At the 2025 European Society of Medical Oncology (ESMO) Congress, held from October 17–21, results from the Phase III RC48-C016 study were presented, evaluating the combination of RemeGen Biosciences’ HER2 targeting antibody-drug conjugate Aidixi (disitamab vedotin) and PD-1 checkpoint inhibitor toripalimab for first-line metastatic bladder cancer.
At a median follow-up of 18.2 months, patients treated with the combination experienced a longer progression-free survival, the trial’s primary endpoint of 13.1 months compared to 6.5 months in the control chemotherapy arm. A benefit was observed in overall survival (OS), the study’s other primary endpoint, as the median OS in the combination arm was superior to the chemotherapy arm; 31.5 months compared to 16.9 months. The data was consistent across multiple prespecified subgroups, such as cisplatin-eligible and ineligible patients, and across HER2 expression levels. Of the patients who received the combination, 76.1% responded to treatment compared to 50.2% who received chemotherapy. In terms of safety, 55.1% of patients treated with the combination experienced a grade ≥3 adverse event compared to 86.9% in the control arm.
Go deeper with GlobalData
Access deeper industry intelligence
Experience unmatched clarity with a single platform that combines unique data, AI, and human expertise.
According to GlobalData’s patient-based forecast, Bladder Cancer: Eight-Market Drug Forecast and Market Analysis, Aidixi sales are projected to reach $113.6m by 2032 across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China) while toripalimab is forecasted at $47m in that year.
The study was held in Chinese locations and is unlikely to launch in markets outside China. The current standard of care in front-line metastatic bladder cancer is the Astellas’ nectin-4 antibody-drug conjugate Padcev in combination with Keytruda on the basis of the EV-302 study. Cross-trial comparisons have a limitation because the Padcev study was for an all-comers patient population. Nevertheless, the median PFS and objective response rate (ORR) in the Aidixi and toripalimab study are slightly higher than in the Padcev and Keytruda study, 13.1 versus 12.5 months and 76% versus 68%, respectively. Chinese oncologists may opt to dose HER2-positive metastatic patients with the Aidixi combination in the frontline setting and Padcev in second or later lines of therapy. Outside of China, the combination of Aidixi with Keytruda in the front-line setting is being investigated in a global Phase III study.
Editor’s note: In the second paragraph, reference to KEYNOTE-905 has been removed.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData
