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Cheng Huang
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P78 - Immunotherapy (Phase II/III Trials) - Immune Checkpoint Inhibitor Single Agent (ID 255)
- Event: WCLC 2020
- Type: Posters
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P78.03 - Camrelizumab Umbrella Trial Based on PD-L1 Expression: OS and PFS2 in Pre-Treated Advanced NSCLC (ID 1453)
00:00 - 00:00 | Presenting Author(s): Cheng Huang
- Abstract
Introduction
In a phase II umbrella study (NCT03085069), camrelizumab (a potent anti–PD-1 monoclonal antibody) demonstrated promising efficacy and manageable safety profile as second-line treatment in advanced/metastatic NSCLC. Patients with higher PD-L1 expression derived greater benefit from camrelizumab. Here we present an updated OS, PFS, and PFS2 based on longer follow-up.
Methods
Patients who had progressed during or following platinum-based doublet chemotherapy were enrolled and assigned to 4 cohorts according to PD-L1 tumor proportion score (TPS) to receive camrelizumab at 200 mg IV Q2W. Patients with EGFR or ALK alterations who had progressed on at least one approved tyrosine kinase inhibitor and with PD-L1 TPS ≥50% were eligible. PFS2 was defined as time from first dose of camrelizumab to objective tumor progression on next-line treatment or death from any cause, whichever occurred first.
Results
From May 24, 2017 to Aug 1, 2018, 146 patients were enrolled. As of data cutoff on Jan 31, 2020, the median follow-up was 22.9 months (95% CI 21.7–24.2). Median OS and PFS was 14.8 months (95% CI 10.3–18.8) and 3.2 months (95% CI 2.0–3.4), respectively. Third-line therapy and beyond was received by 65 (44.5%) patients. PFS2 was 10.0 months (95% CI 8.2–12.4). Subgroup analysis showed that patients with positive PD-L1 TPS commonly had longer PFS and PFS2 (Table 1). No new safety signal with camrelizumab was identified.
Table 1 Survival of camrelizumab in PD-L1 TPS subgroups
Population No. of patients OS (months), median (95% CI) PFS (months), median (95% CI) PFS2 (months), median (95% CI) PD-L1 TPS <1% 74 9.2 (6.5–15.4) 2.1 (1.9–3.2) 7.5 (5.7–8.9) PD-L1 TPS ≥1% 72 23.3 (13.2–NR) 3.8 (2.0–7.2) 16.6 (10.2–19.8) PD-L1 TPS 1–49% 42 NR (14.8–NR) 3.4 (1.8–6.0) 16.9 (10.2–20.4) PD-L1 TPS ≥50% (without EGFR alterations) 25 23.3 (9.0–NR) 7.6 (2.0–16.8) 18.7 (9.0–26.8) PD-L1 TPS ≥50% (with EGFR alterations) 5 10.3 (1.2–NR) 1.7 (1.2–NR) 9.8 (1.2–16.6) ITT 146 14.8 (10.3–18.8) 3.2 (2.0–3.4) 10.0 (8.2–12.4) NR, not reached.
Conclusion
The updated results demonstrated improved survival compared with historical data of the second-line chemotherapy. Patients with positive PD-L1 expression derived greater benefit from camrelizumab. These data supported the long-term outcome of camrelizumab as the second-line therapy in advanced/metastatic NSCLC.
