Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):...in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable...in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease...in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin...in combination with neoadjuvant chemotherapy followed by adjuvant Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Zercepac is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).

The ORR24 was 71.3 and 71.4% in the HLX02 (n = 324) and EU-trastuzumab (n = 325) groups...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...The ORR was 71.3% (n=324) in HLX02 and 71.4% (n=325) in EU-TZB with the group difference of -0.1%,...Based on the evidence of equivalent efficacy, safety and PK of HLX02 and reference TZBs in HER2+ mBC pts resulted from phase III trial and popPK model, HLX02 possesses the potential to provide alternative treatment option for pts globally.

Eligible adult women with HER2+ breast cancer were randomised to 8 mg/kg of either HLX02 or EUTZB with docetaxel on Day 1 Cycle 1 followed by a dose of 6 mg/kg in 3weekly cycles for up to 12 months....Of the 649 patients being randomised (HLX02=324; EUTZB=325), the ORRwk24 (HLX02=71.0%; EU-TZB =71.4%; p = 0.952) and risk difference in ORRs (-0.4%; 95% CI: -7.4, 6.6) between the two groups were within the pre-defined margin (±13.5%).

Of 1046 patients enrolled, 649 were randomly allocated to receive HLX02 (n = 324) or EU-trastuzumab (n = 325). The ORR was 71.0% (230 of 324 patients; 95% CI: 66.0, 75.9) for HLX02 and 71.4% (232 of 325 patients; 95% CI: 66.5, 76.3) for EU-trastuzumab...Among women with HER2+ metastatic breast cancer, the use of HLX02 compared with EU-trastuzumab resulted in an equivalent ORR at Week 24...

23 female patients were included in our study with median age 62 (from 41 to 74). Primary diagnose was: localized disease 30.4% (n = 7), locally advanced 52.1% (n = 12), metastatic disease 17.3% (n = 4) of patients. Median disease free interval for initially localized and locally advanced disease patients was 48 months (from 8 to 132 months). Locoregional recurrence had 56.5% (n = 13) patients, visceral metastases 60.8% (n = 14), bone metastases 39.1% (n = 9), and mixed metastases had 52.1% (n = 12) of patients. Median number of cycles of trastuzumab is 83 (from 50 to 163), median period of time 62 months (from 36 to 143 months). Concomitant endocrine therapy had 52.1% (n = 12) of patients. Majority of patients 69.5% (n = 16) achieved complete remission, 21.7% (n = 5) of patients had a stable disease, 4.34% (n = 1) had a partial remission, and one patient had progressive disease...Majority of our patients had a good response to therapy, and continued with trastuzumab treatment, only one had a progressive disease.

"A 55-year-old postmenopausal woman with no family history of BC was admitted….n September 2020, the originator trastuzumab was replaced by the biosimilar Zercepac® (300 mg) because of the progressive disease and the lower price of biosimilars. Lung CT in December 2020 confirmed stable disease, with a CEA of 5.66 ng/ml."

A 53-year-old menopausal woman was admitted with a history of breast cancer operated 9 years ago and multiple metastases for 4 years….The patient was treated with docetaxel 130 mg and Zercepac® for nine cycles in a trial (NCT03084237, October 31, 2017 to August 17, 2018), followed by 9 cycles of maintenance Zercepac®. Overall, the best response was a partial response and the progression-free survival (PFS) was 26 months.

...we reported a young patient with a large HER2-positive BC achieved pCR after neoadjuvant therapy with TCbHP (docetaxel, carboplatin, Zercepac®, and pertuzumab)….The regimens were well tolerated by the case. In addition to providing a reference for the treatment of young BC patients with large masses, the results provide a good basis for applying biosimilars in the future.