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Keytruda cleared in Europe for lung cancer

New second-line indication for Merck’s drug puts it in direct competition with BMS’ Opdivo

MerckMerck & Co's PD-1 inhibitor Keytruda has added a new indication in Europe, getting a green light for use in non-small cell lung cancer (NSCLC) patients.

The European Commission has approved Keytruda (pembrolizumab) for second-line treatment after chemotherapy of patients with locally advanced or metastatic NSCLC whose tumours test positive for PD-L1 - one of the ligands that bind to PD-1.

The approval is based on the results of the KEYNOTE-010 study, which showed that the immuno-oncology treatment could improve overall survival in these patients compared to traditional chemotherapy regimens.

Merck - which is known as MSD outside the US - is competing in the PD-1 inhibitor category with Bristol-Myers Squibb, whose Opdivo (nivolumab) drug is currently ahead in the market in terms of sales.

Keytruda is already approved for melanoma in Europe and other world markets, as well as for second-line NSCLC therapy in the US, and has grown quickly since launch with sales of $563m in the first six months of this year.

Opdivo has a key advantage in NSCLC in that it is approved for all patients - regardless of PD-L1 status - as well as for renal cell carcinoma and classical Hodgkin's lymphoma. This is reflected in financial terms, with BMS reporting $1.54bn in sales for Opdivo in the first half of 2016.

Merck has long argued that because patient outcomes in the treatment of NSCLC are correlated with the extent to which PD-L1 is expressed on the tumour it is important to assess the status of this biomarker prior to initiating therapy with a PD-1 directed agent.

The company said recently that PD-L1 testing rates continue to increase with approximately two-thirds of physicians now testing to determine which patients are most likely to benefit from PD-1 directed therapy.

Meanwhile, Merck is also preparing for possible approvals in head and neck cancer - where it would compete with Roche's just-launched PD-L1 inhibitor Tecentriq (atezolizumab) - as well as for first-line NSCLC.

Article by
Phil Taylor

3rd August 2016

From: Regulatory



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