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

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Minimal residual disease • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies. (PubMed, ESMO Open) - "Trastuzumab-pkrb plus gedatolisib demonstrated a 43.2% response rate and manageable toxicity, supporting dual HER2/PI3K pathway targeting in heavily pretreated HER2-positive MBC."

Journal • P2 data • Breast Cancer • Diabetes • HER2 Breast Cancer • HER2 Positive Breast Cancer • Mucositis • Oncology • Solid Tumor • Stomatitis • PIK3CA • PTEN

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

Trastuzumab plus FOLFOX for HER2-positive biliary tract cancer refractory to gemcitabine and cisplatin: a multi-institutional phase 2 trial of the Korean Cancer Study Group (KCSG-HB19-14). (PubMed, Lancet Gastroenterol Hepatol) - P2 | "For HER2-positive biliary tract cancer, second-line or third-line trastuzumab biosimilar plus FOLFOX exhibited promising activity with acceptable toxicity, warranting further investigation."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pain • Solid Tumor • HER-2

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Mar 2026

Trial completion • Trial 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 | Trial primary completion date: Aug 2026 ➔ Dec 2026 | Trial completion date: Aug 2027 ➔ Dec 2027

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

UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2027 ➔ Apr 2028 | Trial primary completion date: Apr 2026 ➔ Apr 2027 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor 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 | Completed | Sponsor: Celltrion | Active, not recruiting ➔ Completed

Trial completion

Celltrion grows Europe share as cancer…drugs win tenders, scripts (Chosun Biz) - "The cancer drug 'Vegzelma' (bevacizumab) has expanded supply by winning a series of major public tenders in France. Supply is being carried out through public hospital group purchasing organizations such as UniHA, HACOM, and GRAPS, and it has recorded a majority market share in the local bevacizumab market. In the same market, 'Herzuma' (trastuzumab) and 'Truxima' (rituximab) are also continuing with tenders and supply."

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

Efficacy and safety of trastuzumab biosimilar CT-P6 plus SOX or CapeOX in HER2-positive advanced gastric cancer: a multicenter phase II KSCC-TROX study. (PubMed, Gastric Cancer) - No abstract available

Journal • P2 data • Gastric Cancer • Oncology • Solid Tumor • HER-2

Celltrion boosts Japan biosimilar lead as oncology shares surge (Chosun Biz) - "According to local data compiled by IQVIA and the company, as of Dec. last year, the metastatic colorectal cancer and breast cancer therapy 'Vegzelma (bevacizumab)' recorded a 58% market share in Japan....The breast and gastric cancer therapy 'Herzuma (trastuzumab)' posted a 76% share in the Japanese market during the same period."

Commercial • Colorectal Cancer • Gastric Cancer • HER2 Positive Breast Cancer

UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Celltrion biosimilars gain share in Australia and New Zealand (Korea Biomedical Review) - "According to IQVIA, as of the third quarter of 2025, the biosimilar Herzuma (trastuzumab), used to treat breast and gastric cancers, held more than 56 percent of the market in Australia....In autoimmune disease treatments, Celltrion’s Remsima (infliximab) and Remsima SC (subcutaneous formulation) hold a combined market share of 58 percent in Australia....Steqeyma (ustekinumab) reached a 12 percent market share within its first quarter of sales, based on IQVIA data."

Commercial • Ankylosing Spondylitis • Crohn's disease • Gastric Cancer • HER2 Positive Breast Cancer • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2025 ➔ Jun 2026

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

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center

Minimal residual disease • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. (PubMed, Breast Cancer Res Treat) - P=N/A | "Trastuzumab CT-P6 combined with pertuzumab and chemotherapy can be used in neoadjuvant treatment for HER2-positive early breast cancer, showing pCR rates comparable to the reference trastuzumab and without evidence of immunogenicity. Exploratory analyses of soluble HER2 and anti-trastuzumab CT-P6 antibodies did not demonstrate a significant association with pCR, although this possibility cannot be excluded. Their assessment contributes to the translational understanding of biosimilar integration into curative regimens."

Biomarker • HEOR • Journal • Observational data • Real-world evidence • Breast Cancer • Cardiovascular • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Stability of Therapeutic Monoclonal Antibodies During Infusion with Elastomeric Pumps Intended for Home-Based Therapy. (PubMed, J Pharm Sci) - "This study aimed to investigate the stability of two marketed antibodies, Erbitux (cetuximab) and Herzuma (trastuzumab), during infusion using an elastomeric pump. DLS and NTA data exhibited uniform particle sizes across samples, suggesting undetectable aggregation. Overall, findings support the technical feasibility of utilizing this combination of elastomeric pump and conditions for administration of cetuximab and trastuzumab, providing valuable insights into maintaining product stability outside traditional healthcare settings."

Journal • Infectious Disease • Novel Coronavirus Disease • Pain

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