KEY TAKEAWAYS
- The LB1802 trial aimed to evaluate the safety of trastuzumab biosimilar(named as Zedora in Brazil) in adjuvant HER2+ BC pts.
- The safety endpoint was to determine the occurrence of AEs.
- The study found that the types and severity of AEs observed were similar to those reported with trastuzumab.
Biosimilars are highly similar to approved reference products and have been approved for HER2+ breast cancer (BC) and advanced gastric cancer in Brazil. Researchers aimed to evaluate the safety of trastuzumab biosimilar(named as Zedora in Brazil) in adjuvant HER2+ BC patients (pts).
The study included pts who had early-stage HER2-positive BC and received at least one dose of a trastuzumab biosimilar as adjuvant therapy. They recruited 126 out of the planned 170 pts. This report presented the initial safety findings for the first 42 pts enrolled in the study. The safety endpoint was to determine the occurrence of AEs, and this involved all pts who received at least one dose of the trastuzumab biosimilar. They examined AEs from the moment of consent form signature until the conclusion of adjuvant treatment.
Among the 42 evaluated pts, baseline characteristics included a median age of 48.5 years, with 78.6% having node-negative disease. Most pts had hormone-receptor-positive tumors (71.4% estrogen-receptor-positive and 57.1% progesterone-receptor-positive). More patients (59.5%) underwent conservative surgery than mastectomy (40.5%). The most common type of breast cancer was invasive ductal carcinoma (97.6%). Most patients (68.8%) received neoadjuvant therapy, which included the administration of trastuzumab biosimilar and pertuzumab (68.8%) or trastuzumab biosimilar alone (25%). Only 6.3% of pts received the reference trastuzumab in neoadjuvant therapy. In total, 25/42 (59.5%) pts had at least one AE; 2 were serious AEs (4.8%). The occurrence of grade 3 or 4 AEs was 35.7%, and no death occurred.
The study found that the types and severity of AEs observed were similar to those reported with trastuzumab.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.e12524
Clinical Trial: https://clinicaltrials.gov/study/NCT03892655
Ana Carolina Ferreira Cardoso, Debora De Melo Gagliato, Natália Mesquita Brito, Maura Gonzaga Lapa, Érida Aparecida Pinto Magaton, Renata Virgínia Cavalcanti Santos, and Vivienne Carduz Castilho. DOI: 10.1200/JCO.2022.40.16_suppl.e12524 Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) e12524-e12524.
