Merck Wins Yet Again With New Keytruda Approval

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Merck & Co. Inc. (NYSE: MRK) shares were up slightly on Wednesday after the pharma giant gave another key update for its Keytruda line. The firm announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

This approval was based on results from the KEYNOTE-407 trial. In the pivotal Phase 3 trial of patients regardless of tumor PD-L1 expression status, Keytruda in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival, reducing the risk of death by 36% compared to chemotherapy alone.

This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.

With this approval, all appropriate patients with metastatic squamous NSCLC and all appropriate patients with metastatic nonsquamous NSCLC and no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations are now eligible for a Keytruda-based regimen as their first-line treatment option.

Dr. Roger M. Perlmutter, president of Merck Research Laboratories, commented:

Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat. Approval by the FDA has the potential to mean that KEYTRUDA can be used to improve survival for more patients with this debilitating disease.

Shares of Merck were last seen up about 2% at $74.12 on Wednesday, in a 52-week range of $52.83 to $74.13. The consensus analyst price target is $78.89.