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

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Adrienne G. Waks | Recruiting ➔ Active, not recruiting | N=40 ➔ 28

Enrollment change • Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

DS8201-801: Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial. (clinicaltrialsregister.eu) - P1 | N=20 | Recruiting | Sponsor: Daiichi Sankyo Inc.

New P1 trial • Oncology • Solid Tumor

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study (clinicaltrials.gov) - P2 | N=462 | Active, not recruiting | Sponsor: Borstkanker Onderzoek Groep | Trial primary completion date: May 2022 ➔ Nov 2022

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

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study (clinicaltrials.gov) - P2 | N=462 | Not yet recruiting | Sponsor: Borstkanker Onderzoek Groep

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study (clinicaltrials.gov) - P2 | N=462 | Recruiting | Sponsor: Borstkanker Onderzoek Groep | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study (clinicaltrials.gov) - P2 | N=462 | Active, not recruiting | Sponsor: Borstkanker Onderzoek Groep | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2032 ➔ May 2032

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

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Adrienne G. Waks | Trial primary completion date: Nov 2026 ➔ Feb 2026

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

Preclinical Study Finds Subcutaneous Nanotrastuzumab Comparable to Herceptin HYLECTA in Minipig Model (BioPharm International) - "A preclinical study evaluating Nanoform’s nanoparticle-engineered formulation of trastuzumab demonstrated pharmacokinetic comparability and favorable tolerability relative to Herceptin HYLECTA in a 21-day Göttingen minipig model...According to the company, the data indicate that SC exposure comparable to a hyaluronidase-enabled product may be achievable using a nanoparticle suspension approach alone."

PK/PD data • Preclinical • Solid Tumor

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