KEY TAKEAWAYS
- The phase 2 trial aimed to investigate the long-term efficacy and safety of camrelizumab as a 2L treatment in pre-treated advanced/metastatic NSCLC patients.
- The primary endpoint was to determine ORR.
- Researchers noticed that Camrelizumab shows sustained efficacy in pre-treated NSCLC, especially with positive PD-L1 expression, reinforcing its therapeutic value.
In an open-label, single-arm, multicenter phase II study, camrelizumab demonstrated promising efficacy as a second-line treatment in pre-treated advanced/metastatic Non-Small Cell Lung Cancer (NSCLC), with those exhibiting positive PD-L1 expression deriving greater benefit from camrelizumab (Yang et al., Cancer Immunol Immunother, 2021).
J. Yang and the team aimed to present an updated analysis of the efficacy and safety outcomes from this study, which had an approximate 5-year follow-up period.
They performed an inclusive analysis of eligible patients with advanced/metastatic NSCLC who had previously undergone platinum-based doublet chemotherapy. Additionally, 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 included. Patients were categorized into 4 cohorts based on their PD-L1 TPS and treated with camrelizumab intravenously at a dose of 200 mg every 2 weeks. The primary endpoint assessed was objective response rate (ORR).
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. No new safety signals with camrelizumab were identified.
The study concluded that the updated analysis underscores the sustained long-term efficacy of camrelizumab as a second-line treatment for pre-treated advanced/metastatic NSCLC, particularly in patients with positive PD-L1 expression. These findings reinforce camrelizumab’s position as an established and efficacious therapeutic option for this specific patient population.
The trial was sponsored by the Jiangsu HengRui Medicine Co., Ltd.
Clinical Trial: https://clinicaltrials.gov/study/NCT03085069
J. Yang, C. Huang, Y. Fan, et al. (2024). “Five-year survival outcomes of camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic NSCLC: A phase II study.” Presented at ELCC 2024 (Abstract 74P).
