Pembrolizumab Combination for Metastatic NSCLC Upgraded to Full FDA Approval
FDA upgraded the approval of pembrolizumab in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic, nonsquamous NSCLC with no EGFR or ALK genomi
The US Food and Drug Administration (FDA) approved pembrolizumab plus pemetrexed and platinum chemotherapy in the first-line setting for the treatment of metastatic, non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, according to an FDA news release.
Pembrolizumab was previously granted accelerated approval expanding its label for this indication based on findings from the KEYNOTE-021 phase 2 study, which showed an improvement in overall survival (OS) and progression-free survival (PFS).
Full (regular) approval was granted based on evidence from the KEYNOTE-189 phase 3 study (ClinicalTrials.gov Identifier: NCT02578680), for which researchers enrolled 616 patients with NSCLC. Patients were randomly assigned to receive pembrolizumab or placebo plus pemetrexed and platinum chemotherapy.
Results from a prespecified interim analysis showed pembrolizumab led to significant improvements in survival outcomes. Patients in the pembrolizumab arm had a non-evaluable median OS compared with 11.3 months for patients who received placebo (hazard ratio, 0.49; 95% CI, 0.38-0.64; P <.00001), and the median PFS was 8.8 months in the pembrolizumab arm vs 4.9 months in the placebo arm (HR 0.52; 95% CI, 0.43-0.64; P <0.00001).
The overall response rates were 48% and 19% in the pembrolizumab and placebo arms, respectively (P <.0001), and the median duration of response was 11.2 months and 7.8 months, respectively.
Frequently reported adverse events — occurring in at least 20% of study patients — were nausea, vomiting, diarrhea, constipation, decreased appetite, cough, dyspnea, rash, pyrexia, and fatigue/asthenia.
- FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC [news release]. Silver Spring, MD: US Food and Drug Administration; August 20, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617471.htm. Accessed August 21, 2018.