Pembrolizumab (Keytruda; Merck) has been approved by the Food and Drug Administration (FDA) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This approval converts the prior accelerated approval in second-line treatment of metastatic NSCLC patients to regular approval. 

The new label additions state specific indications for:

Patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

And; patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab. 

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The approval marks the first checkpoint inhibitor to be approved for first-line treatment of lung cancer. It is based on two randomized, control trials. One trial, which included 305 patients with no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, demonstrated that those who received pembrolizumab (200mg every 3 233ks) had a median progression-free survival (PFS) of 10.3 months vs 6 months for those receiving platinum-based chemotherapy (HR 0.50, 95% CI: 0.37, 0.68; P<0.001).

A three-arm trial of 1033 patients previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, found that those randomized to pembrolizumab 2mg/kg every 3 weeks (HR 0.71, 95% CI: 0.58, 0.88; P<0.001) or pembrolizumab 10mg/kg every 3 weeks (HR 0.61, 95% CI: 0.49, 0.75; P<0.001) had an improved overall survival compared with patients receiving docetaxel. Median survival was 10.4, 12.7, and 8.5 months for the pembrolizumab 2mg/kg arm, the pembrolizumab 10mg/kg arm, and the docetaxel arm, respectively.

Keytruda is also indicated for the treatment of patients with unresectable or metastatic melanoma as well as for recurrent or metastatic head and neck squamous cell carcinoma.

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