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Merck withdraws European application for Keytruda in first-line NSCLC

PBR Staff Writer Published 30 October 2017

Merck has withdrawn its European application seeking approval of its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin (pem/carbo) in Europe as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC).

The company did not reveal the exact reason behind the withdrawal of the Marketing Authorisation Application (MAA) of the Keytruda combination.

However, the company's move is due to an outcome of discussions with the European regulatory authorities as per a report in BioCentury which has cited Merck spokesperson Pamela Eisele.

Merck’s application was based on the results of the KEYNOTE-021, Cohort G clinical trial. In this study, the drug combination regimen showed considerable improvements in overall response rate (ORR) and progression-free survival (PFS) in comparison to chemotherapy alone.

The company says that its broad clinical development program has a number of studies assessing Keytruda in combination with chemotherapy in the first-line NSCLC setting.

It plans to share data from these studies with regulatory authorities and the medical community when they are ready.

Merck’s withdrawal of its European application comes despite securing an approval for the Keytruda combination regimen from the US Food and Drug Administration (FDA) in May for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.

According to Merck, Keytruda injection 100mg works by boosting the immune system’s ability to help identify and fight tumor cells.

The anti-PD-1 therapy is a humanized monoclonal antibody which prevents the interaction between PD-1 and its ligands, PD-L1 and PD-L2. As a result, it activates T lymphocytes which may impact tumor cells and also healthy cells.


Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.