Trazimera (trastuzumab-qyyp) / Pfizer - LARVOL DELTA

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: University of Nebraska | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Dec 2025

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

Incidence of hypersensitivity reactions in patients receiving trastuzumab biosimilars (SABCS 2025) - "Accordingly, MD Anderson Cancer Center updated its formulary from trastuzumab (Herceptin®) to trastuzumab biosimilars: trastuzumab-qyyp (Trazimera®) and trastuzumab-anns (Kanjinti®), with trastuzumab-qyyp designated as the preferred agent. The incidence and severity of HSRs were higher in patients receiving biosimilar trastuzumab products compared to the reference product. Data collection for patients without documented trastuzumab allergies is ongoing. Based on this analysis, a prospective study utilizing prophylactic medications is being planned."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • HER-2

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Oct 2025 ➔ Aug 2026

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

NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2025 ➔ Sep 2026

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

HERTHENA-Breast-01: Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov) - P1/2 | N=81 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 ➔ Apr 2030 | Trial primary completion date: Sep 2029 ➔ Apr 2030

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

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: University of Washington | N=16 ➔ 25

Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2 | N=6452 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Biomarker • Trial completion date • Trial primary completion date • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hormone Receptor Positive Breast Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Uterine Cancer • CD4 • MSI

CALGB-40601: Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery (clinicaltrials.gov) - P3 | N=305 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

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

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=315 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

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

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Jun 2025 ➔ Oct 2025

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

NCI-2016-00570: Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jun 2025 ➔ Oct 2025

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

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (clinicaltrials.gov) - P3 | N=3270 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (clinicaltrials.gov) - P3 | N=2014 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Jun 2025

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

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov) - P1 | N=17 | Terminated | Sponsor: Mayo Clinic | N=39 ➔ 17 | Suspended ➔ Terminated; funding - sponsor filing Chapter 11 bankruptcy

Enrollment change • Trial termination • Breast Cancer • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Marginal Zone Lymphoma • Mycosis Fungoides • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2026

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

Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=34 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2026 ➔ May 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ May 2025; <75% accrued

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

Variation in Provider Reimbursement for Biosimilars and Reference Biologics by Commercial Payers (ISPOR 2025) - " We used price data from Q1 2024 for three largest payers in San Francisco and Chicago areas, each for Herceptin (trastuzumab) and its biosimilars (Ontruzant, Herzuma, Ogivri, Trazimera, and Kanjinti). Drivers of reimbursement rates include terms of confidential contracts between manufacturers, payers, and providers, and incentives for providers to use less expensive biosimilars. Payer price transparency data offer a unique opportunity to understand how reimbursement incentivizes providers. It may be used to explore the impact of biosimilar competition on spending on trastuzumab products across commercial markets."

Reimbursement • US reimbursement

Cost-Efficiency Modeling of Conversion to Biosimilar Trastuzumab-qyyp in Early-Stage Breast Cancer in Medicare (ISPOR 2025) - "OBJECTIVES: Biosimilars to originator trastuzumab (Herceptin®), such as trastuzumab-qyyp (Trazimera™), can deliver substantial savings and/or expanded access to biologic therapies for patients with early-stage breast cancer (BC)...We modeled combination therapy with docetaxel, carboplatin, and trastuzumab (TCH), using costs derived from 2024 Average Sales Price (ASP)...These savings represent 41% and 82% reductions in cost vs. originator-based treatment, respectively, and exceeded savings from alternative biosimilars trastuzumab-anns, -dttb, -pkrb, and -dkst... TCH with trastuzumab-qyyp can achieve substantial cost savings relative to originator-based treatment, allowing reinvestment to treat a substantial number of additional patients with early-stage BC, or fund other costs of care in Medicare, on a budget-neutral basis."

Medicare • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real-World Evidence on Clinical Outcomes and Safety of Trastuzumab Biosimilar in Colombian Breast Cancer Patients (ISPOR 2025) - "Trastuzumab-qyyp demonstrated effectiveness in both mBC and eBC with manageable adverse events primarily being gastrointestinal symptoms and fatigue. Treatment discontinuation due to adverse events was infrequent."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov) - P2 | N=2175 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • ER • PGR

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (clinicaltrials.gov) - P3 | N=2014 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2025 ➔ Mar 2026

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

Safety and Efficacy of Trastuzumab BS (clinicaltrials.gov) - P=N/A | N=8 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | N=150 ➔ 8

Enrollment change • Trial completion • Gastric Cancer • Oncology • Solid Tumor • HER-2

SCHOLAR-2: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Population Health Research Institute | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jan 2025 ➔ Dec 2025

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

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov) - P1/2 | N=81 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=315 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2024 ➔ Dec 2025

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