Abstract 1169TiP
Background
Immunotherapy alone or combined with chemotherapy as neoadjuvant therapy has shown encouraging results. Penpulimab, a human IgG1 monoclonal antibody directed against human programmed cell death-1 (PD-1), was engineered to eliminate Fc-mediated effector function that compromises anti-tumor immune cell function, and to optimize receptor occupancy by improving duration of drug binding. As a promising multi-target tyrosine kinase inhibitor, Anlotinib significantly improved overall survival in advanced NSCLC patients in the phase III trial ALTER0303. Antiangiogenesis therapy combined with PD-1/PD-L1 inhibitors has shown excellent efficacy in advanced non-small cell lung cancer (NSCLC) patients. This is the trial evaluating Penpulimab combined with Anlotinib or chemotherapy or both of them as neoadjuvant/adjuvant therapy for patients with resectable locally advanced NSCLC.
Trial design
This is a multicenter, randomized, open-label, phase II study (NCT04846634). Eligible patients were 18-70 years old with measurable, pathologically confirmed stage IIB-IIIB (N2) NSCLC patients with negative driver gene mutation. Other key inclusion criteria included ECOG PS of 0-1, adequate organ function and sufficient lung function for the intended lobectomy or pneumonectomy. Patients were randomized to receive either Penpulimab (200mg, iv, Q3W) plus platinum based chemotherapy or Penpulimab (200mg, iv, Q3W) plus Anlotinib (12mg, po, day 1-14, Q3W) or Penpulimab (200mg, iv, Q3W) plus platinum based chemotherapy and Anlotinib (12mg, po, day 1-14, Q3W) in a 1:1:1 ratio. The primary outcome was major pathological response (MPR) rate, the secondary outcomes were objective response rate (ORR), pathologic complete response (pCR), event-free survival (EFS), 1 year EFS rate, overall survival (OS) and safety.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.