Phase 3 LILAC study sets standard for clinical evaluation of oncology biosimilars

Totality of Evidence Supporting the Use of ABP 980, a Trastuzumab Biosimilar: Practical Considerations

“…Finally, clinical safety and efficacy of ABP 980 were demonstrated in a randomized, multicenter, double-blind, comparative clinical study (LILAC) conducted in patients with early breast cancer (EBC) [ 15 , 16 ]. This patient population is considered to be a sensitive population in which to evaluate a trastuzumab biosimilar because of its homogeneity and minimal confounding factors such as prior treatments that may confound immunogenicity evaluation, line of therapy, disease burden, comorbidities, and risk of secondary cancers [ 17 – 19 ].…”

“…A total of 725 patients were randomized in the LILAC study to receive ABP 980 ( n = 364) or trastuzumab RP ( n = 361) plus paclitaxel (175 mg/m 2 every 3 weeks or 80 mg/m 2 once weekly for 12 cycles if that was the standard of care in that region) followed by surgery. The co-primary efficacy endpoints in this study were risk difference (RD) and risk ratio (RR) of pathological complete response (pCR) in breast tissue and axillary lymph nodes assessed at a local laboratory [ 15 , 16 ]. A central laboratory performed a sensitivity analysis of tumor samples in order to reduce inter-pathologist variability in response determination.…”