Keytruda now available for untreated metastatic lung cancer patients via Cancer Drugs Fund

Merck Sharp & Dohme’s (MSD) immunotherapy Keytruda (pembrolizumab) will now be available as a first-line treatment to patients with untreated advanced lung cancer in combination with chemotherapy in England via the Cancer Drugs Fund (CDF).

It has been recommended for this patient group, only if Keytruda is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses. MSD will also be required to provide Keytruda according to the managed access agreement it already has in place with NICE.

This follows prior approval from cost-effective watchdog NICE, which green-lit Keytruda for use in more than 3,000 non-small cell lung cancer (NSCLC) patients. At that point NICE gave Keytruda conditional approval through the CDF, which meant that the treatment had to prove itself to be valuable to NSCLC patients over a certain period of time.

However, Keytruda has proved to be cost-effective, with NICE's final appraisal determination (FAD) meaning the immunotherapy is confirmed as a mainstream treatment. Data and evidence reviewed from KEYNOTE-407, an ongoing phase 3 trial, which was collected under a managed access agreement with NICE, demonstrated that the Keytruda combination therapy extended the life of patients compared to chemotherapy alone.

NICE has however maintained that the clinical evidence is immature and maintains that the cost-effectiveness of Keytruda remains uncertain. In addition to this, the watchdog reported uncertainty around the Keytruda combination therapy meeting the criteria for being considered a life-extending treatment at the end of life in comparison to standard chemotherapy.

Despite these uncertainties, NICE ultimately concluded that these criteria had been met and that the Keytruda combination therapy is potentially cost-effective. The initial KEYNOTE-189 study, which backed the approval of Keytruda plus chemotherapy in first-line NSCLC therapy by NICE last year, showed that this combination reduced the risk of death by 50% compared to standard chemotherapy.

Meindert Boysen, director, NICE Centre for Health Technology Evaluation

“The committee heard from the patient experts that people with squamous non-small-cell lung cancer often have a poor quality of life, and that treatments that have the potential to extend life would be of great importance,” said Meindert Boysen, director of the NICE Centre for Health Technology Evaluation.

“Pembrolizumab combination therapy is a promising treatment option for these patients who currently have very few. We are therefore pleased to be able to use the flexibility provided by the Cancer Drugs Fund to recommend it while further data on its clinical effectiveness is collected,” he added.

As a result of this approval, Keytruda will be immediately available via the CDF, and the therapy will be an option for NHS patients suffering with untreated NSCLC. This will also allow more evidence to be collected by NICE to address any uncertainties regarding overall survival.

Keytruda is the leader of the PD-1/PD-L1 class in the treatment of NSCLC, with rival Tecentriq from Roche hoping to catch up in this indication following European approval this year.

However, Tecentriq is unlikely to be able to do so, with Evaluate Pharma forecasting that Keytruda will be the top-selling drug worldwide in 2024 at $17bn predicted product sales.

Louise Houson, UK managing director, MSD

“We are pleased that following this approval the majority of lung cancer patients now have access to some form of immunotherapy, including those patients with particularly hard to treat forms of this disease," said Louise Houson, UK managing director, MSD.

"We have, as ever, worked collaboratively with NHS England and NICE to ensure the value of pembrolizumab in combination with chemotherapy is recognised. Enabling access to the first immunotherapy/chemotherapy combination for this form of lung cancer in the first line setting will make a real difference to patients," she added.