# The RC48-C016 trial drove China’s NMPA approval of toripalimab plus disitamab vedotin for first-line HER2-expressing urothelial carcinoma.

*biotech · news · 2026-05-24 · The Clinical Trial Vanguard*

## Key points

- The RC48-C016 trial showed toripalimab plus disitamab vedotin nearly doubled PFS and OS versus chemotherapy.
- The trial defined HER2 expression broadly as IHC 1+, 2+, or 3+, enlarging the eligible patient population.
- Disitamab vedotin plus toripalimab demonstrated a 76.1% ORR versus 50.2%, with response duration tripling to 14.6 months.
- Toripalimab's unique promotion of PD-1 receptor internalization may contribute to enhanced synergistic efficacy.
- The broad HER2 threshold used may face additional scrutiny if RemeGen and Junshi seek FDA approval.

**Companies:** RemeGen, Junshi
**Countries:** China

[Read the full story on The Clinical Trial Vanguard](https://www.clinicaltrialvanguard.com/news/china-approves-toripalimab-plus-disitamab-vedotin-for-her2-urothelial-cancer/)

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