Abstract 1296P
Background
Our phase 2 trial was the first to report the efficacy and safety of neoadjuvant chemo-free regimen with camrelizumab and apatinib in patients with resectable non-small-cell lung cancer (NSCLC), showing promising pathologic responses and manageable toxicity. Here, we aimed to report 1-year event-free survival (EFS) and updated safety data from the above trial.
Methods
Treatment-naïve patients with histologically confirmed resectable stage IIA-IIIB NSCLC (stage IIIB, T3N2 only) and ECOG performance status of 0 or 1 received three cycles of camrelizumab (200 mg, i.v., q2w) and apatinib (250 mg, orally, qd, for 5 days followed by 2 days off), followed by surgery after 3-4 weeks. This analysis including EFS (a prespecified secondary endpoint) and updated safety was performed after an extended follow-up from the preliminary analysis.
Results
Between November 9, 2020 and February 16, 2022, 78 patients were enrolled and treated. With a median follow-up of 19.4 months (95% CI 18.0-20.5), the median EFS was not reached (95% CI 23.2-not reached). The 6- and 12-month EFS rates were 89.4% (95% CI 79.8-94.5) and 82.3% (95% CI 71.4-89.3), respectively. The EFS rates at 6 months and 12 months in the subgroups are presented in the Table. Seventy-one (91.0%) of the 78 patients experienced at least one treatment-related adverse event (TRAE) of any grade, of which grade 3 or above TRAEs were observed in six (7.7%) patients. No new safety signal was observed. Table: 1296P
| Subgroup | Patients (n = 78), n (%) | 6-month EFS rate, % (95% CI) | 12-month EFS rate, % (95% CI) |
| Overall | 78 (100) | 89.4 (79.8-94.5) | 82.3 (71.4-89.3) |
| Disease stage | |||
| II | 38 (48.7) | 94.5 (79.8-98.6) | 86.2 (69.9-94.0) |
| III | 40 (51.3) | 84.5 (68.7-92.8) | 78.7 (61.8-88.8) |
| PD-L1 expression | |||
| <1% | 35 (55.6) | 85.3 (68.2-93.6) | 76.2 (57.9-87.3) |
| ≥1% | 28 (44.4) | 92.9 (74.3-98.2) | 85.4 (65.7-94.3) |
| Histologic type | |||
| Squamous cell carcinoma | 59 (75.6) | 91.2 (80.2-96.2) | 84.1 (71.6-91.4) |
| Adenocarcinoma | 19 (24.4) | 83.9 (57.9-94.5) | 76.9 (49.0-90.8) |
Conclusions
The extended follow-up data shows continued benefits and a manageable safety profile with neoadjuvant camrelizumab and apatinib in patients with resectable non-small-cell lung cancer.
Clinical trial identification
ChiCTR2000033588.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
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