ASCO GU|RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer
The NCT05297552 study explored the synergy between the targeted therapy and immunotherapy in the perioperative setting for MIBC. Specifically, it assessed the safety and efficacy of the novel combination therapy featuring DV, a HER2-targeting ADC drug initially developed by
In the NCT05297552 study, 47 eligible patients (10.6% with HER2 IHC 1+, 57.4% with IHC 2+, and 31.9% with IHC 3+) received the investigational neoadjuvant therapy, among whom 33 patients underwent radical cystectomy and pelvic lymph node dissection (RC + PLND). As of the data cut-off date on
- The pathological complete response (pCR) rate reached an impressive 63.6% (95% CI: 45.1% - 79.6%), nearly doubling that observed with traditional neoadjuvant chemotherapies (36%-42%). The pathological response rate was 75.8% (95% CI: 57.7% - 88.9%). The study showed that for patients with baseline clinical stage of T2N0, the postoperative pCR rate reached 85.7%. A pCR rate of 55.6% was also achieved in patients with other pathological subtypes of urothelial carcinoma at baseline. Patients benefited significantly regardless of PD-L1 positive/negative and regardless of HER2 expression status (IHC 1+/2+/3+), among whom the pCR rate stood at 84.6% for HER2 IHC 3+ patients.
- The 12-month event-free survival (EFS) rate of all patients who underwent radical cystectomy was 92.5%, and the 18-month EFS rate was 85.9%.
- The therapy exhibited a manageable safety profile. The incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was only 27.7%, notably lower than the traditional chemotherapy regimen (40%-50%), suggesting a favorable tolerability.
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