FDA Approves Pembrolizumab for PD-L1-expressing Metastatic NSCLC

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The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with metastatic NSCLC whose tumors express PD-L1.
The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with metastatic NSCLC whose tumors express PD-L1.

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.1

The FDA approval added the following 2 indications for pembrolizumab:

  • 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.
  • 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.

This current approval converts the prior accelerated approval in second-line treatment of patients with metastatic NSCLC to regular approval and expands the indication in second-line treatment to include all patients with PD-L1-expressing NSCLC. It is also the first FDA approval of a checkpoint inhibitor for the frontline treatment of lung cancer.

Approval was based on findings from 2 clinical trials that demonstrated that treatment with pembrolizumab significantly prolonged progression-free survival and overall survival compared with chemotherapy in patients with metastatic NSCLC.

In a trial of 305 treatment-naive patients with a TPS greater than or equal to 50%, pembrolizumab was associated with a 50% reduced risk of progression or death (hazard ratio [HR], 0.50; 95% CI, 0.37-0.68; P < .001) and a 40% reduction in the risk of mortality vs chemotherapy (HR, 0.60; 95% CI, 0.41-0.89; P < .005).

In a 3-arm trial of 1033 previously treated patients with a TPS greater than or equal to 1%, pembrolizumab 2 mg/kg every 3 weeks reduced the risk of death by 29% compared with docetaxel (HR, 0.71; 95% CI, 0.58-0.88; P < .001) and pembrolizumab 10 mg/kg every 3 weeks was associated with a 39% reduction in the risk of death vs chemotherapy (HR, 0.61; 95% CI, 0.49-0.75; P < .001).

RELATED: FDA Grants Priority Review to Pembrolizumab for Frontline Treatment of NSCLC

The most common adverse events with pembrolizumab among patients with metastatic NSCLC were decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Clinicians should be aware that pembrolizumab may cause immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

The recommended dose and schedule of pembrolizumab for patients with NSCLC is 200 mg intravenously over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months among patients without disease progression.

Reference

  1. Pembrolizumab (Keytruda) checkpoint inhibitor. U.S. Food and Drug Administration approved drugs website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm526430.htm. Updated October 24, 2016. Accessed October 25, 2016.

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