Amol Akhade: New ADC plus IO Combo Challenges Frontline HER2+ Metastatic Urothelial Carcinoma Standard
Amol Akhade, Consultant Medical Oncologist at the Suyog Cancer Clinics, shared a post on LinkedIn:
“A new ADC plus IO combination challenges the frontline standard in HER2+ metastatic urothelial carcinoma.
A major announcement from RemeGen:
The RC48-C016 Phase 3 trial of Disitamab Vedotin (DV) + Toripalimab has met both primary endpoints – Overall Survival (OS) and Progression-Free Survival (PFS) – with statistical and clinical significance in HER2-expressing (IHC 1+, 2+, or 3+) locally advanced/metastatic urothelial carcinoma (la/mUC).
Key Highlights:
- OS and PFS benefit vs. standard gemcitabine + platinum
- Effective across HER2 expression levels (1+, 2+, 3+)
- Cisplatin-unfit patients included
- Manageable safety profile
- 484 patients, 74 centers across China
This marks one of the first ADC plus IO combinations targeting HER2-low bladder cancer in the first-line setting.
Why this matters:
The EV-302 trial firmly established Enfortumab Vedotin + Pembrolizumab as the new first-line standard in all-comer metastatic UC:
- OS: 31.5 months
- ORR: 67.7%, CR rate: 29%
But DV + Toripalimab may carve a biomarker-defined niche for HER2-expressing mUC-especially in cisplatin-ineligible patients.
What’s next?
- Full dataset to be presented at a major international oncology meeting (possibly ASCO25 or ESMO25)
- Biologics License Application (BLA) planned for submission
- Potential global impact if replicated beyond China
This is a bold step forward for HER2-targeted strategies in UC.
ADC plus IO continue to reshape solid tumor oncology.”
Amol Akhade highlighted the Phase 3 success of Disitamab Vedotin plus Toripalimab in HER2-expressing metastatic urothelial carcinoma. The RC48-C016 trial met both OS and PFS endpoints and may offer a new first-line option, particularly for cisplatin-ineligible patients. A full dataset will be presented at a major oncology meeting.
More posts featuring Amol Akhade.
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Challenging the Status Quo in Colorectal Cancer 2024
December 6-8, 2024
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ESMO 2024 Congress
September 13-17, 2024
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ASCO Annual Meeting
May 30 - June 4, 2024
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Yvonne Award 2024
May 31, 2024
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OncoThon 2024, Online
Feb. 15, 2024
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Global Summit on War & Cancer 2023, Online
Dec. 14-16, 2023