KEYNOTE-042: Pembrolizumab Improved Overall Survival in Non-Small Cell Lung Cancer
The improvement was seen in patients with previously untreated advanced/metastatic NSCLC without EGFR or ALK mutations and PD-L1 TPS 1% or more compared with platinum-based chemotherapy.
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CHICAGO—Pembrolizumab led to superior overall survival (OS) among patients with previously untreated advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR or ALK mutations and PD-L1 tumor proportion score (TPS) greater than or equal to 1% over platinum-based chemotherapy regimens, according to data presented during the Plenary Session at the American Society of Clinical Oncology 2018 Annual Meeting on Sunday, June 3.1
Data from the KEYNOTE-024 study previously demonstrated that first-line pembrolizumab therapy led to significantly prolonged progression-free survival (PFS) and OS among patients with metastatic NSCLC. Study participants had no targetable alterations and a PD-L1 TPS greater than or equal to 50% in KEYNOTE-024, but in KEYNOTE-042 (ClinicalTrials.gov Identifier: NCT02220894), authors evaluated the efficacy of pembrolizumab among patients with lower TPS of 1% or more.
In this phase 3 study, researchers randomly assigned 1274 patients to receive pembrolizumab 200 mg every 3 weeks or investigator's choice chemotherapy, including: paclitaxel plus carboplatin, or pemetrexed plus carboplatin with optional pemetrexed maintenance therapy for nonsquamous histology only.
Overall, 637 patients were assigned to each arm and 47.0% (599) and 64.2% (818) had TPS greater than or equal to 50% and greater than or equal to 20%, respectively. The median follow-up was 12.8 months.
At the time of analysis, 13.7% of patients in the pembrolizumab arm were continuing therapy versus 4.9% of patients who were receiving pemetrexed maintenance therapy.
OS was significantly improved among patients with TPS 50% or more treated with pembrolizumab with 20.0 months compared with 12.2 months among patients who received chemotherapy (hazard ratio [HR], 0.69; 95% CI, 0.56-0.85; P = .0003). Among patients with TPS 20% or more, pembrolizumab led to OS of 17.7 months versus 13.0 months in the chemotherapy arm (HR, 0.77; 95% CI, 0.64-0.92; P = .0020). Among patients with TPS 1% or more, patients in the pembrolizumab arm had an OS of 16.7 months compared with 12.1 months among patients treated with chemotherapy (HR, 0.81; 95% CI, 0.71-0.93; P = .0018).
Moreover, patients receiving pembrolizumab experienced a lower rate of treatment-related grade 3 to 5 adverse events compared with chemotherapy (17.8% vs 41.0%).
PFS outcomes are still under investigation.
The authors concluded that “these data confirm and potentially extend the role of pembrolizumab monotherapy as a standard first-line treatment for PD-L1-expressing advanced/metastatic NSCLC.”
Read more of Cancer Therapy Advisor's coverage of the American Society of Clinical Oncology (ASCO) 2018 meeting by visiting the conference page.
- Lopes G, Wu YL, Kudaba I, et al. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: Open-label, phase 3 KEYNOTE-042 study. Late breaking abstract presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.