74P Five-year survival outcomes of camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic NSCLC: A phase II study

In an open-label, single-arm, multicenter phase II study, camrelizumab demonstrated promising efficacy as a second-line treatment in pre-treated advanced/metastatic NSCLC, with those exhibiting positive PD-L1 expression deriving greater benefit from camrelizumab (Yang et al., Cancer Immunol Immunother, 2021). Here we present an updated analysis of efficacy and safety outcomes from this study with a follow-up period of approximately 5 years. Eligible patients had advanced/metastatic NSCLC and had previously received platinum-based doublet chemotherapy. Patients with EGFR/ALK alterations who had progressed on at least one approved tyrosine kinase inhibitor and had a PD-L1 tumor proportion score (TPS) ≥50% were also eligible. Patients were assigned to 4 cohorts based on their PD-L1 TPS and received camrelizumab intravenously at a dose of 200 mg every 2 weeks. The primary endpoint was ORR. A total of 146 patients were enrolled between May 24, 2017 and Aug 1, 2018. As of the data cutoff on Aug 31, 2023, the median follow-up was 62.3 months (95% CI 57.7–65.3), and 111 (76.0%) death events occurred. The median OS was 14.8 months (95% CI 10.2–18.7), and the 5-year OS rate was 19.3% (95% CI 13.0–26.7). Patients with positive PD-L1 expression (TPS ≥1%) continued to derive a greater benefit in longer-term OS from camrelizumab (Table). No new safety signals with camrelizumab were identified.Table: 74POS resultsPD-L1 TPSNOS, months, median (95% CI)3-year OS rate, % (95% CI)4-year OS rate, % (95% CI)5-year OS rate, % (95% CI)Total14614.8 (10.2–18.7)25.3% (18.2–33.0)21.9% (15.2–29.4)19.3% (13.0–26.7)<1%749.2 (6.5–15.4)17.8% (9.7–27.7)11.3% (5.1–20.3)7.8% (2.8–16.2)≥1–<25%3122.5 (11.6–NR)37.4% (19.5–55.4)37.4% (19.5–55.4)37.4% (19.5–55.4)≥25–<50%1134.2 (2.9–51.9)30.7% (7.3–58.6)30.7% (7.3–58.6)20.5% (3.2–48.2)≥50%3019.3 (9.0–33.3)31.3% (15.5–48.5)31.3% (15.5–48.5)31.3% (15.5–48.5)≥50% & EGFR-2523.3 (9.0–63.3)33.4% (15.6–52.3)33.4% (15.6–52.3)33.4% (15.6–52.3)≥1%7222.5 (13.2–32.3)33.0% (21.8–44.7)33.0% (21.8–44.7)31.3% (20.3–42.9) Open table in a new tab The updated analysis demonstrates the long-term efficacy of camrelizumab as a second-line treatment in pre-treated advanced/metastatic NSCLC, especially in patients with positive PD-L1 expression. Our findings further consolidate camrelizumab as an established and efficacious therapeutic approach for this patient population.