Abstract 1176P
Background
Previous studies showed neoadjuvant therapy with a programmed cell death protein 1 (PD-1) inhibitor could benefit patients (pts) with resectable non-small-cell lung cancer (NSCLC). On this basis, we initiated a phase II clinical trial to report the safety and effectiveness of neoadjuvant Toripalimab plus chemotherapy in local advanced NSCLC.
Methods
Study eligibility involved stage ⅡA-ⅢC, wildtype EGFR/ALK NSCLC pts with ECOG PS 0-1 status. Pts received 2-4 courses of Toripalimab (240mg, q3w) plus Carboplatin-based chemotherapy. After the second treatment cycle, all pts were reassessed by the multidisciplinary team. Candidates for complete resection underwent surgery otherwise they received the remaining treatment cycles. Pts showing disease progression after all neoadjuvant therapy were excluded. Primary endpoints were major pathological response (MPR), pathological complete response (pCR), and safety. Secondary endpoints were overall survival and disease-free survival.
Results
A total of 48 eligible pts were enrolled since June 2020. Their median age was 66 (34-77); 41 were male and 34 had a smoking history. Disease distribution in stage ⅡB, ⅢA, ⅢB and ⅢC consisted of 4, 24, 15 and 5 pts, respectively. Histopathological diagnosis from pre-treatment biopsy identified 31 pts with squamous cell carcinoma, 9 pts with adenocarcinoma and 8 pts with NSCLC. Among the 40 pts receiving radiological reassessment at the last neoadjuvant treatment cycle, 2 pts had progressive disease, 8 pts had stable disease, 23 pts had partial response (57.5%) and 7 pts had complete response (17.5%). R0 resection was realised for all 22 pts (100%) receiving surgery without any serious surgical complications. Of these, 9 pts achieved MPR (40.9%) and 4 pCR (18.2%). No treatment-related death occurred but treatment-related adverse events (TRAEs) were recorded in 42 pts (87.5%). Three pts (6.2%) exhibited serious TRAEs involving myelosuppression, pulmonary infection, and drug-induced liver injury, respectively.
Conclusions
Interim trial results suggest that neoadjuvant toripalimab plus chemotherapy is safe and effective for patients with stage Ⅱ-Ⅲ and EGFR/ALK wild type NSCLC.
Clinical trial identification
ChiCTR1900024014.
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Pulmonary Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.