Randomized Clinical Trial of Pembrolizumab Versus Chemotherapy for Previously Untreated Chinese Patients With PD-L1–Positive Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: KEYNOTE-042 China Study
Mené en Chine sur 262 patients atteints d'un cancer du poumon non à petites cellules PD-L1+ de stade localement avancé ou métastatique, cet essai randomisé compare l'efficacité, du point de vue de la survie globale, et la toxicité du pembrolizumab et d'une chimiothérapie de première ligne choisie par le médecin
Résumé en anglais
In the global KEYNOTE-042 study (Clinicaltrials.gov, NCT02220894), pembrolizumab significantly improved overall survival (OS) versus chemotherapy in patients with previously untreated programmed death ligand 1 (PD-L1)–positive locally advanced/metastatic non–small-cell lung cancer (NSCLC) without EGFR/ALK alterations. We present results from patients in KEYNOTE-042 enrolled from China in the global or extension study (NCT03850444; protocol identical to global study). Patients were randomized 1:1 (stratified by ECOG performance status 0 versus 1, squamous versus nonsquamous histology, and PD-L1 tumor proportion score [TPS] ≥50% versus 1%–49%) to 35 cycles of pembrolizumab 200 mg every 3 weeks (Q3W) or investigator’s choice of 4–6 cycles of carboplatin plus paclitaxel or pemetrexed Q3W with optional pemetrexed maintenance for nonsquamous tumors. Primary endpoints were OS in patients with PD-L1 TPS ≥50%, ≥20%, or ≥1%. 262 patients (pembrolizumab, n=128; chemotherapy, n=134) were enrolled from China. At data cutoff (February 21, 2020; median follow up, 33.0 [range, 25.6–41.9] months), pembrolizumab was shown to improve OS versus chemotherapy in patients with PD-L1 TPS ≥50% (hazard ratio [95% CI], 0.63 [0.43–0.94]), TPS ≥20% (0.66 [0.47–0.92]), and TPS ≥1% (0.67 [0.50–0.89]). Grade 3–5 treatment-related adverse events occurred less frequently with pembrolizumab versus chemotherapy (19.5% versus 68.8%). In 22 patients who completed 35 cycles of pembrolizumab, ORR was 77.3% and median DOR was 27.6 months. Consistent with the global KEYNOTE-042 study, pembrolizumab improved OS versus chemotherapy in this study of Chinese patients with locally advanced/metastatic NSCLC and PD-L1 TPS ≥1%, supporting first-line pembrolizumab monotherapy for PD-L1–positive advanced/metastatic NSCLC in China.
