43P Camrelizumab plus famitinib as first-line treatment in advanced NSCLC patients with PD-L1 TPS ≥1%: A report from a multicenter, open-label, phase II basket trial

The combination of immune-checkpoint inhibitors and antiangiogenic agents can modulate the microenvironment in a synergistic manner and represents a promising treatment option for NSCLC. The efficacy and safety of camrelizumab (an anti-PD-1 antibody) plus famitinib (a receptor tyrosine kinase inhibitor) as first-line therapy for advanced NSCLC with PD-L1 TPS ≥1% was explored in an open-label, multicenter, phase II basket trial. Eligible patients (pts) received camrelizumab (200 mg once every 3 weeks by intravenous infusion) plus oral famitinib (20 mg once daily). Primary endpoint was confirmed objective response rate (ORR) assessed by investigator per RECIST v1.1. Disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), overall survival (OS), 6-, 9-, 12-month OS rates and safety profile were secondary endpoints. Among all enrolled 41 pts, 21 (51.2%) had PD-L1 TPS 1–49% and 20 (48.8%) had PD-L1 TPS ≥50% per local laboratory testing. As of data cutoff on Jun 22, 2022, 22 (53.7%) pts had achieved a confirmed objective response. This combination regimen achieved an ORR of 53.7% (95% confidence interval [CI], 37.4–69.3), and the DCR was 92.7% (95% CI, 80.1–98.5). Median DoR had not been reached yet and the median TTR was 2.1 mos (range, 1.4–8.3). With the median follow-up duration of 12.5 mos (range, 1.0–24.2), the median PFS was 16.6 mos (95% CI, 8.3-NR), median OS was 20.4 mos (95% CI, 20.4-NR; data not mature), and the estimated 12-month OS rate was 76.8% (95% CI, 60.0–87.3), respectively. The most common ≥ grade 3 treatment-related adverse events were hypertension (22.0%), increased alanine aminotransferase (12.2%) and decreased neutrophil count (9.8%). One patient (2.4%) died from grade 5 hemoptysis, which the investigator considered possibly related to the study treatment. Camrelizumab plus famitinib exhibited encouraging antitumor activity in advanced NSCLC pts whose tumor expressed PD-L1 TPS ≥1% with an acceptable safety profile. In this patient population, this combination regimen might offer an alternative treatment strategy that deserves further investigation.