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

Subcutaneous versus intravenous trastuzumab for HER2-positive breast cancer: a global systematic review and meta-analysis with a cost-minimization analysis from the Chinese healthcare system perspective. (PubMed, Front Pharmacol) - "These findings are particularly relevant to healthcare systems where SC formulations are newly introduced, providing timely evidence to guide patient-centered clinical decision-making. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=637674, identifier CRD42025637674."

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

Reducing treatment burden in HER2+ breast cancer: Evaluating subcutaneous injection methods for pertuzumab/trastuzumab combination therapy. (PubMed, Medicine (Baltimore)) - "This retrospective analysis suggests that using a slow bolus injection with an infusion pump may reduce local adverse reactions following subcutaneous administration of pertuzumab and trastuzumab in patients with HER2-positive breast cancer. The standardized use of infusion pumps could enhance patient comfort, safety, and overall treatment experience."

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

Biocon Biologics to introduce three new biosimilar oncology assets (Business Standard) - "The company is set to unveil three new biosimilar oncology assets Trastuzumab/Hyaluronidase (Herceptin SC/Herceptin HYLECTA), Nivolumab (Opdivo), and Pembrolizumab (Keytruda) at the 2026 J.P. Morgan Healthcare Conference...Global sales of Keytruda were $29.5 billion in 2024"

Pipeline update • Sales • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Glioblastoma • HER2 Positive Breast Cancer • Melanoma • Myelodysplastic Syndrome • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer

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: Nov 2025 ➔ Jun 2026

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

Efficacy and Safety of Subcutaneous Pertuzumab-Trastuzumab (Phesgo) in Neoadjuvant Treatment of HER2-positive Breast Cancer: Real-world Data from Japan. (PubMed, Anticancer Res) - "Phesgo demonstrated comparable or superior efficacy and favorable safety with markedly improved treatment efficiency in real-world Japanese practice. Phesgo represents a promising alternative to intravenous administration, reducing patient burden and optimizing healthcare resource utilization."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Dermatology • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Musculoskeletal Pain • Oncology • Pruritus • Solid Tumor • HER-2

A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Biocon Limited

New P1 trial

A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov) - P1 | N=312 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov) - P1 | N=312 | Not yet recruiting | Sponsor: Genentech, Inc.

New P1 trial

Thrombospondin-4 from Cancer-associated Fibroblasts Downregulates ERBB2 Expression in Gastric Cancer Cells. (PubMed, Carcinogenesis) - "The effects of Herceptin or gabapentin, a THBS4 receptor inhibitor, on subcutaneous tumors were examined in nude mice...In vivo, CAFs suppress HER2 expression of subcutaneous GC tumors and induce Herceptin resistance...THBS4 from CAFs downregulated HER2 (ERBB2) expression in GC cells. Thus, THBS4 receptor inhibitors may be useful in preventing the acquisition of resistance to anti-HER2 therapy."

Journal • Gastric Cancer • Oncology • Solid Tumor • CAFs • HER-2 • THBS4

Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: National University Hospital, Singapore | Phase classification: P2 ➔ P1/2 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Phase classification • Trial primary completion date • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Subcutaneous versus intravenous routes in oncology: Preferences and impacts for patients and healthcare professionals (PubMed, Bull Cancer) - "This literature review highlights the significant benefits of using subcutaneous formulation versus intravenous formulation in oncology. Its usage is clearly favored by stakeholders, and it enables significant cost savings, further enhanced by the implementation of dedicated healthcare pathways."

Journal • Oncology

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