FDA Approves Combination Therapy for Non-Small Cell Lung Cancer

The US Food and Drug Administration has approved pembrolizumab (Keytruda) in combination with pemetrexed and carboplatin for the treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression.

Pembrolizumab is administered intravenously at a fixed dose of 200 mg over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or if there are no signs of disease progression after 24 months of therapy. If administered with pemetrexed and carboplatin on the same day, patients should receive pembrolizumab first.
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The efficacy and safety of pembrolizumab was determined based on data from a clinical trial that included 123 previously untreated patients with metatastic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. Patients taking pembrolizumab with pemetrexed and carboplatin had an objective response rate (ORR) of 55%, which was nearly double the ORR of patients taking pemetrexed and carboplatin alone (ORR 29%). Duration of response was 93% in patients who received pembrolizumab with standard chemotherapy compared with 81% of patients who did not receive pembrolizumab with standard chemotherapy. In addition, progression-free survival was 13 months for patients who received pembrolizumab with standard chemotherapy compared with 8.9 months for patients who did not receive pembrolizumab with standard chemotherapy.

Common adverse events associated with pembrolizumab included pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. In addition, severe infusion-related reactions can occur, which can be life-threatening.

—Melissa Weiss

Reference:

FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression [press release]. Kenilworth, NJ. Merck Newsroom; May 10, 2017. http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-first-line-combin.