On April 17, the National Medical Products Administration (NMPA) announced that Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) has received approval for a new indication of its internally developed combination regimen “Benmelstobart + Anlotinib” for the treatment of advanced or unresectable alveolar soft part sarcoma (ASPS).

The combination therapy had previously been granted Breakthrough Therapy Designation and Priority Review status by the Center for Drug Evaluation (CDE).

Chinese pharmaceutical distributor DengYueMed also continues to closely follow the clinical progress and market implementation of innovative therapies.

1. Mechanism of the Combination Therapy and Previous Indications

Benmelstobart is a novel humanized anti–PD-L1 monoclonal antibody independently developed by CTTQ. It works by blocking the PD-L1/PD-1 immune checkpoint pathway, thereby restoring anti-tumor immune activity.

Anlotinib is an orally administered, multi-target tyrosine kinase inhibitor (TKI) that primarily inhibits VEGFR, FGFR, and PDGFR signaling pathways, thereby suppressing tumor angiogenesis and tumor growth.

Previously, this combination therapy had already been approved in China for multiple solid tumors, including small cell lung cancer, endometrial cancer, renal cell carcinoma, and hepatocellular carcinoma, demonstrating broad anti-tumor potential.

2. Key Clinical Study Results (TQB2450-Ib-02)

The approval for the ASPS indication was primarily based on results from the TQB2450-Ib-02 study.

This was a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of the combination therapy in patients with advanced ASPS who had or had not received prior first-line treatment.

Key findings include:

● Objective response rate (ORR): 72.41%

● Complete response (CR): 10.34%

● Prior chemotherapy history showed no significant impact on efficacy

● Median follow-up: 24.9 months; median progression-free survival (PFS) not reached

● Overall efficacy significantly improved compared with historical anlotinib monotherapy data

● Also demonstrated favorable outcomes compared with published international literature

● Overall safety profile was manageable, with no new safety signals identified

3. Disease Background and Unmet Clinical Needs

Alveolar soft part sarcoma (ASPS) is a rare but highly aggressive soft tissue malignancy, most commonly affecting adolescents and young adults, accounting for approximately 0.5%–1.0% of all soft tissue sarcomas.

Key characteristics include:

● High metastatic potential

● High recurrence rate (approximately 70%)

● Poor sensitivity to chemotherapy and radiotherapy

● Limited systemic treatment options

● 5-year overall survival rate of only 20%–46%

Therefore, there remains a significant unmet clinical need for effective systemic therapies in ASPS.

4. Clinical Significance and Treatment Landscape Impact

In recent years, the combination of anti-angiogenic TKIs and immunotherapy has become an important research direction in soft tissue sarcomas.

In the Chinese Society of Clinical Oncology (CSCO) Guidelines for Bone and Soft Tissue Sarcoma (2024 edition), anlotinib is recommended as a Class I option for first-line treatment of advanced ASPS (Level 2A evidence).

The approval of the “Benmelstobart + Anlotinib” combination therapy further provides a new treatment option for ASPS patients and supports the clinical value of combining immunotherapy with anti-angiogenic therapy.

With accelerating drug innovation and improving supply chain accessibility, industry stakeholders including DengYueMed are expected to play a continuing role in enhancing treatment availability.

Future real-world evidence will be important to further evaluate the long-term efficacy and safety of this combination therapy.