Trazimera (trastuzumab-qyyp) / Pfizer - LARVOL DELTA

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

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: Dec 2024 ➔ Jun 2025

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CD4 • ER • HER-2 • PGR

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CD4 • 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: Dec 2024 ➔ Jun 2025

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

SWOG S1613: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: Nov 2024 ➔ Nov 2025

Trial completion date • Breast Cancer • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • HER2 Breast Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer (clinicaltrials.gov) - P=N/A | N=31 | Terminated | Sponsor: Albert Einstein College of Medicine | N=132 ➔ 31 | Active, not recruiting ➔ Terminated; Interventional component of study terminated prior to full enrollment

Enrollment change • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Pertuzumab and Trastuzumab Biosimilars in Real-Life Association for the First-Line Treatment of HER2-Positive Metastatic Breast Cancer: the prospective, observational PETRA study (SABCS 2024) - "TBs used were Trazimera® in 39 patients (34.8%), Ontruzant® in 27 (24.1%), Herzuma® in 23 (20.5%), Ogivri® in 19 (17.0%), and Kanjinti® in 4 (3.6%). The majority of chemotherapy regimens were paclitaxel in 90 patients (80.4%), followed by docetaxel in 18 (16.1%) and vinorelbine in 4 (3.6%)... Trastuzumab biosimilars appear to be similar to Herceptin when combined with pertuzumab and chemotherapy in the first-line treatment of metastatic HER2-positive breast cancer. However, 13% of patients experienced a decrease in LVEF during follow-up, which is significant. Systematic and regular monitoring of cardiac toxicity is mandatory."

Clinical • Metastases • Observational data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Contemporary patterns of Medicare Utilization and Spending on Herceptin and its Biosimilars in Breast Cancer. (SABCS 2024) - "The six FDA approved Herceptin biosimilars are: Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi. There has been a significant decline in Herceptin utilization and spending, accompanied by a shift towards biosimilars; reflecting changing trends in HER2-positive breast cancer treatments. Kanjinti and Trazimera, in particular, experienced substantial increases in spending, dosage units, claims, and beneficiaries, indicating growing acceptance and usage. Despite these increases, total spending and claims for Herceptin remain higher than for its biosimilars."

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

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 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of Trastuzumab BS (clinicaltrials.gov) - P=N/A | N=150 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Sep 2025 ➔ Feb 2025 | Trial primary completion date: Sep 2025 ➔ Feb 2025

Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

ACCRU-GI-2003: Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Academic and Community Cancer Research United | Trial completion date: May 2029 ➔ Sep 2024 | Trial primary completion date: May 2025 ➔ Sep 2024

Metastases • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MSI • NRAS • PIK3CA

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CD4 • HER-2 • PGR