공지 • Oct 21
Remegen Co., Ltd Announces ESMO Congress 2025 Presidential Symposium Oral Presentation | Disitamab Vedotin Achieves Major Breakthrough as First-Line Treatment for Urothelial Carcinoma
RemeGen Co., Ltd. announced that At the 2025 European Society for Medical Oncology (ESMO) Congress, a Phase III clinical study on disitamab vedotin plus toripalimab versus chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (RC48-C016) sponsored by RemeGen Co., Ltd. was presented at the Presidential Symposium by Professor Jun Guo from Beijing Cancer Hospital. It's the first time a research led by Chinese scholars in the field of urological oncology has ever been selected in this honorable session. The full manuscript was simultaneously published online in The New England Journal of Medicine (NEJM). This marks the first time that the results of a Chinese evidence-based medical research in the field of urothelial carcinoma have been recognized by both an authoritative international academic conference and a top-tier journal. The results showed that the RC48-C016 study met the dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS). The Blinded Independent Central Review (BICR)-assessed median PFS reached 13.1 months, and the median OS reached 31.5 months, demonstrating both statistical and clinical significance. The RC48-C016 trial is by now the only randomized controlled study from China providing high-level evidence for HER2-ADC as a first-line treatment of HER2-expressing (IHC 1+/2+/3+) locally advanced/metastatic urothelial carcinoma (la/mUC). The results garnered high attention and sparked lively discussion among global scholars upon release. On the afternoon of October 19 (local time), a pivotal moment arrived at the ESMO Congress: Professor Guo Jun, the principal investigator of the RC48-C016 study, delivered a featured oral presentation at the Presidential Symposium, unveiling the breakthrough results globally for the first time. The RC48-C016 study is a randomized controlled, multi-center, phase III clinical trial. It compares the efficacy and safety of disitamab vedotin combined with toripalimab versus gemcitabine combined with cisplatin or carboplatin in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have not received systemic treatment and have HER2 expression (HER2 IHC 1+/2+/3+). The study was initiated in June 2022, with 76 clinical research centers across the country participating, and a total of 484 patients were enrolled. The dual primary endpoints of the study are PFS and OS, and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), and safety, etc. Results as of March 31, 2025, showed: Regarding PFS, the median PFS in the disitamab vedotin combination group reached 13.1 months, more than doubling the 6.5 months in the chemotherapy group and reducing the risk of disease progression or death by 64% (Hazard Ratio [HR] =0.36, 95% CI: 0.28 - 0.46, P < 0.0001). The OS data were equally exciting. In this interim survival analysis, the median OS in the disitamab vedotin combination group was 31.5 months, compared to 16.9 months in the platinum-based chemotherapy group. The delayed disease progression has been well translated into long-term survival benefit as the overall survival time almost doubled as compared to chemotherapy, with a 46% reduction in the risk of death (HR = 0.54, 95% CI: 0.41 - 0.73, P < 0.0001). Regarding tumor response, the ORR assessed by BICR reached 76.1% in the disitamab vedotin combination group, far exceeding the 50.2% in the chemotherapy group. For disease control, the DCR in the disitamab vedotin combination group reached 91.4%, significantly higher than the 77.6% in the chemotherapy group. In key subgroup analyses, significant improvements in median PFS and median OS were observed in the disitamab vedotin combination group compared to the platinum-based chemotherapy across subgroups, regardless of cisplatin eligibility, HER2 expression status, or primary tumor site. Furthermore, the combination regimen demonstrated a better safety profile. The overall incidence of Grade =3 treatment-related adverse events was only 55.1% in the disitamab vedotin combination group, significantly lower than the 86.9% in the chemotherapy group.