European Commission approves lung cancer drug KEYTRUDA

Image of lungs to show Research into early signs of lung cancer spread

MSD has announced that the European Commission (EC) has granted KEYTRUDA® (pembrolizumab) a licence for use in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults who have no EGFR or ALK positive mutations.

Pembrolizumab plus pemetrexed and platinum-based chemotherapy reduces the risk of death by more than 50% compared to pemetrexed and platinum-based chemotherapy alone.

This decision makes pembrolizumab the first immunotherapy to be approved by the EC for treatment of NSCLC in combination with chemotherapy and is based on the KEYNOTE-189 clinical trial, which looked at the treatment in patients who were non, low and high expressors of the PD-L1 biomarker.

In the KEYNOTE-189 study a 51% reduction in the risk of death was observed in patients with non-squamous NSCLC who were treated with pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) compared to pemetrexed and platinum-based chemotherapy alone. A reduction in the risk of disease progression or death of 48% was also observed with pembrolizumab in combination with pemetrexed and platinum-based chemotherapy.

Each year, more people die of lung cancer worldwide than from colon, breast, and prostate cancers combined. Lung cancer is also the third most common cancer in the UK with around 44,500 people diagnosed with the condition every year. The UK has the second worse survival rate for lung cancer in Europe with only 8% of patients surviving more than 5 years.

Gary Middleton, Professor of Medical Oncology at the University of Birmingham said, “This decision is likely to bring a step change in the way we treat lung cancer. It opens up treatment with pembrolizumab to anyone with non-squamous, non-small cell lung cancer, the most common type of lung cancer, that has spread to other parts of the body. Since the arrival of immunotherapies there has been tremendous progress in the treatment of lung cancer.”

Vanessa Beattie, Chair, National Lung Cancer Forum for Nurses and Clinical Nurse Specialist, Aintree University Hospital said, “It is such a tough condition which can be missed until it is at an advanced stage and very few options are left, beyond palliative care. By combining immunotherapies with chemotherapy we are seeing remarkable benefits for patients, without adding a similar level of side-effects seen with chemotherapy on its own.”

Louise Houson, Managing Director, MSD UK & Ireland, said, “Lung cancer remains an area of great unmet need and it takes too many lives each year. We look forward to combining our inventive science with the work of healthcare professionals up and down the country so that, together, we can renew our efforts to reach the best possible outcomes for everyone affected by lung cancer.”