At the 2026 ASCO Annual Meeting (American Society of Clinical Oncology), preliminary data from the first Investigator-Initiated Trial (IIT) of Aponermin for Injection (Brand Name: Sha-Ai-Te®) was selected for a poster presentation. The study is titled: "Efficacy and safety of DR4/DR5 agonist aponermin monotherapy in advanced chondrosarcoma: A multicenter, single-arm exploratory clinical study" (ChiCTR2500104488).

Aponermin is a circularized allosteric variant of the human tumor necrosis factor-related apoptosis-inducing ligand (TRAIL). As the world's first marketed DR4/DR5 agonist, it activates the extrinsic apoptosis pathway by binding to Death Receptor 4 (DR4) and/or Death Receptor 5 (DR5) on the surface of tumor cells. This triggers a Caspase cascade reaction, inducing P53-independent cell apoptosis.

The ASCO Annual Meeting is recognized as the world's largest and most influential gathering in the field of oncology. The 2026 meeting will be held from May 29 to June 2 in a hybrid format at the McCormick Place Convention Center in Chicago, Illinois. The selection of Aponermin’s results for a poster presentation reflects the international oncology community's recognition of the potential of death receptor agonists in treating chondrosarcoma. Wuhan Hiteck Pharmaceutical Co., Ltd. remains committed to accelerating current research to provide safe, effective, and innovative treatment options for patients with bone tumors, following its success in hematological malignancies.

Abstract Details and Presentation Schedule

• Abstract Title: Efficacy and safety of DR4/DR5 agonist aponermin monotherapy in advanced chondrosarcoma: Preliminary report from a prospective, multicenter study.
• Abstract Number for Publication: 11532
• Poster Board: 322
• Presentation Time: June 1, 2026, 1:30 PM - 4:30 PM (Central Daylight Time, CDT)

2026 ASCO Abstract Content

Authors

Mengxiong Sun, Chongren Wang, Yafei Jiang, Zhuqing Liu, Haoran Mu, Yu Lyu, Wei Sun, Yingqi Hua (Shanghai First People's Hospital); Jie Xu (Peking University Third Hospital); Lu Xie (Peking University People's Hospital); Binghao Li (The Second Affiliated Hospital of Zhejiang University School of Medicine); Peng Zhang (Henan Cancer Hospital); Fei Li (Second Hospital of Shanxi Medical University).

Background

Published data indicate that the median progression-free survival (mPFS) for chondrosarcoma patients receiving first-line systemic therapy is less than 4 months. Aponermin is a recombinant human TRAIL variant that induces apoptosis via the extrinsic pathway. This study aims to evaluate the efficacy of Aponermin in patients with advanced chondrosarcoma.

Methods

This prospective, multicenter, single-arm study (ChiCTR2500104488) was approved by the Independent Ethics Committee of Shanghai First People's Hospital. The study planned to enroll 32 patients (ages 18–75) with histologically confirmed advanced chondrosarcoma, clinical evidence of disease progression within the prior 6 months, an ECOG performance status of ≤2, and measurable lesions per RECIST 1.1. Patients received 10 mg/kg Aponermin intravenously (Days 1–5, every 14 days per cycle) until disease progression, unacceptable toxicity, or investigator discretion. The primary endpoint is the Objective Response Rate (ORR). Secondary endpoints include the 4-month PFS rate, Disease Control Rate (DCR), Overall Survival (OS), and safety.

Results

As of January 23, 2026, 21 patients were enrolled and treated. The median age was 51 (range: 26–70), and the median number of prior surgeries was 2 (range: 1–6). Eight patients had received prior systemic therapy. Histopathological subtypes included:

• Conventional Grade 1: 19% (4/21)
• Conventional Grade 2: 47.6% (10/21)
• Conventional Grade 3: 4.8% (1/21)
• Mesenchymal: 9.5% (2/21)
• Myxoid, Dedifferentiated, Clear Cell, and Unknown: 1 case each (4.8% each).

Efficiency was evaluable in 20 patients. The median duration of treatment was 3.6 months (range: 0.5–14.0), with 4 patients still on treatment. While no objective responses were observed, the DCR reached 80.0% (16/20). The median PFS was 4.2 months (95% CI: 2.9–5.5), and the 4-month PFS rate was 57.9%. Median OS has not yet been reached.

Notably, among patients achieving disease control, 50% maintained clinical benefit for over 4 months. This included one patient with Conventional Grade 3 chondrosarcoma (Stable Disease [SD] for 7.4 months), two patients with Conventional Grade 2 (SD > 10.0 months), and one patient with the Clear Cell subtype (SD for 14 months). Aponermin demonstrated a favorable safety profile; treatment-related adverse events (TRAEs) occurred in 9.5% (2/21) of patients, including one case of Grade 1 allergic reaction and one case of hand-foot syndrome, both resolved with symptomatic treatment.

Conclusion

Aponermin monotherapy shows promising disease control and excellent safety/tolerability in advanced chondrosarcoma. Given the limited sample size and ongoing enrollment, final efficacy and safety results await further evaluation.