On June 30, the official website of the National Medical Products Administration (NMPA) announced that Anlotinib, a Class 1 new drug developed by Chia Tai Tianqing, has received approval for a new indication in China: combination therapy with chemotherapy for the first-line treatment of patients with unresectable locally advanced or metastatic soft tissue sarcoma (STS) who have not previously received systemic therapy. This marks the ninth indication approved for Anlotinib in China and signifies the official approval of the world’s first chemotherapy combination therapy for the first-line treatment of advanced or metastatic STS.
Anlotinib (AL3818, Anlotinib Hydrochloride) is a novel small-molecule multi-target tyrosine kinase inhibitor (TKI) that effectively inhibits kinases such as VEGFR, PDGFR, FGFR, and c-Kit, exerting anti-tumor angiogenesis and tumor growth-inhibiting effects.
Soft tissue sarcoma (STS) is a type of malignant tumor originating from non-epithelial extraskeletal tissues, with an annual incidence rate of approximately 2.91 per 100,000 population in China, showing an upward trend year by year [1-3]. STS encompasses 19 histological types and over 50 distinct pathological subtypes. For decades, anthracycline-based chemotherapy has served as the cornerstone of first-line treatment for STS.
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the company presented breakthrough results from the Phase III clinical study of Anlotinib Hydrochloride Capsules in combination with chemotherapy for the first-line treatment of unresectable advanced or metastatic STS.
Methods:Eligible pts had previously untreated, pathologically confirmed, unresectable locally advanced or metastatic STS. Pts were randomized in a 1:1 ratio to receive either ALTN (12mg) orally once daily (2-week on/1-week off) plus EH (90 mg/m2) intravenously once every 3 weeks up to 6 cycles, followed by maintenance ALTN (12mg) orally once daily (2-week on/1-week off) or PBO (0mg) orally once daily (2-week on/1-week off) plus EH(90 mg/m2) intravenously once every 3 weeks up to 6 cycles, followed by maintenance PBO (0mg) orally once daily (2-week on/1-week off). The primary endpoint was PFS assessed by the blinded independent review committee according to RECIST 1.1. Secondary endpoint included OS, Objective Response Rate (ORR), Disease control rate (DCR) and safety.
Results:A total of 272 pts were randomized: 135 to ALTN + EH arm, 137 to PBO + EH arm. As of February 15, 2024, after a median follow-up of 7.16 mo, ALTN + EH arm significantly improved PFS (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; median 8.57 vs 3.02 mo), and ORR (17.8% vs 2.90%; P < 0.001) , DCR (79.3% vs 54.7%; P < 0.001) versus PBO + EH arm. The median OS was not reached in either arm (HR = 0.78 [95% CI: 0.49-1.25]). The benefit of ALTN + EH arm was observed across most subgroups tested, including leiomyosarcoma, synovial sarcoma and other pathological types. The incidence of Grade ≥3 adverse events (AEs) (69.6% vs 59.1%), AEs leading to discontinuation of treatment (3.7% vs 4.4%), fatal AEs (3.7% vs 3.6%) were similar between two arms.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Jul-01-2025