o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/480071/2016

EMEA/H/C/003820

EPAR summary for the public

Keytruda

pembrolizumab

This is a summary of the European public assessment report (EPAR) for Keytruda. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Keytruda.

For practical information about using Keytruda, patients should read the package leaflet or contact their doctor or pharmacist.

What is Keytruda and what is it used for?

Keytruda is a cancer medicine used to treat adults with:

•    melanoma, a skin cancer, which has spread to other parts of the body or cannot be surgically removed;

•    non-small cell lung cancer (NSCLC), which has spread nearby or to other parts of the body in patients who have previously been treated with at least one chemotherapy regimen. Keytruda is specifically for lung tumours that produce a protein known as PD-L1.

The medicine contains the active substance pembrolizumab.

How is Keytruda used?

Treatment with Keytruda must be started and supervised by a doctor experienced in the treatment of

cancer. The medicine can only be obtained with a prescription.

Keytruda is available as a powder that is made up into a solution for infusion (drip) into a vein. The

infusion is given at a recommended dose of 2 mg per kilogram body weight over 30 minutes every

three weeks. The doctor may need to delay doses if certain side effects occur, or stop treatment

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

altogether if side effects are severe. Treatment is continued until the disease gets worse or side effects become unmanageable.

For patients with lung cancer, doctors should test the tumours to check if the cancer cells produce the PD-L1 protein before starting treatment.

For further information, see the summary of product characteristics.

How does Keytruda work?

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Pembrolizumab has been designed to attach to and block a receptor called PD-1, which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells. By blocking PD-1, pembrolizumab prevents switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

What benefits of Keytruda have been shown in studies?

Keytruda has been shown to be effective in treating patients with melanoma and non-small cell lung cancer.

Early results from a study of 540 previously treated melanoma patients showed that 6 months after start of treatment, the disease had not worsened in 34% of patients treated with Keytruda compared with 16% of patients treated with chemotherapy.

A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab. Early results from this study showed that the patients treated with Keytruda lived for up to 5.5 months without their disease getting worse compared with 2.8 months with ipilimumab. The study also found that patients treated with Keytruda lived longer than patients who received ipilimumab. Up to 71% of patients lived for at least 12 months after start of their treatment compared with 58% of patients on ipilimumab.

A third study looked at around 1,000 patients with lung cancer who had had at least one previous chemotherapy treatment and whose tumours produced PD-L1. In patients whose tumours tested strongly for PD-L1, overall survival was higher after Keytruda treatment (around 15 months) than after treatment with another cancer medicine docetaxel (around 8 months). The period during which the disease did not get worse in this group of patients was also higher with Keytruda: around 5 months versus 4 months with docetaxel.

Keytruda was also effective in the larger group of patients with lung cancer, including those whose tumours were not strongly positive for PD-L1.

What are the risks associated with Keytruda?

The most common side effects with Keytruda (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), itching, rash, joint pain and tiredness, most of which are mild to moderate in severity. Other common side effects of Keytruda related to the activity of the immune system causing inflammation of body organs. Most will resolve following appropriate treatment or on stopping Keytruda.

For the full list of all side effects and restrictions with Keytruda, see the package leaflet.

Why is Keytruda approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda's benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma. The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable.

With respect to NSCLC, the CHMP noted that Keytruda helps prolong survival and slows the worsening of the disease. The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of docetaxel.

What measures are being taken to ensure the safe and effective use of Keytruda?

The company that makes Keytruda will provide educational packs for doctors who are expected to prescribe Keytruda containing information on how the medicine should be used and how to manage side effects, particularly side effects on the immune system. The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.

In addition, the company will provide the final results of the studies with Keytruda to confirm the longterm benefits of the medicine. Moreover, the company will further evaluate the 2 mg/kg and 10 mg/kg dose in specific patients and will also carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda have also been included in the summary of product characteristics and the package leaflet.

Other information about Keytruda

The European Commission granted a marketing authorisation valid throughout the European Union for Keytruda on 17 July 2015.

The full EPAR and risk management plan summary for Keytruda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Keytruda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2016.

Keytruda

EMA/480071/2016

Page 3/3