Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as monotherapy 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 metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

The expanded approval was based on data from the phase 3 randomized, multicenter, open-label, active-controlled KEYNOTE-042 trial (N=1274). Study patients were randomized to receive pembrolizumab 200mg IV every 3 weeks or investigator’s choice of a carboplatin-containing regimen with either pemetrexed or paclitaxel; treatment was continued until disease progression, unacceptable toxicity, or maximum 24 months.

The main efficacy outcome measure was overall survival (OS) in the subgroup of patients with TPS ≥50%, with ≥TPS 20%, and the overall population with TPS ≥1%. Treatment with pembrolizumab led to a statistically significant improvement in OS vs chemotherapy alone in all evaluated subgroups:

  • TPS ≥1% group: median OS was 16.7 months with pembrolizumab vs 12.1 months with chemotherapy (hazard ratio [HR], 0.81; 95% CI, 0.71-0.93; P=.0036)
  • TPS ≥20% group: median OS with pembrolizumab was 17.7 months vs 13 months with chemotherapy (HR 0.77; 95% CI, 0.64-0.92; P=.004)

Fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss were the most common adverse reactions associated with pembrolizumab therapy in the trial.

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Keytruda, an anti-PD-1 therapy, is already approved to treat various skin, lung, head and neck, urothelial, hematologic, gastrohepatic, and gynecologic cancers. “This expanded first-line indication now makes Keytruda monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate,” said Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories.

Keytruda is available as 50mg/vial strength lyophilized powder for IV infusion after reconstitution and as a 25m/gmL strength solution for IV infusion after dilution in single-use vials.

For more information call (800) 672-6372 or visit Keytruda.com.