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Onco-Summaries: Daily Oncology Updates at a Glance


21/05/2026










Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma (Ref)


China’s NMPA approved toripalimab + disitamab vedotin for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC)


Approval supported by the RC48-C016 Phase 3 trial, conducted at 74 centers in China, showing superior efficacy vs. gemcitabine + platinum chemotherapy


  • Median PFS: 13.1 vs 6.5 months (HR=0.36, p<0.0001)


  • Median OS: 31.5 vs 16.9 months (HR=0.54, p<0.0001)


  • ORR: 76.1% vs 50.2%


  • Duration of response: 14.6 vs 5.6 months












Kelun-Biotech's Phase III sac-TMT Trial meets Primary PFS Endpoint in First-Line Advanced TNBC (Ref)


The OptiTROP-Breast03 Phase III study of sacituzumab tirumotecan (sac-TMT) vs chemotherapy as first-line treatment for unresectable/metastatic TNBC met its primary endpoint of progression-free survival (PFS) at a prespecified interim analysis


  • PFS met with statistical significance: The interim analysis confirmed a statistically significant and clinically meaningful PFS improvement with sac-TMT monotherapy vs. chemotherapy.


  • OS data immature but trending positive: Overall survival follow-up continues per protocol; a positive trend is observed and further analyses are planned.


  • Safety profile consistent: No new safety signals were identified; results align with previously reported studies


Upcoming Milestones:


  • Kelun-Biotech plans to engage with China's Center for Drug Evaluation (CDE) on the regulatory pathway for sac-TMT in the first-line TNBC indication



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