Camrelizumab in combination with apatinib in patients with advanced hepatocellular carcinoma (RESCUE): a non-randomized, open-label, phase 2 trial
Mené sur 190 patients atteints d'un carcinome hépatocellulaire de stade avancé, cet essai non randomisé de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du camrélizumab combiné à l'apatinib, en traitement de première ou de deuxième ligne
Purpose: We assessed the efficacy and safety of camrelizumab (an anti-PD-1 monoclonal antibody) plus apatinib (a vascular endothelial growth factor [VEGFR]-2 tyrosine kinase inhibitor) in patients with advanced hepatocellular carcinoma (HCC). Patients and Methods: This non-randomized, open-label, multicenter, phase 2 study enrolled patients with advanced HCC who were treatment-naive or refractory/intolerant to first-line targeted therapy. Patients received intravenous camrelizumab 200 mg (for bodyweight ≥50 kg) or 3 mg/kg (for bodyweight <50 kg) every 2 weeks plus oral apatinib 250 mg daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC) per RECIST v1.1. Results: Seventy patients in the first-line setting and 120 patients in the second-line setting were enrolled. As of January 10, 2020, the ORR was 34.3% (24/70, 95% CI 23.3-46.6) in the first-line and 22.5% (27/120, 95% CI 15.4-31.0) in the second-line cohort per IRC. Median progression-free survival in both cohorts was 5.7 months (95% CI 5.4-7.4) and 5.5 months (95% CI 3.7-5.6), respectively. The 12-month survival rate was 74.7% (95% CI 62.5-83.5) and 68.2% (95% CI 59.0-75.7), respectively. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 147 (77.4%) of 190 patients, with the most common being hypertension (34.2%). Serious TRAEs occurred in 55 (28.9%) patients. Two (1.1%) treatment-related deaths occurred. Conclusion: Camrelizumab combined with apatinib showed promising efficacy and manageable safety in patients with advanced HCC in both the first-line and second-line setting. It might represent a novel treatment option for these patients.