Abstract 942P
Background
Several studies have shown that the combination of programmed cell death 1 (PD-1) inhibitor and chemotherapy is efficacious for resectable non-small-cell lung cancer (NSCLC). However, there are few studies on neoadjuvant immunotherapy for early stage lung squamous cell carcinoma (LUSC). This phase II study aimed to evaluate the efficacy and safety of adding camrelizumab to standard neoadjuvant chemotherapy in early LUSC.
Methods
In this single-arm phase II trial (ChiCTR2100044645), eligible patients were aged 18-70 years with previously untreated, histologically confirmed stage IIB-IIIB LUSC. Patients received camrelizumab (200 mg on day 1), albumin paclitaxel (90 mg/m2 on days 1 and 8) and a platinum agent (carboplatin area under the curve of 5 or cisplatin 75 mg/m2 on day 1) intravenously every 3-week cycle for two to four cycles, followed by surgery after 3-4 weeks. After surgery, patients received adjuvant treatment with camrelizumab monotherapy for 1 year. The primary endpoint was major pathological response (MPR).
Results
From March 2021 to March 2022, 26 patients were enrolled. As of April 8, 2022, all 26 patients received neoadjuvant therapy and 22 (22/26, 84.6%) had completed prescribed treatment, of whom 17 (17/22, 77.3%) underwent surgical resection. Among all the patients regardless of resection, the MPR rate was 38.5% (10/26, 95% CI 20.2%-59.4%), and the pathological complete response rate was 19.2% (5/26, 95% CI 7.6%-39.4%). Treatment-related adverse events (TRAEs) occurred in 10 patients (10/26, 38.4%) and two (2/26, 7.6%) experienced grade 3 or 4 TRAEs. The most common TRAEs were rash (15.4%), myelosuppression (11.5%), hemoptysis (7.7%), immune dermatitis (3.8%) and diarrhea (3.8%). Of the 17 patients who had surgery, eight (47.1%) patients reported surgery-related complications, of whom six (35.3%) had intraoperative blood loss > 400 ml and five (29.4%) had postoperative indwelling catheter duration ≥ 7 days. Neither unexpected safety signals nor treatment-related death occurred.
Conclusions
The addition of camrelizumab to neoadjuvant chemotherapy showed promising antitumor activity and manageable toxicity for resectable LUSC.
Clinical trial identification
ChiCTR2100044645, March 25, 2021.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Disclosure
All authors have declared no conflicts of interest.