The US Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) as a first-line treatment options for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 without EGFR or ALK mutations.

PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1, such as Keytruda and Opdivo, may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in advanced lung cancer. Both Keytruda and Opdivo are approved in the U.S. to treat lung-cancer patients whose disease has progressed after prior chemotherapy treatment and for some other tumors.  With this new indication, Keytruda is now the only anti-PD-1 therapy to be approved as a first-line treatment in advanced NSCLC.

The expanded approval of Keytruda is based on recent study [KEYNOTE-024] results indicating an improvement in progression-free survival and overall survival with Keytruda compared to chemotherapy in patients whose tumors express high levels of PD-L1.2  In this study, Keytruda reduced the risk of progression or death by 50% compared to chemotherapy.

With this new option for treatment-naïve metastatic NSCLC patients, early testing of PD-L1 expression will be important.


  1. MERCK press release, accessed 10/25
  2. Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1–positive non–small-cell lung cancer. N Engl J Med.DOI: 10.1056/NEJMoa1606774

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