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KEYNOTE-042 study - 1st Line Pembrolizumab 5y OS

Oncologyme  /  Mar 27, 2023

First-line #pembrolizumab monotherapy continued to show durable superiority over chemotherapy after 5 years of follow-up in #PD-L1–positive, locally advanced/metastatic NSCLC without EGFR/ALK alterations and remains a standard of care according to updated results from the phase III KEYNOTE-042 study.

1,274 eligible patients with PD-L1 tumor proportion score (TPS) ≥ 1% were randomly assigned to receive pembrolizumab (200 mg once every 3 weeks for 35 cycles) or chemotherapy (carboplatin + paclitaxel or pemetrexed) for 4-6 cycles with optional maintenance pemetrexed or chemotherapy.

After median follow-up of 5 years, OS was superior with pembrolizumab regardless of PD-L1 TPS (HR for TPS ≥ 50% = 0.68; TPS ≥ 20% = 0.75; TPS ≥ 1% = 0.79), with estimated 5-year OS rates with pembrolizumab of 21.9%, 19.4%, and 16.6%, respectively. No new toxicities were identified.