ESMO 2025 | RC48-C016: disitamab vedotin & toripalimab vs chemotherapy in HER2+ la/mUC
Andrea Necchi, MD, IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy, comments on interim findings from the Phase III RC48-C016 trial (NCT05302284) of disitamab vedotin plus toripalimab verus platinum-based chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). The combination significantly prolonged progression-free and overall survival, with higher response rates and a more favorable safety profile than chemotherapy. Benefits were consistent across subgroups, supporting disitamab vedotin plus toripalimab as a potential new standard for this patient population. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
Yeah, this is the ESMO meeting. We had the pleasure to discuss the LBA7, the data, the Chinese data with the combination therapy of an anti-PD-L1 ADC in combination with the immunotherapy in checkpoint inhibitor as compared to standard chemotherapy in front-line metastatic setting in patients with ER positive urothelial cancer. Results in terms of primary endpoint, co-primary endpoint with PFS and OS were clearly in favor of statistically significant and clinically meaningful in favor of the DVT combination...
Yeah, this is the ESMO meeting. We had the pleasure to discuss the LBA7, the data, the Chinese data with the combination therapy of an anti-PD-L1 ADC in combination with the immunotherapy in checkpoint inhibitor as compared to standard chemotherapy in front-line metastatic setting in patients with ER positive urothelial cancer. Results in terms of primary endpoint, co-primary endpoint with PFS and OS were clearly in favor of statistically significant and clinically meaningful in favor of the DVT combination. Interestingly, the effect size of DVT combination as compared to chemotherapy for PFS outcome and OS outcome was pretty much similar to that reported with EV-Pembro combination. So the next step would be to try to identify a little bit more which are the patients who may benefit more from DVT combination as compared to EV-Pembro combination. There is an issue of geographical viability and geographical availability of the drugs, but at least we have a newer therapeutic option for the patient adding to the EV-Pembrolizumab availability that is actually moving far beyond the data that has been seen historically with standard chemotherapy.
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