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A HER2 ADC with a DNA-alkylating payload that beat chemotherapy in a phase 3 trial yet never reached the market, because eye and lung toxicity and a stronger rival arrived first.
Byondis' duocarmycin-payload HER2 ADC improved PFS over physician's choice in pretreated HER2+ metastatic breast cancer (TULIP, 2021; PFS 7.0 vs 4.9 months) but with frequent ocular toxicity (~78%) and ILD. The FDA issued a complete response letter in 2023; the EMA application was withdrawn in 2024. Trastuzumab deruxtecan's DESTINY-Breast03 result made its niche disappear.
Lesson: statistical significance is not enough when a competitor redefines the standard; payload toxicity profile decides whether an ADC survives.
Trastuzumab with seco-DUBA duocarmycin via cleavable Val-Cit linker; DNA alkylation. Connects to HER2.
1.Trastuzumab duocarmazine's antibody arm binds HER2 on the surface of the cancer cell.
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Query for this drug: (TITLE:"Trastuzumab duocarmazine" OR ABSTRACT:"Trastuzumab duocarmazine" OR TITLE:"SYD985" OR ABSTRACT:"SYD985") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab duocarmazine, not a curated reading list.
Shares HER2, HER2-positive breast cancer, Antibody-drug conjugate (ADC) and the tag failure.
Shares Failures are hidden, Antibody-drug conjugate (ADC) and the tag failure.
Shares Failures are hidden, Antibody-drug conjugate (ADC) and the tag failure.
Shares HER2 and the tag failure.
Shares Failures are hidden and the tag failure.
Shares Failures are hidden and the tag failure.
Shares HER2 and the tag failure.
Shares Failures are hidden and the tag failure.