Hercessi (trastuzumab-strf)

In patients with HR-HER2 + EBC, the neoadjuvant therapy with trastuzumab, pyrotinib and dalpiciclib has promising activity and manageable toxicity. Further investigation is needed.

HLX02 demonstrated favorable efficacy and safety in real-world practice comparable to those observed in previous HLX02 studies. Switching between trastuzumab originator and biosimilar for MBC treatment had no impact on efficacy and did not increase safety risks.

Background: The efficacy of HLX02, a trastuzumab biosimilar, in combination with chemotherapy for treating metastatic breast cancer (BC) has been established as equivalent to the reference Herceptin...Dual HER2 blockade with HLX02 and pertuzumab was associated with a numerically improved pCR rate (62.16%)...The lower pCR rate in HR-positive patients highlights the need for additional strategies. Combining CDK4/6 inhibitors with anti-HER2 therapy presents a promising approach for HR-positive HER2-positive patients, warranting further clinical validation.

The real-world data suggested that both HLX02 and RTZ, when combined with pertuzumab and various chemotherapy regimens, offer comparable efficacy and safety as first-line treatments for HER2-positive advanced breast cancer patients in China.

The intravenous formulation (Herceptin) or subcutaneous formulation (Herceptin Hylecta) of the original trastuzumab drug, as well as the biosimilar drugs (Hanquyou) produced in China, showed similar efficacy, while Nab-Paclitaxel demonstrated potential benefits in overall patient. HER2 3+, PD-L1 CPS > 27.5 and HR-negative are independent predictors of pCR. The TCbHP and THP regimens have comparable efficacy, and both are superior to the AC-THP regimen.

The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P＜0.05]. In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.

Long-term efficacy and safety were consistent with the previous findings. No clinically meaningful differences between HLX02 and reference trastuzumab were demonstrated.

Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.

These results suggested that the application of non-competing antibodies HLX22 and HLX02 targeting HER2 subdomain IV together may be of substantial benefit to gastric cancer patients who currently respond suboptimal to trastuzumab therapy.

80% and 15.5% patients had previously received pyrotinib/lapatinib and T-DM1, respectively. The treatment was well tolerated. The combination of trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy exhibited promising efficacy and a favorable safety profile as second- and beyond line treatment in HER2-positive metastatic breast cancer.

Adding HLX22 to HLX02 + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. Clinical trial information: NCT04908813. >*Hazard ratio (HR) was estimated between group A and C, as well as between group B and C. NE, not evaluable; NR, not reached.