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FDA Expands Pembrolizumab Indication in First-Line Treatment of NSCLC

By: Sarah Jackson
Posted: Friday, April 12, 2019

Yesterday, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or of those with metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (tumor proportion score ≥ 1%), as determined by an FDA-approved test. Pembrolizumab was previously approved as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥ 50%).

Approval was based on KEYNOTE‑042 (ClinicalTrials.gov identifier NCT02220894), a randomized, multicenter, open-label, active-controlled trial conducted in 1,274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumors expressed PD-L1 (TPS ≥ 1%). Overall survival in the TPS ≥ 50% NSCLC subgroup, the TPS ≥ 20% NSCLC subgroup, and the overall population (TPS ≥ 1%) were the major efficacy measures. The trial demonstrated statistically significant improvement in overall survival for those who received pembrolizumab compared with chemotherapy in all three populations.

The most common adverse reactions reported in at least 10% of patients who received pembrolizumab as a single agent in KEYNOTE-042 included fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.



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