Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) / Roche, Halozyme - LARVOL DELTA

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Daiichi Sankyo | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting

Enrollment closed

Optimizing neoadjuvant treatment in HER2-positive breast cancer: the role of HER2, HR, PD-L1 expression and regimen selection. (PubMed, Future Oncol) - "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."

IO biomarker • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Daiichi Sankyo

New P1 trial • Solid Tumor

Reinforced Polymer-Nanoparticle Hydrogels for Subcutaneous and Sustained Delivery of Trastuzumab. (PubMed, Adv Healthc Mater) - "Trastuzumab is included as a clinically relevant therapeutic antibody. These formulations delayed mAb release both in vitro and in vivo mice models, with a similar pharmacokinetic performance to the clinically approved Herceptin SC (Roche) formulation composed of trastuzumab with recombinant human hyaluronidase (rHuPH20)."

Journal • Oncology

CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - P2 | N=528 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2024

Trial completion • Trial completion date • Oncology

ATEMPT 2.0: Adjuvant T-DM1 vs TH (clinicaltrials.gov) - P2 | N=500 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: May 2025 ➔ Nov 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

The cost of convenience: Evaluating economic differences in SQ and IV biotherapeutic formulations. (ASCO 2025) - " SQ formulations of Rituximab (Rituxan Hycela), Trastuzumab (Herceptin Hylecta), and Daratumumab (Darzalex Faspro) became available in 2017, 2019 and 2020, respectively. While subcutaneous (SQ) formulations offer convenience and potential clinical and administrative benefits, they generally cost more than their IV counterparts. SQ Daratumumab was more readily adopted possibly due to fewer drug-related reactions, shorter administration duration, patient convenience, and lack of biosimilar options. Despite the higher costs, convenience and patient preference for SQ formulations may justify their use in certain clinical scenarios."

Oncology

Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER 2+ breast cancer in Morocco. (ASCO 2025) - "TZM was given as Monotherapy to 44% of patients in the IV group and 83% in the SC group; and in association with chemotherapy to 56% of IV patients and 17% of SC patients; combination therapy included TZM and Pertuzumab in 17% of IV patients and 2% of SC patients. The study demonstrated that the IV route appears more economically promising than the SC route, with a similar impact on the duration of care and quality of life. This data provides reassurance for a better therapeutic strategy for breast cancer, and they can be used in budgetary impact assessments on the Moroccan population subject to this disease."

Clinical • HEOR • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Celltrion | Not yet recruiting ➔ Recruiting

Enrollment open

The lymphatic system plays a major role in the absorption of subcutaneously administered trastuzumab in a lymph-duct cannulated rat model (AACR 2025) - "The study confirms the lymphatics is the main absorption pathway following subcutaneous administration of trastuzumab, regardless of the formulation type (IV or SC). This results in markedly high concentrations of trastuzumab in the draining lymphatics, and the co-localization of the drug molecules with potentially disseminated tumor cells and immune cells within the tumor-draining lymphatics may provide an opportunity for enhanced therapeutic outcomes."

Preclinical • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Solid Tumor

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Dec 2028 ➔ Nov 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant Therapy with Pyrotinib, Subcutaneous Trastuzumab, and Capecitabine for HER2-Positive Early Breast Cancer: A Prospective, Single-Arm, Multicenter Trial (SABCS 2024) - P2 | "This prospective, single-arm, multicenter trial will provide valuable insight into the efficacy and safety of a novel, fully non-intravenous neoadjuvant regimen combining pyrotinib, SC trastuzumab, and capecitabine for low- to intermediate-risk HER2-positive early breast cancer patients. If proven effective and well-tolerated, this regimen may offer a more convenient and less burdensome treatment option for this patient population, potentially improving quality of life and treatment adherence."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Switching to a Fixed-dose Combined Pertuzumab and Trastuzumab With Recombinant Human Hyaluronidase Subcutaneous Injection to Treat Human Epidermal Growth Factor Receptor 2-positive Breast Cancer in Real-world UK Clinical Practice. (PubMed, Clin Oncol (R Coll Radiol)) - "This initiative demonstrated the ability to rapidly and effectively transition >95% of eligible breast cancer patients from separate IV trastuzumab and pertuzumab to a fixed combined SC formulation. Patient benefits included shorter administration appointments and a less invasive form of treatment, whereas healthcare system benefits included substantial savings in aseptic preparation time and chair time, and a meaningful increase in clinic capacity. The reported treatment-switch process provides a model that can be adopted by other centres wishing to implement similar treatment switches."

Journal • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Celltrion

New P1 trial

Cost-minimization analysis comparing subcutaneous trastuzumab at home with intravenous trastuzumab for HER2-positive breast cancer in Singapore. (PubMed, Ther Adv Med Oncol) - "The cost reduction is approximately 60% compared to IV Herceptin regardless of disease status, with a 100% probability that the decision to adopt Homecare SC Herceptin leads to cost savings in Singapore. Treatment of breast cancer with Homecare SC Herceptin is a cost-saving option compared to IV Herceptin."

HEOR • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Clinical Review of Subcutaneous Trastuzumab and the Fixed-Dosed Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in the Treatment of HER2-Positive Breast Cancer (Clin Breast Cancer) - "Phase III trial results demonstrate that the efficacy and safety of SC trastuzumab and fixed-dosed combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for subcutaneous (PH FDC SC) injection and the intravenous (IV) formulation counterparts are comparable. SC formulations of anti-HER2 monoclonal antibodies offer several advantages over IV counterparts, including shorter administration time, less need for IV access, and better resource utilization for treatment facilities. This review summarizes the clinical data supporting the use of SC trastuzumab and PH FDC SC injection in treating early-stage and metastatic HER2-positive breast cancer and highlights the benefits of SC injection compared to the IV formulations."

Review • HER2 Positive Breast Cancer

Subcutaneous trastuzumab or intravenous biosimilar trastuzumab? Policy recommendation for breast cancer treatment in Malaysia (KSMO 2024) - No abstract available

Breast Cancer • Oncology • Solid Tumor

Huons Lab confirms Herceptin pharmacokinetics and diffusion effects with 'Hydifuse' [Google translation] (HIT News) - "Huons Lab...is accelerating the development of a subcutaneous injection (SC) drug formulation that improves patient convenience by utilizing recombinant human hyaluronidase (HyDIFFUZE...The research team added Hydifuse to Herceptin intravenous injection (HERCEPTIN IV), an antibody drug, administered it subcutaneously to animals, and compared it with Herceptin subcutaneous injection (HERCEPTIN SC) to which halozyme 'ENHANZE'...was added. As a result, the same pharmacokinetics (PK) and equivalent diffusion efficacy were confirmed...Huons Lab plans to submit an abstract for presentation of the non-clinical efficacy test results of Hydfuse, including the results of this trial, at the 2025 American Association for Cancer Research (AACR 2025)...According to a patent avoidance analysis (FTO) conducted by the law firm Padou Patent, the material patent for hyaluronidase held by Halozyme was confirmed to expire in September 2027 in the United States and in March 2024..."

Clinical data • Patent expiry • PK/PD data • Preclinical • Oncology

The burden of systemic therapy administration route in treating HER2-positive breast cancer (for patients, healthcare professionals, and healthcare system): a systematic literature review. (PubMed, Front Pharmacol) - "The observed preference for SC administration not only aligns with the imperative of adapting health systems to facilitate broad access to new cancer therapies but also underscores the importance of considering patient experiences and economic implications in shaping treatment strategies. These insights are crucial for healthcare policymakers, clinicians, and stakeholders in optimizing healthcare resources and enhancing the overall quality of BC care."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

New trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Subcutaneous versus intravenous administration of Trastuzumab: a minimization cost analysis with real world data from a reference cancer centre in Peru. (PubMed, Ecancermedicalscience) - "Cross-continental comparisons highlight a global trend favouring SC administration for efficiency and cost-effectiveness. The analysis provides insights for informed decision-making in resource-constrained healthcare settings like Peru, emphasising the need to consider local contexts in optimising oncology care."

Cost-analysis • HEOR • Journal • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Subcutaneous Trastuzumab: An Observational Study of Safety and Tolerability in Patients With Early HER2-Positive Breast Cancer. (PubMed, Int J Breast Cancer) - "Regional-specific studies may provide valuable insights into demographic factors influencing treatment outcomes in Peru or other countries. Furthermore, it could represent a more accessible alternative, potentially enhancing patient adherence and optimizing healthcare resource logistics."

Journal • Observational data • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Musculoskeletal Pain • Oncology • Solid Tumor • HER-2

Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer (clinicaltrials.gov) - P2 | N=109 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - P2 | N=528 | Active, not recruiting | Sponsor: Hoffmann-La Roche | N=790 ➔ 528

Enrollment change • Oncology