The European Society for Medical Oncology (ESMO) Congress 2025 was held from October 17-21 (local time) in Berlin, Germany, bringing together cutting-edge concepts and the latest breakthroughs in international oncology research and treatments. 

Affinity Biopharma’s first Phase III pivotal trial of Legubicin, an independently developed, Tumor MicroEnvironment–Activated (TMEA) small molecule/ albumin-drug conjugate, has been selected as the Late-Breaking Abstract (LBA) at ESMO. The data would be presented for the first time during the Proffered Paper Session: Sarcoma on October 19 (local time). This clinical trial is a first-line, randomized, double-blind, head-to-head pivotal study of Legubicin versus doxorubicin in soft tissue sarcoma indication. Meanwhile, Legubicin continues to be explored in clinical studies across multiple cancer types.

Details of the Oral Presentation:

·        Abstract Number: LBA97

·        Title: Legubicin versus doxorubicin (DOX) in patients (pts) with advanced soft tissue sarcoma (STS): results of a randomized Phase II/III study

·        Speaker: Zan Shen (Shanghai Sixth People’s Hospital)

·        Session: Proffered Paper Session: Sarcoma

·        Presentation Time (local): October 19, 2025, 16:30–16:40 (Beijing Time: 22:30–22:40)

·        Location: Dortmund Auditorium – Hall 7.1a

Professor Zan Shen, Principal Investigator of QHL-Legubicin-102 and Director of the Department of Oncology at Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, delivered an oral presentation at the conference, sharing this important research outcome with the global community. This marks the top-tier clinical evidence in the field of advanced soft tissue sarcoma in China has been recognized by a leading international academic conference.  

The trial enrolled a total of 306 patients with advanced STS. Results demonstrated that the primary endpoint, progression-free survival (PFS) of QHL-Legubicin-102 was significantly superior to that of doxorubicin. The median PFS (mPFS) assessed by independent review committee (IRC) reached 10.4 months vs. 4.9 months favoring legubicin over doxorubicin, with  HR = 0.50 [95% CI: 0.35–0.70], one-sided P < 0.0001. Significant overall survival (OS) benefit was also observed with legubicin, with P25 OS reaching 23.6 months vs. 13.8 months, HR = 0.49 [95% CI: 0.30–0.79], reflecting a >70% improvement. Legubicin further demonstrated higher ORR (objective response rate) and DCR (disease control rate) compared with doxorubicin, consistent with other efficacy results.

Regarding safety, the rate of grade ≥3 cardiotoxicity, the major doxorubicin-related dose-limiting toxicity, was reduced over 20-fold (legubicin: 1.9% vs. doxorubicin: 39.7%). Other common grade ≥3 treatment-related adverse events (TRAEs) were also substantially lowered with legubicin, including hematologic (30.6% vs. 92.5%), gastrointestinal (0% vs. 3.4%), and treatment-related alopecia (13.8% vs. 74.0%).     

This study demonstrated statistically significant and clinically meaningful benefits, supporting legubicin as a promising and safe STS therapy with long-term maintenance treatment potential. It indicates the possibility of replacing doxorubicin across multiple STS subtypes, and provides clinical proof for legumain-activated ALDC. It may reshape the chemotherapy and combination therapy paradigm by overcoming the dose limitations of anthracyclines, thereby enabling broader clinical application and benefiting more patients.