Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).
The approval was supported by data from the Phase 3 randomized, double-blind, multicenter, placebo-controlled KEYNOTE-407 trial. Study patients were randomized to either:
- Keytruda 200mg and carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8 and 15 of every 3-week cycle for 4 cycles, followed by Keytruda 200mg every 3 weeks (N=278); or
- Placebo and carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8 and 15 of every 3-week cycle for 4 cycles, followed by placebo every 3 weeks (N=281)
The primary efficacy outcome measures were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in patients receiving Keytruda + carboplatin and paclitaxel or nab-paclitaxel vs patients receiving placebo + carboplatin and paclitaxel or nab-pabclitaxel.
The data showed regardless of patients’ tumor PD-L1 expression status, Keytruda in combination with chemotherapy (carboplatin + paclitaxel or nab-paclitaxel) significantly improved OS, reducing the risk of death by 36% vs chemotherapy alone (hazard ratio [HR] 0.64, 95% CI, 0.49, 0.85; P =.0017). PFS was greater in the Keytruda arm vs placebo arm (6.4 months vs 4.8 months, HR 0.56, 95% CI, 0.45, 0.70; P <.0001).
In addition, ORR (among the first 204 patients enrolled) was greater in the Keytruda arm vs placebo arm (58% vs 35%; P =.0008).
Keytruda is the first anti-PD-1 regimen that is approved for first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status. It is now approved for first-line therapy in combination or as monotherapy for certain patients with metastatic NSCLC.
Keytruda is available as a 50mg/vial lyophilized powder for IV infusion, and as 25mg/mL solution for IV infusion.
For more information call (800) 672-6372 or visit Keytruda.com.