce that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends pembrolizumab when used in combination with carboplatin and paclitaxel as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults. This approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.

The decision makes pembrolizumab the first immunotherapy to be used routinely in the first line setting for metastatic squamous NSCLC regardless of PD-L1 expression, when combined with chemotherapy.

Dr Toby Talbot, consultant oncologist at Royal Cornwall Hospital, welcomed the news: “The combination of immunotherapy and chemotherapy used in this trial, which has now been commissioned for routine use on the NHS in England, is a major breakthrough for this subtype of lung cancer which until now has had few treatment options, poor prognosis and relatively little positive research compared to other forms of lung cancer. This treatment offers the hope of enhanced life expectancy compared to previous standard treatments.”

The recommendation is based on data from the Keynote 407 trial (559 adults). The original analysis (2018) found that after a median follow-up of 7.8 months, the median overall survival was 15.9 months (95% confidence interval [CI], 13.2 to not reached) in the pembrolizumab-combination group and 11.3 months (95% CI, 9.5 to 14.8) in the placebo-combination group (hazard ratio for death, 0.64; 95% CI, 0.49 to 0.85; P<0.001). The overall survival benefit was consistent regardless of the level of PD-L1 expression. The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<0.001).[2] Immune-mediated adverse events and infusion reactions occurred in 28.8% of patients in the pembrolizumab-combination group and in 8.6% of patients in the placebo-combination group.2

NICE were also presented with a subsequent analysis (published in 2020) that found after follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to exhibit a clinically meaningful improvement over placebo plus chemotherapy in overall survival of 17.1 months [95% confidence interval (CI): 14.4‒19.9] versus 11.6 months [95% CI: 10.1‒13.7]; hazard ratio [HR], 0.71 [95% CI: 0.58‒0.88]) and progression-free survival of 8 months [95% CI: 6.3‒8.4] versus 5.1 months [95% CI: 4.3‒6.0]; HR, 0.57 [95% CI: 0.47‒0.69]).[3]

Lung cancer is the leading cause of cancer-related mortality in the UK and currently with only 16% of patients surviving the condition for five or more years in England and Wales. The survival rate of lung cancer has changed very little in the last 40 years from 3% to 5%.[4] Lung cancer is the third most common cancer in the UK, with more than 48,000 new cases diagnosed per year in the UK.[5] NSCLC is the most common type of the disease, accounting for more than 80% of cases[6] and approximately 25-30% of all lung cancers are squamous cell carcinomas.[7] There are usually no signs or symptoms in the early stages of lung cancer and between 72-76% of people are diagnosed at a late stage (stage III or IV) when the cancer has spread outside the lungs.[8]

Lorraine Dallas, Director of Prevention Information and Support at Roy Castle Lung Cancer Foundation, said: “From supporting patients throughout their lung cancer journey, we understand how devastating a lung cancer diagnosis is. That is why we welcome this treatment option. Having ways to manage their cancer and maintain their quality of life in the face of uncertainty is valuable.”

Pembrolizumab is a checkpoint inhibitor that targets PD-L1, MSD presented clinical-effectiveness results for the PD-L1 subgroups in its submission. Based on the further data collected during review in the Cancer Drugs Fund, NICE agreed that this may suggest pembrolizumab combination therapy was effective at increasing progression-free survival in all PD-L1 subgroups.2 Safety information included adverse events of grade 3 or higher occurred in 69.8% of the patients in the pembrolizumab-combination group and in 68.2% of the patients in the placebo-combination group. Discontinuation of treatment because of adverse events was more frequent in the pembrolizumab-combination group than in the placebo-combination group (13.3% vs. 6.4%).2

David Long, MSD UK’s Executive Director for Oncology added: “Lung cancer is the nation’s biggest cancer killer, and squamous cell carcinomas are particularly aggressive. We are pleased that further data from the Keynote 407 trial has demonstrated pembrolizumab in combination with chemotherapy can continue to make a positive impact for these patients.3 Following this approval, the majority of late-stage lung cancer patients now have routine access to immunotherapy; a significant step in a cancer that has not seen much progress for decades.”

For detailed information regarding pembrolizumab, please refer to the Summary of Product Characteristics, available online at

www.medicines.org.uk/emc/product/6947/smpc