What is the efficacy of pembrolizumab for the treatment of metastatic non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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First-line combination treatment of pembrolizumab was approved in May 2017 for metastatic nonsquamous NSCLC. Approval was based on data from the KEYNOTE-021 trial (Cohort G1) in 123 previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations and irrespective of PD-L1 expression. In this trial, pembrolizumab plus pemetrexed and carboplatin demonstrated an ORR that was nearly double the ORR of pemetrexed/carboplatin (55% vs 29% respectively; all responses were partial responses). Among patients who received pembrolizumab plus pemetrexed/carboplatin, 93% had a duration of response of 6 months or more (range 1.4+ to 13.0+ months) compared to 81% who received pemetrexed/carboplatin alone (range 1.4+ to 15.2+ months). Progression free survival also improved (median 13.0 months [95% CI]) compared to 8.9 months (95% CI) with pemetrexed/carboplatin alone. [195]

In the KEYNOTE-010 trial, pembrolizumab was compared with docetaxel in 1034 patients with previously treated NSCLC who had PD-L1 expression on at least 1% of tumor cells, pembrolizumab resulted in longer overall survival and had a more favorable benefit-to-risk profile. In this randomized, open-label trial, median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with pembrolizumab 10 mg/kg, and 8.5 months with docetaxel. [196]

In the KEYNOTE-189 trial, the addition of pembrolizumab to standard chemotherapy with pemetrexed and a platinum-based agent resulted in significantly longer overall and progression-free survival. Metastatic nonsquamous NSCLC patients (n=616) with no EGFR or ALK and no previous treatment received pemetrexed and a platinum-based drug with either pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. [197]

Approval for treatment of metastatic squamous NSCLC with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel was supported by the KEYNOTE-407 study. The combination of pembrolizumab plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel) significantly improved overall survival (OS) compared with chemotherapy alone, at a median of 15.9 months compared with 11.3 months (hazard ratio [HR], 0.64; P = 0.0017). [171]

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