Hercessi (trastuzumab-strf)

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.

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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.

Taxane was the most commonly administrated chemotherapy regimen (n=51, 92.7%), including 56.4% albumin-bound paclitaxel, 20% liposomal paclitaxel and 18.2% docetaxel. The trastuzumab biosimilar HLX02 demonstrated comparable efficacy and safety to Herceptin when combined with pertuzumab and chemotherapy for Chinese patients with HER2-positive advanced breast cancer in real world first-line treatment, which suggested that HLX02 may provide another option of Her2-targeted therapy combined with pertuzumab for Chinese patients. The benefit regarding long-term survival need to be further verified. Table 1.

However, clinical equivalence studies between HLX02 and the original trastuzumab drug remain challenging. Future research should focus on the clinical exchange between biosimilars and original drugs, as well as the extrapolation of biosimilars' indications.

This study retrospectively collected clinical data of patients with early-stageHER2-positive breast cancer, who received trastuzumab, pertuzumab, docetaxel, and platinum as neoadjuvant therapy from November 2020 to July 2021. Adverse events (AEs) were observed in all patients, and the incidence of ≥3 grade AEs was comparable between the two groups (81.5% vs. 70.0%, p = 0.172). Zercepac has similar effectiveness and safety profile compared with reference trastuzumab in neoadjuvant therapy, which provides treatment options for patients with HER2-positive breast cancer.

The trastuzumab biosimilar drug HLX02 exhibited good treatment efficacy in HER2-positive gastric cancer, especially when combined with Endostar. IVIM-DWI can noninvasively monitor the process of vascular normalization and reflect the treatment effect early at the molecular level.

According to this real-world study, HLX02 in combination with pertuzumab as neoadjuvant therapy for HER2-positive breast cancer patients showed a similar pCR rate to that of dual-target neoadjuvant therapy reported in previous clinical trials. The treatment showed an encouraging effectiveness, and may become a novel neoadjuvant option for patients with HER2-positive breast cancer. The study was supported by the Natural Science Foundation of Shanghai (21ZR1414700).

At the willingness-to-pay threshold of $37,653/QALY in China, HLX02 is more cost-effective than trastuzumab. However, the relevant systems for the regulation of biosimilars still need to be improved.

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P3, N=649, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed

Among patients with HER2-positive recurrent or metastatic breast cancer, HLX02 demonstrated equivalent efficacy and similar safety and immunogenicity to reference trastuzumab.

Eligible female pts were recruited and randomized at a 1:1 ratio to receive an IV dose 8mg/kg of HLX02 or EU-TZB combined with docetaxel on Day 1 followed by 6mg/kg in 3-week cycle up to 12 month. Funding: Shanghai Henlius Biotech, Inc. Clinical trial identification: HLX02 phase I study: NCT02581748; HLX02 phase III study: NCT03084237.

P2; N=16; Not yet recruiting; Sponsor: University of Washington