Abstract 74P
Background
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.
Methods
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.
Results
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: 74P
OS results
| PD-L1 TPS | N | OS, months, median (95% CI) | 3-year OS rate, % (95% CI) | 4-year OS rate, % (95% CI) | 5-year OS rate, % (95% CI) |
| Total | 146 | 14.8 (10.2–18.7) | 25.3% (18.2–33.0) | 21.9% (15.2–29.4) | 19.3% (13.0–26.7) |
| <1% | 74 | 9.2 (6.5–15.4) | 17.8% (9.7–27.7) | 11.3% (5.1–20.3) | 7.8% (2.8–16.2) |
| ≥1–<25% | 31 | 22.5 (11.6–NR) | 37.4% (19.5–55.4) | 37.4% (19.5–55.4) | 37.4% (19.5–55.4) |
| ≥25–<50% | 11 | 34.2 (2.9–51.9) | 30.7% (7.3–58.6) | 30.7% (7.3–58.6) | 20.5% (3.2–48.2) |
| ≥50% | 30 | 19.3 (9.0–33.3) | 31.3% (15.5–48.5) | 31.3% (15.5–48.5) | 31.3% (15.5–48.5) |
| ≥50% & EGFR- | 25 | 23.3 (9.0–63.3) | 33.4% (15.6–52.3) | 33.4% (15.6–52.3) | 33.4% (15.6–52.3) |
| ≥1% | 72 | 22.5 (13.2–32.3) | 33.0% (21.8–44.7) | 33.0% (21.8–44.7) | 31.3% (20.3–42.9) |
Conclusions
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.
Clinical trial identification
NCT03085069.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
X. Li, X. Ma, W. Shi: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd. Y. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merck, MSD, Pfizer, Roche, Sanofi, AstraZeneca, Boehringer Ingelheim, BMS, Hengrui, Merck, MSD, Pfizer, Roche, Sanofi, Yunhan, Eli Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Takeda; Non-Financial Interests, Personal, Leadership Role: Chinese Thoracic Oncology Group (CTONG); Non-Financial Interests, Personal, Other, WCLC 2020 Conference Chair: IASLC; Non-Financial Interests, Personal, Leadership Role, Past President: Chinese Society of Clinical Oncology (CSCO). All other authors have declared no conflicts of interest.