Abstract 599P
Background
Perioperative chemotherapy with immunotherapy improves pCR, EFS, and OS in stage II-IIIA NSCLC. Previous studies show anlotinib + sintilimab enhances ORR, PFS, and DOR in advanced NSCLC. This study compares perioperative anlotinib+sintilimab with chemotherapy+ immunotherapy.
Methods
This study included patients with resectable stage II-IIIA NSCLC without driver genes. Patients were randomized to three cycles of anlotinib (12mg orally, 2 weeks on/1 week off) + sintilimab (200mg) q3w or chemotherapy (albumin-bound paclitaxel 240mg/m2) + immunotherapy (nivolumab 360mg, toripalimab 240mg, or tislelizumab 200mg) q3w, followed by surgery within 4-6 weeks. Postoperatively, the anlotinib + sintilimab group continued for one cycle, then single-agent immunotherapy for 13 cycles. The chemotherapy + immunotherapy group received one more combined cycle, then single-agent immunotherapy for 13 cycles. Primary endpoints were pCR rate. Secondary endpoints included MPR rate, 1-year EFS rate, EFS, and safety.
Results
This study is still being enrolled.In the anlotinib+sintilimab group (14 patients), 1 refused surgery, 1 was in the neoadjuvant phase, and 12 had R0 resection. The chemotherapy+immunotherapy group (16 patients) had radical resection. The anlotinib+ sintilimab group had 7 pCR (58.3%) and 5 MPR (41.7%) patients. The chemo+immuno group had 5 pCR (31.3%) and 2 MPR (12.5%) patients. DCR was 100% in both groups; ORR was 85.7% for anlotinib + sintilimab and 81.3% for chemo+immuno. One patient in the anlotinib+sintilimab group had grade 3 hyperlipidemia, and other adverse events were grade 1-2. The chemo+ immuno group had 3 patients with grade 3 hematologic toxicity and 1 with grade 3 liver function damage, all resolving after treatment. EFS has not been reached. The 1-year EFS rate was 100% in the anlotinib+sintilimab group and 96% in the chemo+immuno group.
Conclusions
Perioperative anlotinib+sintilimab significantly improves pCR rates compared to chemotherapy+immunotherapy in resectable stage II-IIIA NSCLC patients and may be an effective and safe treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Chest Hospital, Shanghai Jiao Tong University.
Funding
Development Center for Medical Sdience & Technology National Health Commission of the People's Republic of China.
Disclosure
All authors have declared no conflicts of interest.