Herzuma (trastuzumab-pkrb)

Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response. In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.

P3, N=912, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P1/2, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Phase classification: P1b --> P1/2 | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025

P2, N=130, Recruiting, Population Health Research Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare.

P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn

P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025

P2, N=16, Recruiting, University of Washington | Trial primary completion date: Oct 2023 --> Oct 2024

P2, N=42, Active, not recruiting, Korea University Guro Hospital | Recruiting --> Active, not recruiting

P2, N=42, Recruiting, Korea University Guro Hospital

P2; Not yet recruiting --> Recruiting

P2, N=36, Completed, Yonsei University | Recruiting --> Completed | Trial completion date: Mar 2023 --> Jun 2023 | Trial primary completion date: Sep 2022 --> Jun 2023

P3, N=900, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting | N=654 --> 900 | Trial completion date: Jun 2026 --> Apr 2027 | Trial primary completion date: Dec 2023 --> Dec 2024

Trastuzumab-pkrb plus paclitaxel demonstrates promising efficacy with manageable toxicity profiles in patients with HER2-positive recurrent or metastatic UC.

P1, N=25, Not yet recruiting, OHSU Knight Cancer Institute | Phase classification: P2 --> P1 | N=131 --> 25

P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2023 --> Oct 2023

P3, N=644, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. SDC shares morphological and histological similarities with invasive ductal carcinoma of breast, which led to an investigation of hormonal receptor and human epidermal growth factor receptor 2 (HER2)/neu expression status in SDC. In this study, patients with HER2-positive SDC were enrolled and treated with combination of docetaxel-polymeric micelle and trastuzumab-pkrb. Promising antitumor activities were shown with objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9 months, median duration of response of 6.7 months, and median overall survival of 23.3 months.

Conversely, there are prospective trials supporting the use of anti-HER2 therapy in patients with unresectable, recurrent, or metastatic HER2-positive SGC, including trastuzumab plus docetaxel, trastuzumab plus pertuzumab, trastuzumab-pkrb plus nanoxel, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-Dxd). T-DM1 or T-Dxd can be considered upon disease progression on trastuzumab-combination therapies, although these antibody-drug conjugates can also be used upfront. Future research should investigate predictive biomarkers, the combination of HER2 and androgen blockade, and the application of novel therapies from breast cancer.

P1, N=39, Suspended, Mayo Clinic | Trial completion date: May 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Apr 2025

Data from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years.

P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024

P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023

For HER2-positive biliary tract cancer, second-line or third-line trastuzumab biosimilar plus FOLFOX exhibited promising activity with acceptable toxicity, warranting further investigation.

Conclusions The combination of allogeneic NK therapy, Herzuma® and paclitaxel showed synergistic anticancer activity in HER2-low breast cancer preclinical model. This combination merits further clinical investigation in HER2-low breast cancer patients.

We investigated the efficacy and safety of a trastuzumab biosimilar, Herzuma®, in combination with treatment of physician's choice (TPC) in patients with HER2+ metastatic breast cancer (MBC) who had failed at least two HER2 directed chemotherapies.

Funding K-MASTER- This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI17C2206) KCSG Celltrion for Herzuma...Conclusions ERBB2, TP53 and PIK3CA mutations in ctDNA were associated with worse PFS of trastuzumab biosimilar and cytotoxic chemotherapy in our patients. Enrichment of HRD related gene mutations and newly detected variants in ctDNA may be related with the study drug resistance.

P2, N=130, Recruiting, Population Health Research Institute | Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Dec 2025

P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting

P1; Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2024

P1b, N=18, Not yet recruiting, Jonsson Comprehensive Cancer Center

Adding paclitaxel to these treatments increased their effectivity to a similar extent. Moreover, the costs of CT-P6-based treatments were reduced by 1474.07 €/patient. All together we provide pre-clinical and clinical evidence of the equivalence of CT-P6 in combination with pertuzumab and chemotherapy and suggest studying these combinations also in HER2 low/negative BC patients.

Biosimilar trastuzumab showed equivalent outcome to reference trastuzumab, with similar adverse events. Biosimilar trastuzumab can suitably and safely replace trastuzumab as a reference for the treatment of HER2-positive AGC.

P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2022 --> Jun 2023

P2, N=41, Active, not recruiting, Samsung Medical Center | Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2021 --> Sep 2022

P3, N=624, Recruiting, AstraZeneca

P1, N=24, Recruiting, University of Washington | Trial completion date: Feb 2022 --> Feb 2024 | Trial primary completion date: Feb 2022 --> Feb 2023

The similarity of the time-to-event analyses between CT-P6 and trastuzumab supports the equivalence in terms of efficacy established for the primary endpoint. CT-P6 was well tolerated, with comparable safety and immunogenicity to trastuzumab. ClinicalTrials.gov: NCT02162667 (registered June 13, 2014).

We identified patients with HER2-positive EBC (n=254) who had received neoadjuvant chemotherapy with RTZ or CT-P6, plus pertuzumab, carboplatin and docetaxel (TCHP) and untreated stage IV MBC (n=103) who had received palliative first-line treatment with RTZ or CT-P6, plus pertuzumab and docetaxel (THP) between May 2014 and December 2019. The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups. These real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.

We studied the effect of reference trastuzumab and CT-P6 in combination with pertuzumab and chemotherapy (paclitaxel) on cell proliferation by MTT and colony formation assays. According to our pre-clinical and clinical data, CT-P6 showed equivalent efficacy to reference trastuzumab when combined with pertuzumab and chemotherapy. Conclusion Here we provide scientific evidence supporting the use of CT-P6 in combination with pertuzumab in HER2+ BC p. We thereby intend to contribute to the promotion of biosimilars, since their use could potentially reduce the public healthcare costs and increase the accessibility to these agents.

We studied the effect of reference trastuzumab and CT-P6 in combination with pertuzumab and chemotherapy (paclitaxel) on cell proliferation by MTT and colony formation assays. According to our pre-clinical and clinical data, CT-P6 showed equivalent efficacy to reference trastuzumab when combined with pertuzumab and chemotherapy. Conclusion Here we provide scientific evidence supporting the use of CT-P6 in combination with pertuzumab in HER2+ BC p. We thereby intend to contribute to the promotion of biosimilars, since their use could potentially reduce the public healthcare costs and increase the accessibility to these agents.

We studied the effect of reference trastuzumab and CT-P6 in combination with pertuzumab and chemotherapy (paclitaxel) on cell proliferation by MTT and colony formation assays. According to our pre-clinical and clinical data, CT-P6 showed equivalent efficacy to reference trastuzumab when combined with pertuzumab and chemotherapy. Conclusion Here we provide scientific evidence supporting the use of CT-P6 in combination with pertuzumab in HER2+ BC p. We thereby intend to contribute to the promotion of biosimilars, since their use could potentially reduce the public healthcare costs and increase the accessibility to these agents.