Herzuma (trastuzumab-pkrb) / Nippon Kayaku, Mundipharma, Celltrion, Teva - LARVOL DELTA

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

Comparative study of the impact of adjuvant trastuzumab and its biosimilars on cardiac function in HER2-positive early breast cancer patients: a single-center study. (PubMed, Front Oncol) - "This study evaluates the cardiac safety of Herzuma® and Kanjinti® compared with Herceptin® in a single-center cohort. While a higher event rate was observed in the Kanjinti® group, the small sample size limits interpretation. Prospective studies with longer follow-up and larger patient number are warranted to better characterize long-term cardiac outcomes."

Journal • Review • Breast Cancer • Cardiovascular • Congestive Heart Failure • Heart Failure • 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

Celltrion’s Vegzelma tops Japan’s bevacizumab prescriptions (Pulse by Maeil Business News Korea) - "According to market tracker IQVIA and local data, Vegzelma achieved a 50 percent market share as of last month, marking a more than threefold increase from 15 percent a year earlier. Celltrion’s Herzuma (trastuzumab), used to treat breast and gastric cancers, also continues to dominate with a 74 percent market share, maintaining a wide lead over competing products."

Commercial • Cervical Cancer • Colorectal Cancer • Gastric Cancer • Glioblastoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

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

Comparative Study of the Impact of Adjuvant Trastuzumab and Its Biosimilars on Cardiac Function in HER2-positive Early Breast Cancer Patients: A Single-Centre Study (Frontiers) - "Cardiac events occurred in 19 patients (Herceptin:18.6%, Herzuma: 19.4%, Kanjinti: 36.4%). No statistically significant differences in time to cardiac event were observed (log-rank p > 0.20). The odds ratio for events was highest in the Kanjinti group (vs. Herceptin, OR = 2.50, p = 0.24). Median time to event was shortest in the Kanjinti group. No significant associations between cardiac events and cardiovascular risk factors identified."

Retrospective data • HER2 Positive Breast Cancer

Celltrion expands footprint in Italy with continued wins for...oncology drugs (Korea Biomedical Review) - "These contracts have helped Truxima reach a 29 percent market share, Vegzelma 30 percent, and trastuzumab biosimilar Herzuma 29 percent, placing all three oncology products among Italy’s top-prescribed treatments in their classes...Additional tenders for these products are scheduled in the second half of the year."

Commercial • Cervical Cancer • Chronic Lymphocytic Leukemia • Colorectal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

Safety and efficacy evaluation of XP and Herzuma® combination chemotherapy for the first-line treatment of advanced gastric or GE junction adenocarcinoma patients (KSMO 2025) - No abstract available

Clinical • Metastases • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

The company announced on Aug. 28 that it has obtained sales approval for…Herzuma, a breast and gastric cancer treatment, in Vietnam, completing their launches…August of this year (Business Korea)

Launch non-US • Breast Cancer • Gastric Cancer

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

Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=109 | Completed | Sponsor: National Cancer Center, Korea | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive 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 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting

Enrollment closed

Celltrion’s Cancer Drug Herzuma Achieves 75% Market Share in Japan (Business Korea) - "Celltrion announced on June 13 that its breast and gastric cancer treatment Herzuma recorded a 75% market share in Japan as of April. According to pharmaceutical market research firm IQVIA and local market data, Herzuma has maintained the top position in prescriptions for four consecutive years since surpassing the market share of the original product for the first time in the second quarter of 2021....During the same period, Vegzelma, a treatment for metastatic colorectal and breast cancer, captured a 29% market share."

Commercial • Breast Cancer • Colorectal Cancer • Gastric Cancer

Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after 2 or more HER2-directed chemotherapies (KM-10A/KCSG BR18-13). (ASCO 2025) - P2 | "In this phase II study, the combination of trastuzumab-pkrb and gedatolisib demonstrated a 43.2% response rate with manageable toxicity in patients with HER2 positive MBC and PIK3CA mutations. A translational research study focused on the analysis of cfDNA and PBMC is currently being planned."

Clinical • Metastases • P2 data • Breast Cancer • Diabetes • HER2 Breast Cancer • HER2 Positive Breast Cancer • Mucositis • Oncology • Palliative care • Solid Tumor • Stomatitis • PIK3CA • PTEN

A multicenter randomized phase II study of trastuzumab biosimilar (CT-P6) and chemotherapy (SOX or CapeOX) in HER2-positive advanced/recurrent gastric cancer (KSCC: TROX study). (ASCO 2025) - "Funded by No funding sources reported Clinical Trial Registration Number: jRCTs071190007 Background: The efficacy and safety of the trastuzumab biosimilar (CT-P6) combined with S-1/oxaliplatin (SOX) or capecitabine/oxaliplatin (CapeOX) were investigated in patients with HER2-positive advanced or recurrent gastric cancer who had not previously received chemotherapy... Trastuzumab biosimilar (CT-P6) combined with SOX or CapeOX demonstrated robust antitumor efficacy and manageable toxicity in patients with advanced or recurrent gastric cancer."

Clinical • Metastases • P2 data • Anorexia • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

[ASCO 2025]Will the era of ‘PI3K’ targeted therapy open in HER2-positive breast cancer treatment? (Korea Biomedical Review) - P2 | N=15 | NCT03698383 | "According to the results of a Korean investigator-led phase 2 clinical trial presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (ASCO 2025) last Saturday (local time), the combination of trastuzumab biosimilar (Herzuma in trademark name) and PI3K/mTOR dual inhibitor gedatolisib showed significant antitumor effects in HER2-positive metastatic breast cancer patients with genetic abnormalities in the PI3K-AKT-mTOR pathway....Regarding genetic abnormalities, 26 patients reported PIK3CA kinase domain mutations, 11 PIK3CA helical domain mutations, one amplification, two PTEN deletions, and four other mutations. Of the 44 analyzable patients, two (4.5 percent) had a complete response (CR), and 17 (38.6 percent) had a partial response (PR), resulting in an objective response rate (ORR) of 43.2 percent and a disease control rate (DCR) of 86.4 percent."

P2 data • HER2 Positive Breast Cancer

Real-World Outcomes for HER2-Positive MBC: Exploring Global Perspectives and Regional Differences in Treatment Approaches (GBCC 2025) - "Real-World Data on Recently Approved Agents and HER2-Targeting Biosimilars Recent clinical trials have introduced several promising treatment options for HER2-positive MBC, including T-DXd, tucatinib, and T-DM1. Beyond their clinical trial efficacy, real-world studies support their effectiveness and tolerability in broader patient populations. Additionally, HER2-targeting biosimilars (e.g., Ontruzant, Herzuma) have gained widespread acceptance globally, and real-world evidence supports their comparable efficacy and safety in managing HER2-positive breast cancer."

Clinical • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Safety and Efficacy of Anti-Human Epidermal Growth Factor 2 Agents in the Treatment of Biliary Tract Cancers: A Systematic Review. (PubMed, JCO Precis Oncol) - "In patients with HER2-expressing BTCs, anti-HER2 therapies are viable options, particularly in the second-line setting."

Journal • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

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

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

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

Removal of Excipients from Drug Product may Impact Antibody Characterization of Monoclonal Antibodies. (PubMed, AAPS J) - "In this study, we elucidate this interference using Trastuzumab (Tmab) reference product, Herclon, and its commercially available biosimilars, Herzuma and Vivitra, as an example. The intrinsic fluorescence spectra displayed major wavelength maxima shifts of up to 6 nm. In view of these results, it is recommended that biosimilar manufacturers consider the impact of differences in formulation in the samples that are being compared as well as the impact of excipient removal, if they are extracting the therapeutic moiety from the drug product for comparability analysis (routinely done by biosimilar manufacturers)."

Journal

Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes. (PubMed, Oncol Ther) - "In this cohort study, CT-P6 demonstrated sufficient efficacy and no new safety concerns in HER2-positive advanced gastric cancer, serving as a cost-effective alternative to originator trastuzumab."

Journal • Real-world evidence • Breast Cancer • Cardiovascular • Coronary Artery Disease • Gastric Cancer • Heart Failure • HER2 Breast Cancer • HER2 Positive Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Celltrion ends Kern Pharma deal and begins direct sales of oncology biosimilars in Spain (Korea Biomedical Review) - "The company said Wednesday it finalized the termination of its partnership with Kern Pharma, and began selling its oncology drugs through its Spanish subsidiary this month. The local unit is initially marketing three biosimilars: Truxima (rituximab) for blood cancer, Herzuma (trastuzumab) for breast cancer, and Vegzelma (bevacizumab) for ​colorectal and breast cancers.....Celltrion said its Spanish subsidiary recently secured a contract with the 'Consortium of Health and Social of Catalonia (CSC),' one of Spain’s largest hospital procurement bodies, which supplies medicines to 25 public hospitals in the region. The deal covers Truxima and Herzuma for a four-year term through 2029."

Launch non-US • Licensing / partnership • Breast Cancer • Colorectal Cancer • Hematological Malignancies • Oncology