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This study was initiated in June, 2022 and aimed at comparing the efficacy and safety between Disitamab Vedotin plus Toripalimab and Gemcitabine plus cisplatin/carboplatin in treating HER2-expressing (HER2 IHC 1+, 2+ or 3+) locally advanced or metastatic urothelial carcinoma. HER2-expressing locally advanced or metastatic urothelial carcinoma patients who did not receive systemic treatment (including chemotherapy, targeted therapy and immunotherapy) before were enrolled in this study.
Platinum-based chemotherapy is the current standard of care (SOC) for locally advanced or metastatic urothelial carcinoma but has less favorable long-term efficacy. Urothelial carcinoma is the second indication of Disitamab Vedotin approved in China at the end of 2021 for the treatment of locally advanced or metastatic urothelial carcinoma patients with HER2 IHC 2+ or 3+, who received platinum-containing chemotherapy before. According to the clinical data for the initial BLA submission, the objective response rate (ORR) based on assessment by the Independent Review Committee reached 50.5%, the median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 14.2 months, demonstrating significant efficacy and clinical benefit. Another exploratory study of Disitamab Vedotin combined with PD-1 inhibitor also had remarkable results which have been reported by ASCO for several times. The phase 3 study based on the above clinical data will be helpful for the transition of Disitamab Vedotin from later-line treatment to first-line treatment, bringing better survival benefits for more patients.
