Maintenance treatment with toripalimab and anlotinib after anthracycline-based chemotherapy in patients with advanced soft tissue sarcoma (TORAN): A single-arm, phase 2 trial.

• DOI: 10.1200/jco.2024.42.16_suppl.11572
• Publication Date: 2024-08-05T19:59:07Z
• Authors: Yaotiao Deng; Jie Liu; Mei Li; Yu Jiang
• Keywords: 03 medical and health sciences; 0302 clinical medicine

11572 Background: In patients with advanced soft tissue sarcoma (STS) who have achieved disease control after anthracycline-based chemotherapy, maintenance therapy is being explored. This study evaluated the efficacy and safety of toripalimab (a monoclonal antibody against programmed cell death-1 receptor) combined anlotinib multitargeted tyrosine kinase inhibitor) as a treatment. Methods: Patients STS at least four cycles first-line chemotherapy were enrolled in this single-arm, phase 2 trial. Fifty are planned to receive treatment anlotinib. The primary endpoint was progression-free survival rate 24 weeks (PFR 24w ) during therapy. Secondary endpoints median (PFS), overall (OS), objective response (ORR), (DCR) safety. Results: By cut-off date Jan 25, 2024, 22 enrolled, including leiomyosarcoma (n =5), synovial =3), epithelioid dedifferentiated liposarcoma =2) other different subtypes sarcomas =9). follow-up time 11 months. Response has been 18 patients. ORR DCR 22.2% 100%. PFR 67%, PFS 11.8 months, OS not reached. grade 3 or higher adverse events hypertension =4), hemorrhage =1), adrenal insufficiency =1) hypertriglyceridemia =1). Conclusions: Maintenance promising option for chemotherapy. Clinical trial information: ChiCTR2100054901.