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EMA Does Not Recommend Extending the Use of Pembrolizumab

Application concerned first-line treatment in patients with NSCLC and PD-L1 scores between 1 and 49%
11 May 2020
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours

On 30 April 2020, the European Medicines Agency (EMA) announced that it has finalised its assessment of an application for the use of pembrolizumab (Keytruda) alone as a first-line treatment in patients with non-small cell lung cancer (NSCLC) and low levels of the protein PD-L1 (scores between 1 and 49%).

Currently pembrolizumab is only used alone as first-line treatment in patients with NSCLC and high levels of PD-L1 (scores of 50% and above).

Although EMA’s Committee for Medicinal Products for Human Use (CHMP) did not recommend extending the use of Keytruda, it recommended that study data from the application be included in the medicine’s product information.

Keytruda is a cancer medicine used to treat melanoma, NSCLC, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma, and renal cell carcinoma.

For NSCLC, Keytruda on its own can be used as a first-line treatment in patients whose tumours produce high levels of the PD-L1 protein (scores of 50% and above).

It contains the active substance pembrolizumab and is given as an infusion into a vein.

Merck Sharp & Dohme B.V. applied to extend the use of Keytruda alone and as a first-line treatment in patients who have NSCLC with lower levels of PD-L1 (scores between 1 and 49%).

The company presented results from a main study in 1,274 previously untreated patients with NSCLC that had PD-L1 scores of 1% and above. The study compared Keytruda on its own with chemotherapy consisted of carboplatin with paclitaxel or pemetrexed and looked at overall survival.

The CHMP noted that although the main study showed that Keytruda was effective when used alone as a first-line treatment in NSCLC patients with protein scores of 1% and above, the benefits were mainly seen in patients with higher levels of PD-L1. When patients with lower levels of PD-L1 were looked at separately, the results were inconclusive. For these reasons, the committee was of the opinion that the extension should not be granted.

In addition, the CHMP noted that a higher number of patients given Keytruda alone died early compared with those given chemotherapy, although a higher number of Keytruda patients also survived for longer.

The data from the main study will be included in the product information for Keytruda so that healthcare professionals have access to most up to date data on the effects of Keytruda in patients with NSCLC.

The company informed the Agency that there is no impact on patients in ongoing clinical trials or compassionate use programmes.

There are no consequences for Keytruda in its authorised uses.

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