Yantai, China,, February 15, 2025 / Prnewswire / – The morning of February 14, 2025 (UTC-8), at 2025 American Society of Clinical Oncology Genitounary Cancers Symposium (ASCO Gu) San Francisco,, USATeacher Xinan Sheng From Peking University Cancer Hospital Delivered the latest efficient and safety data from the Phase II Clinical Trial (NCT05297552, Study ID: RC48-C017) of Disitamab Vedotin (DV) in Combination Toripalimab as the Neoadjuvant Therapy for Her2-Expressing muscle-invasive cancer (MIBC) in an oral presentation. This marks the first public disclosure of the results of a prospective clinical study studying an ADC medication in combination with immunotherapy as perioperative therapy for MIBC. The complete pathological response rate (PCR) reached an impressive 63.6%, which is an improvement pierced compared to traditional neoadjuvant chemotherapy (36%-42%). Asco Gu is one of the best urological conferences in oncology than the main experts in the world in this area attend.
Study NCT05297552 explored synergy between targeted therapy and immunotherapy in the perioperative framework of MIBC. More specifically, it evaluated the safety and effectiveness of the new therapy combined with DV, an ADC drug targeting HER2 initially developed by Reilgen Co., Ltd. (Remengen), and Toripalimab, a PD-1 inhibitor. In May 2024Based on study NCT05297552, the Center for Drug Evaluation (CDE) of China The National Medical Products Administration (NMPA) has granted a designation of revolutionary therapy to DV. The preliminary results of this study were presented at the ASCO 2024 annual meeting and led to generalized attention and a discussion between experts from around the world. ASCO Gu updates have also validated the clinical advantages of this therapeutic approach.
In study NCT05297552, 47 eligible patients (10.6% with HER2 IHC 1+, 57.4% with IHC 2+ and 31.9% with IHC 3+) received neoadjuvant therapy sought and lymphatic dissection 33 ( RC + PLND). From the date of cutting data on December 3, 2024The study has shown promising efficiency and manageable security profiles:
- The complete pathological response rate (PCR) reached an impressive 63.6% (95% CI: 45.1% – 79.6%), almost that observed with traditional neoadjuvant chemotherapy (36% -42%) . The pathological response rate was 75.8% (95% CI: 57.7% – 88.9%). The study has shown that for patients with a basic T2N0 clinical stage, the postoperative PCR rate reached 85.7%. A 55.6% PCR rate was also reached in patients with other pathological subtypes of urothelial carcinoma at the start. Patients have benefited significantly regardless of the positive / negative PD-L1 and regardless of the HER2 expression status (IHC 1 + / 2 + / 3 +), among which the PCR rate was 84.6 % for HER2 IHC 3+ patients.
- The 12 -month event -free survival rate (EFS) of all patients who underwent radical cystectomy was 92.5%, and the 18 -month EFS rate was 85.9%.
- Therapy had a manageable security profile. The incidence of emerging undesirable events (Teaes) of grade 3 or higher or higher was only 27.7%, in particular lower than the traditional chemotherapy regime (40%-50%), which suggests favorable tolerability.
The Régen advances research on targeted and personalized therapies for bladder cancer by indication innovation and therapeutic innovation of DV, aimed at offering more powerful treatment options for patients in the world. Currently, studies are underway to explore the feasibility of expansion of DV regimes of the subsequent treatment to the front line line for locally advanced or metastatic uothelial cancer. It is also planned to expand the search for DV as neoadjuvant therapy for the MIBC at the whole perioperative period and to study synergy between DV and chemotherapy or other immunotherapy in the treatment of cancer of the uothelial .
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