RE:RE:RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsRecently a SOLTI sponsored WoW clinical trial (TOT-HER3) with Daiichi Sankyo's Merck & Co. - partnered ADC patritumab deruxtecan (HER3-DXd) demonstrated that 96% of patients treated for HR+/Her2 negative breast cancer developed treatment-emergent adverse events (AEs) with 14% being grade ≥3; most common were nausea, fatigue, alopecia, diarrhea, abdominal pane and neutirophil count decrease.
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
ONCY's mBC Phase 3 registration- enabling clinical trial will enroll HR+/Her2 negative breast cancer patients who have failed one line of antibody-drug conjugate (ADC) therapy.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
https://www.fiercepharma.com/pharma/daiichis-lung-cancer-adc-rejected-fda-blow-first-project-under-merck-partnership