RemeGen announced the latest clinical research results on disitamab vedotin (RC48) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Researchers tested disitamab vedotin and toripalimab in combination on patients diagnosed with locally advanced or metastatic urothelial carcinoma (la/mUC). The objective of the study was to determine the safety and efficacy of this treatment approach.
While the primary focus of the study was to evaluate the safety of disitamab vedotin, the researchers also conducted ancillary studies to determine the effectiveness of the treatment in managing urothelial carcinoma, while examining specific biomarkers in the tumour biopsies.
The combination of disitamab vedotin and toripalimab showed promising results in patients with advanced or metastatic urothelial carcinoma. No dose-limiting toxicity was observed. By the cutoff date of November 18, 2022, the confirmed Objective Response Rate (cORR) was 73.2%, including 9.8% Complete Response (CR).
In the HER2 IHC 3+/2+ and IHC 1+ subgroups, the confirmed ORRs were noted as 83.3% and 64.3% respectively. The median Duration of Response (mDOR) was observed to be 8.2 months. For treatment-naïve patients, the confirmed ORR stood at 76.0%. The Disease Control Rate (DCR) was reported at 90.2%.
This was coupled with a median Progression-Free Survival (PFS) of 9.2 months and a two-year Overall Survival (OS) rate of 63.2%.
“Treating locally advanced or metastatic urothelial carcinoma remains a substantial unmet clinical need,” stated Professor Guo Jun of Peking University Cancer Hospital, who is also the principal investigator of the study. “In clinical practice, we find that approximately 90% of la/mUC patients show HER2 expression at IHC 1+ or above. It is gratifying to showcase the updated long-term survival data at this year’s ASCO Annual Meeting, highlighting the impressive efficacy of disitamab vedotin across varied HER2 or PD-L1 expression levels.”