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Keytruda adds another NSCLC approval in Europe

Squamous NSCLC completes first-line dominance


The European Commission has granted MSD's Keytruda approval in another major lung cancer setting.

In combination with chemotherapy, the anti-PD-1 therapy has been approved as a first-line medicine for those with metastatic squamous non-small cell lung cancer (NSCLC).

NSCLC is an area that is familiar to MSD with Keytruda after it established itself as the new standard of care, but most of its lung cancer indications are based in the nonsquamous NSCLC area, which is the most common subtype of NSCLC accounting for 40% of all lung cancers.

Squamous NSCLC on the other hand accounts for around 30% of all lung cancers, and effective lung cancer therapies based on oncogenic drivers such as mutations in the epidermal growth factor receptor (EGFR) kinase and fusions involving anaplastic lymphoma kinase (ALK) are mostly absent in squamous tissue structure.

As a result, not many patients with squamous NSCLC can benefit from those types of treatments.

“Keytruda provides a foundation for the treatment of lung cancer in Europe, and this approval expands our first-line combination indications to include adults with metastatic squamous non-small cell lung cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“This is a meaningful treatment advance as an anti-PD-1 combination therapy is now approved in Europe for this type of non-small cell lung cancer. With this approval, more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with KEYTRUDA.”

The approval is based on data from KEYNOTE-407, a Phase 3 study evaluating Keytruda in combination with chemotherapy compared with chemotherapy alone.

It was found that Keytruda plus chemotherapy reduced the risk of death by 36% in those with squamous NSCLC, compared to chemotherapy alone.

The treatment has also seen recent success as a monotherapy in locally advanced or metastatic non-squamous or squamous non-small cell lung cancer NSCLC patients with low PD-L1 expression.

It should a significant improvement in overall survival compared with chemotherapy – 16.7 months versus 12.1 months and if approved, it could potentially rule out the use of chemotherapy in this subset of patients.

MSD/Merck & Co are expecting a result from the FDA by 11 April.

Keytruda's closest competitor in first line NSCLC treatment is Roche's Tecentriq, which recently gained EU approval for frontline combination use in non-squamous NSCLC, but it trails far behind Keytruda in revenues and market share.

Article by
Gemma Jones

15th March 2019

From: Regulatory



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