Sino Biopharmaceutical Limited announced that Benmelstobart in combination with Anlotinib has received approval for marketing from the National Medical Products Administration (NMPA) of China for the treatment of advanced or unresectable alveolar soft part sarcoma (ASPS). Benmelstobart and Anlotinib are category 1 innovative drugs independently developed by the Group?s subsidiary, Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ).
This marks the fourth approved indication for this combination therapy, following prior approvals in China for the treatment of first-line small cell lung cancer, second-line or later endometrial cancer, and first-line renal cell carcinoma. Benmelstobart is an innovative humanised anti-PD-L1 monoclonal antibody with a novel sequence; this marks its fifth approved indication. Anlotinib is a novel, orally administered, multi-targeted small-molecule tyrosine kinase inhibitor (TKI); this marks its eleventh approved indication.
This approval is supported by robust data from the TQB2450-Ib-02 clinical study. The results showed that the primary endpoint, objective response rate (ORR), reached 72.41%, with 10.34% of subjects achieving complete response (CR) as their best response. Prior chemotherapy history had no significant impact on ORR, and no new safety signals were observed.
With a median follow-up of 24.9 months, the median progression-free survival (PFS) had not yet been reached. ASPS is a rare, highly metastatic soft tissue malignancy with a poor prognosis, commonly occurring in adolescents, accounting for approximately 0.5%-1.0% of soft tissue sarcomas. However, ASPS is not sensitive to radiotherapy or chemotherapy, and radiotherapy is often ineffective in controlling tumour growth and metastasis.
There are limited treatment options, with a recurrence rate as high as 70% and a 5-year overall survival rate of only 20%-46%. Anlotinib has received a Grade I recommendation (Class 2A evidence) in the Chinese Society of Clinical Oncology (CSCO): Guidelines for the Diagnosis and Treatment of Bone and Soft Tissue Tumours (2024 Edition) for the first-line treatment of advanced ASPS. On this basis, the successful approval of Benmelstobart in combination with Anlotinib will provide a new treatment option for these patients.
