Mark Pegram, MD
Patients with HER2-positive early or locally advanced breast cancer who were exposed to reference trastuzumab (Herceptin) lots with a marked downward shift in antibody-dependent cell-mediated cytotoxicity (ADCC) had worse outcomes than those not exposed to at least 1 shifted ADCC lot or those treated with its biosimilar (SB3).
“Although this exploratory analysis is limited in that it does not have sufficient power due to limited sample size and number of events, level of exposure is not defined, and follow-up is short, these results suggest a possible impact of ADCC on EFS or OS. Further long-term results will follow,” Pegram et al concluded.
- Pegram MD, Pivot X, Cortes J, et al. Event-free survival by ADCC status from a follow-up study comparing SB3 (trastuzumab biosimilar) with reference trastuzumab for HER2 positive breast cancer in neoadjuvant setting. Presented at: 2018 San Antonio Breast Cancer Symposium; December 5-8; San Antonio, Tx. Abstract P6-17-09.
- Kim S, Song J, Park S, et al. Drifts in ADCC-related quality attributes of Herceptin: impact on development of a trastuzumab biosimilar. MAbs. 2017;9:704-714.
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