Chicago, Illinois – The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting is currently underway at the McCormick Place Convention Center in Chicago. As part of the five-day global conference, Wuhan Hiteck Biopharmaceutical Co., Ltd. (Hiteck) is set to showcase preliminary findings from the first investigator-initiated trial of its lead asset, Aponermin for Injection (brand name: SunHiTrail®), during the upcoming poster session.
The
study, entitled "A Multicenter, Single-arm Exploratory Clinical Study on
the Efficacy and Safety of Aponermin for Injection in the Treatment of Advanced
Chondrosarcoma" (ChiCTR2500104488), is among the first to evaluate this novel
agent in patients with advanced chondrosarcoma.
Session
Information Temporary
Abstract Submission ID: 549736 Abstract
Number for Publication: 11532 Abstract
Title: Efficacy and safety of DR4/DR5 agonist Aponermin
monotherapy in advanced chondrosarcoma:Preliminary report from a prospective,
multicenter study. First
Author: Mengxiong Sun, Department of
Orthopaedic Oncology, Shanghai General Hospital, Shanghai Jiao Tong University
School of Medicine, China Presenter:
Zhuqing
Liu, Department of Orthopaedic Oncology, Shanghai General Hospital, Shanghai
Jiao Tong University School of Medicine, China Session
Type/Title: Poster Session - Sarcoma Poster
Board: 322 Date
and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Aponermin
for Injection is a circularly permuted endogenous human tumor necrosis
factor-related apoptosis-inducing ligand (TRAIL). It activates the exogenous
apoptosis pathway by binding to death receptor 4 (DR4) and/or death receptor 5
(DR5) on tumor cell membranes, triggering a cascade reaction of intracellular
cysteine-aspartic proteases (Caspases) and inducing p53-independent apoptosis.
ASCO’s
Annual Meeting is recognized globally as the largest and most influential
oncology conference. The inclusion of Aponermin-related data in this year’s
program reflects growing international recognition of the therapeutic potential
of death receptor agonists in chondrosarcoma treatment. Hiteck plans to
accelerate the development of related pivotal clinical studies, aiming to bring
safe, effective, and innovative treatment options to patients with bone tumors
as soon as possible.
Wuhan
Hiteck Biopharmaceutical Co., Ltd. is a publicly listed biopharmaceutical
company (Shenzhen Stock Exchange: 300683) dedicated to the discovery and
development of innovative biologics and small-molecule therapeutics. The
company focuses on the research, development, manufacturing, and
commercialization of drugs for neurological disorders and oncology. Guided by
its mission of "Innovating for life," Hiteck is dedicated to
advancing innovative therapies that address unmet medical needs and improve
patient outcomes. Looking ahead, Hiteck will continue to expand its
capabilities across biologics, small-molecule therapeutics, and in vitro
diagnostics, driven by sustained innovation and a patient-centered approach,
with the goal of building a leading innovative pharmaceutical group in China.
The
full abstract is presented below: Efficacy
and safety of DR4/DR5 agonist aponermin monotherapy in advanced chondrosarcoma:Preliminary
report from a prospective, multicenter study Mengxiong
Sun, Chongren Wang, YaFei Jiang, Zhuqing Liu, Haoran Mu, Yu Lv, Wei Sun，Yingqi
Hua，Department
of Orthopaedic Oncology, Shanghai General Hospital, Shanghai Jiao Tong
University School of Medicine, China Lu
Xie, Musculoskeletal Tumor Center, Peking University People’s Hospital,
Beijing, China Jie
Xu, Peking University Third Hospital, Beijing, China Peng
Zhang, Department of Bone and Soft Tissue, the Affiliated Cancer Hospital of
Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China Binghao
Li，Department
of Orthopaedics, The Second Affiliated Hospital of Zhejiang University School
of Medicine, Hangzhou, China Fei
Li，Department
of Orthopaedics, Second Hospital of Shanxi Medical University, Taiyuan, China
Background: Reported
median progression-free survival (mPFS) of Chondrosarcoma is less than 4 months
for patients receiving first-line systemic therapy. Aponermin, a recombinant
circularly permuted human Tumor Necrosis Factor-Related Apoptosis-Inducing
Ligand (TRAIL), induces tumor cell apoptosis by activating the extrinsic
apoptotic pathway. This study aimed to evaluate the efficacy of Aponermin in
patients with advanced chondrosarcoma.
Methods: This
prospective, multicenter, single-arm study (Registration No:ChiCTR2500104488)
was approved by an independent ethics committee. The planned enrollment was 32
patients aged 18-75 years with histologically confirmed advanced
chondrosarcoma, documented evidence of disease progression within 6 months
prior to enrollment, ECOG performance status ≤2, and measurable disease per
RECIST 1.1. Patients received intravenous Aponermin 10 mg/kg (days 1-5, every
14 days as one cycle) until disease progression, unacceptable toxicity, or
investigator's decision to discontinue. The primary endpoint was objective
response rate (ORR). Secondary endpoints included 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. Median age was 51
years (range:26-70), with a median of 2 prior surgeries (range:1-6). Eight
patients had received prior drug 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); and one case each (4.8%) of myxoid,
dedifferentiated, clear cell, and unknown subtype. Twenty patients were
evaluable for efficacy. Median treatment duration was 3.6 months (range:0.5-14.0),
with 4 patients still on treatment. Although no objective responses were
observed，80.0%
(16/20) of DCR was achieved. Median PFS was 4.2 months (95% CI:2.9-5.5), and
the 4-month PFS rate was 57.9%. Median OS was not reached. Notably, Among
patients achieving DCR, 50% maintained clinical benefit for over 4 months,
including one patient with conventional grade 3 chondrosarcoma with SD lasting
7.4 months, two patients with conventional grade 2 with SD exceeding 10.0
months, and one patient with clear cell subtype with SD lasting 14 months.
Aponermin demonstrated a favorable safety profile. Treatment-related adverse
events occurred in approximately 9.5% (2/21) of patients, including one case
(4.8%) of grade 1 allergic reaction and one case (4.8%) of hand-foot syndrome,
both alleviated with symptomatic treatment.
Conclusions: Aponermin
monotherapy demonstrated promising disease control and a favorable safety and
tolerability profile in advanced chondrosarcoma. Given the limited sample size
and ongoing enrollment, final efficacy and safety assessments await study
completion.
