Presentation (CTI)

OBJECTIVES: To systematically evaluate efficacy and safety of three Chinese pertuzumab biosimilars including QL1209, TQB2440, and HLX11, versus reference pertuzumab in HER2-positive breast cancer, and to indirectly compare biosimilars to support reimbursement and clinical decisions.
METHODS: Three biosimilars' phase III randomized, double-blind, parallel-controlled equivalence registration clinical trials published/reported between 2020 and 2026 were retrieved and included. The primary endpoint was total pathological complete response rate (tpCR); secondary endpoints included breast pathological complete response (bpCR), objective response rate (ORR), and adverse events. Risk ratios (RR) and 95% confidence intervals (CI) were pooled using a Mantel-Haenszel random-effects model, and indirect comparisons between biosimilars were performed using the Bucher method.
RESULTS: Three trials enrolling 1,905 randomized patients (918 biosimilar, 918 reference) met inclusion criteria; each trial met prespecified equivalence margins. Pooled RRs versus reference were 1.00 (95% CI 0.91-1.09) for tpCR, 1.00 (0.93-1.09) for bpCR, and 1.03 (0.98-1.08) for ORR. Safety pooled RRs were 1.00 for any treatment-emergent adverse event (TEAE), 0.99 for any treatment-related adverse event (TRAE), and 0.82 (0.65-1.03) for serious adverse events (SAE). Indirect comparisons showed numerically higher grade ≥3 TRAE for TQB2440 versus HLX11 (RR 1.25; 95% CI 0.88-1.78) and numerically higher SAE for QL1209 and TQB2440 versus HLX11 (RR 1.35 and 1.33; CIs included unity); no between-biosimilar differences were statistically significant.
CONCLUSIONS: All three biosimilars demonstrated efficacy and safety equivalence to reference pertuzumab on registrational endpoints, with no clinically meaningful efficacy differences among biosimilars. Numerical safety trends favoring HLX11 were not statistically significant. Evidence supports interchangeable use within pertuzumab-containing dual HER2 blockade regimens, with biosimilar selection primarily driven by price and supply considerations in health technology assessment.