Abstract CT232: A phase II study of toripalimab plus anlotinib as maintenance therapy in extensive-stage small cell lung cancer

Abstract

Abstract A phase II study of toripalimab plus anlotinib as maintenance therapy in extensive-stage small cell lung cancer Background: Maintenance therapy is a promising therapeutic approach for extensive-stage small cell lung cancer (ES-SCLC), especially in light of the IMpower 133 trial (Horn NEJM 2018). The results of the E3501, SALUTE, and CALGB 30306 trials showed that in first-line treatment of ES-SCLC, bevacizumab combined with chemotherapy improved only progression-free survival (PFS) but not overall survival (OS). However, in the ALTER 1202 study, anlotinib used as a third- or further-line treatment in patients with ES-SCLC improved PFS and OS (Cheng WCLC 2018). Toripalimab is a novel PD-1 inhibitor that, when combined with anlotinib as maintenance therapy for ES-SCLC, may improve disease control.Methods: This is a phase 2, single-arm study of toripalimab plus anlotinib, a vascular endothelial growth factor receptor inhibitor, as maintenance therapy in adult patients with ES-SCLC following their completion of platinum-based first-line chemotherapy. Eligible patients must have measurable (RECIST v1.1) ES-SCLC, an ECOG performance status of 0 or 1, and are required to have shown complete response, partial response, or stable disease as per RECIST 1.1 following 4–6 cycles of platinum-based chemotherapy. Twenty participants will be enrolled to receive toripalimab (240 mg, IV, Q3W) + anlotinib (12 mg, oral, Q3W). Patients will be treated until the disease progresses, unacceptable toxicity occurs, or for up to 2 years. Prophylactic cranial irradiation will be permitted at the investigator's discretion. The primary endpoints are PFS and OS. Secondary endpoints include safety, objective response rate, disease control rate, and time to response. Exploratory endpoints include Tumor Mutational Burden (TMB) and PD-L1 protein expression, immune gene transcript expression (PD-1, PD-L1, CTLA-4, and others) ,and correlation of these endpoints with clinical responses and drug resistance. This study is currently open and accruing patients. Clinical trial information: NCT04363255. Research Sponsor: Shanghai Junshi Biosciences Co. Citation Format: Dongqing Lv, Guixian Wu, Xiaomai Lin, Ling Lin, Weijia Pan. A phase II study of toripalimab plus anlotinib as maintenance therapy in extensive-stage small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT232.