• KEYTRUDA® combination significantly improved overall survival in adults with metastatic squamous NSCLC
   
• Its safety in combination with chemotherapy was evaluated in 791 NSCLC patients in clinical studies

Merck has recently announced that its anti-PD-1 immunotherapy KEYTRUDA® has won approval from the European Commission (EC), for use in combination with paclitaxel or nab-paclitaxel and carboplatin in first-line treatment of adult patients having metastatic squamous non-small cell lung cancer (NSCLC).

EC’s approval was apparently based on the data from the Phase 3 KEYNOTE-407 trial, which showed that KEYTRUDA® helped in significantly improving overall survival (OS) in adults with metastatic squamous NSCLC, in combination with chemotherapy, irrespective of the status of PD-L1 tumor expression. It reduced the risk of death by 36% when compared to treatment using chemotherapy alone.

Merck informed that the safety of KEYTRUDA® in combination with chemotherapy was evaluated in 791 NSCLC patients, who received 200mg, 2mg/kg or 10mg/kg KEYTRUDA® every 3 weeks during clinical studies. This approval allows the marketing of the KEYTRUDA® combination across all 28 European Union member countries as well Iceland, Norway and Lichtenstein, at the approved dose of 200mg every 3 weeks until progression of disease or unacceptable toxicity.

To treat NSCLC, KEYTRUDA® is also approved in Europe as the first-line treatment of metastatic squamous or non-squamous NSCLC as monotherapy in adults with high PD-L1 tumor expression and no ALK or EGFR positive tumor mutations. It can also be deployed as a first-line treatment, in combination with pemetrexed and platinum chemotherapy, for metastatic non-squamous NSCLC in adults with no ALK or EGFR positive mutations in tumors.

Further, KEYTRUDA® has also been approved in the region for treating locally advanced or metastatic NSCLC in adult patients whose tumors express PD-L1 and also who have received at least one chemotherapy regiment previously.

Across the patient population in clinical studies, Merck said the most frequent adverse reactions observed were anemia, constipation, decreased appetite, diarrhea, fatigue, nausea and neutropenia. Occurrence of Grade 3-5 adverse reactions were 67%, while for chemotherapy alone they were 66%.