Phase III study of ramucirumab plus docetaxel versus atezolizumab for previously treated PD-L1 low or negative advanced non-small-cell lung cancer: WJOG10317L study
Mené sur 70 patients atteints d'un cancer du poumon non à petites cellules ne surexprimant pas PD-L1 ou faiblement, et de stade avancé (durée médiane de suivi : 24,2 mois), cet essai de phase III compare l'efficacité, du point de vue de la survie globale, et la toxicité de 2 traitements de deuxième ligne, l'un par atézolizumab et l'autre par docétaxel/ramucirumab
Purpose: We aimed to compare the efficacy and safety of docetaxel plus ramucirumab and atezolizumab as second-line treatment for programmed death-ligand 1 (PD-L1)-negative or low advanced non-small-cell-lung cancer (NSCLC) after platinum-based chemotherapy.
Patients and methods: This multicenter randomized phase III study enrolled patients with advanced NSCLC who had progressed during or after first-line platinum-based chemotherapy. Patients were allocated randomly (1:1) to receive atezolizumab (arm A) or docetaxel plus ramucirumab (arm B) every 3 weeks. The primary endpoint was overall survival (OS).
Results: This study was activated in April 2018 and closed in March 2020 due to slow accrual. Seventy eligible patients were enrolled from 26 institutions, including 36 patients in arm A and 34 in arm B. The median OS (median follow-up, 24.2 months) were 17.1 and 15.8 months (HR = 1.508, 95 % confidence interval (CI), 0.86–2.65; P = 0.23), respectively. The 2-year OS rates were 42.8 % (95 % CI, 26.2 %–58.4 %) and 19.4 % (95 %CI, 7.5–35.3), the objective response rates (ORRs) were 5.6 % and 35.3 % (P = 0.002), and the median progression-free survival (PFS) were 1.5 and 5.5 months (P = 0.005), respectively. The crossover rates were 55.6 % and 64.7 %, and the median times from randomization to progression or death post-crossover were 12.9 and 9.1 months. Grade ≥ 3 toxicities included neutropenia (2.8 %/17.6 %), thrombocytopenia (2.8 %/8.8 %), anorexia (2.8 %/5.9 %), febrile neutropenia (0 %/5.9 %), and hypertension (2.8 %/8.8 %).
Conclusions: OS was similar in both arms, but docetaxel plus ramucirumab resulted in favorable ORR and PFS. The 2-year OS rates suggested that atezolizumab might enhance the efficacy of post-study cytotoxic chemotherapy; however, interpretation of the data was limited by the small sample size.
Lung Cancer , résumé, 2025