CLINICAL TRIALS PROFILE FOR ONTRUZANT

Biosimilar Clinical Trials for ONTRUZANT

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	National Cancer Institute (NCI)	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT04266249 ↗	CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 2	2020-02-11	This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT05036005 ↗	Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)	Recruiting	Samsung Bioepis Co., Ltd.	Phase 4	2021-07-11	The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity). Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.
NCT05036005 ↗	Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)	Recruiting	Institut fuer Frauengesundheit	Phase 4	2021-07-11	The treatment of patients with HER2 positive early breast cancer has continuously improved over the last decades. Up to now both, trastuzumab and pertuzumab are approved in combination with chemotherapy (CTX) not only for the adjuvant but also for the neoadjuvant treatment of early breast cancer patients. A high pCR rate in the neoadjuvant setting was shown in several trials and observational studies with CTX+ trastuzumab and with CTX+ pertuzumab. The efficacy is dependent on a variety of mechanisms including the blocking of the important PI3K/Akt and MAPK pathways, and ADCC (antibody dependent cellular toxicity). Recently the biosimilar Ontruzant® (SB3) has been introduced into the treatment of HER2 positive breast cancer as a biosimilar. Efficacy and toxicity have been shown to be equivalent to the first approved antibody, however, data from the real-world setting have not been published like it has for the originally approved antibody. Therefore, the aim of this study is to establish safety and efficacy for Ontruzant® in the real world setting. Patients can be included if they are treated with Ontruzant® in the neoadjuvant setting. Additionally, the study will be accompanied by a comprehensive immune monitoring program and biomarker program to explore immune oncology potential for the neoadjuvant treatment.

All Clinical Trials for ONTRUZANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Canadian Cancer Trials Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Cancer and Leukemia Group B	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	Southwest Oncology Group	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00005970 ↗	Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2000-05-19	This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
NCT00238420 ↗	Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer	Active, not recruiting	Radiation Therapy Oncology Group	Phase 1/Phase 2	2005-07-26	This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.

Clinical Trial Conditions for ONTRUZANT

Condition Name

Condition Name for ONTRUZANT
Intervention	Trials
Stage IIIA Breast Cancer AJCC v7	7
Stage IIIC Breast Cancer AJCC v7	6
Stage IIIB Breast Cancer AJCC v7	5
Stage IIIA Breast Cancer	5

Condition MeSH

Condition MeSH for ONTRUZANT
Intervention	Trials
Breast Neoplasms	15
Carcinoma	11
Adenocarcinoma	6
Esophageal Neoplasms	2

Clinical Trial Locations for ONTRUZANT

Trials by Country

Trials by Country for ONTRUZANT
Location	Trials
United States	426
Canada	14
Ireland	7
Germany	7
Puerto Rico	5

Trials by US State

Trials by US State for ONTRUZANT
Location	Trials
Washington	11
Texas	11
California	11
Minnesota	10
Florida	10

Clinical Trial Progress for ONTRUZANT

Clinical Trial Phase

Clinical Trial Phase for ONTRUZANT
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	7

Clinical Trial Status

Clinical Trial Status for ONTRUZANT
Clinical Trial Phase	Trials
Recruiting	11
Active, not recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for ONTRUZANT

Sponsor Name

Sponsor Name for ONTRUZANT
Sponsor	Trials
National Cancer Institute (NCI)	18
NRG Oncology	5
Jonsson Comprehensive Cancer Center	2

Sponsor Type

Sponsor Type for ONTRUZANT
Sponsor	Trials
Other	23
NIH	18
Industry	7

ONTRUZANT Market Analysis and Financial Projection

ONTRUZANT (Trastuzumab-dttb): Clinical Trials, Market Analysis, and Projections

Introduction to ONTRUZANT

ONTRUZANT (trastuzumab-dttb) is a biosimilar of the monoclonal antibody trastuzumab, which is used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer and metastatic gastric cancer. Developed by Samsung Bioepis, ONTRUZANT was approved by the FDA in January 2019 and is commercialized in the U.S. by Merck[1][3][4].

Clinical Trials and Efficacy

The approval of ONTRUZANT was based on a comprehensive data package that included extensive structural and functional analytical data, nonclinical and clinical pharmacokinetic data, and a comparative clinical study. This study demonstrated that ONTRUZANT is highly similar to its reference product, Herceptin, in terms of safety, purity, and potency.

Key Clinical Trial Findings

• The clinical trial supporting the biosimilarity of ONTRUZANT was one of the largest among biosimilars. It evaluated the efficacy of ONTRUZANT compared to Herceptin in patients with HER2-positive breast cancer.
• The study used a common dosing schedule for both ONTRUZANT and Herceptin, with treatments including docetaxel, fluorouracil, epirubicin, and cyclophosphamide.
• The primary endpoint was the pathologic complete response (pCR) in breast tumors. The results showed that the 95% confidence interval of the adjusted difference was within the predefined equivalence margin, indicating equivalent clinical efficacy between ONTRUZANT and Herceptin[4].

Indications and Usage

ONTRUZANT is indicated for the adjuvant treatment of HER2-overexpressing node-positive or node-negative (estrogen receptor [ER]/progesterone receptor [PR] negative or with one high-risk feature) breast cancer. It is also used as part of various treatment regimens, including those with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or with docetaxel and carboplatin. Patients must be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product[1][4].

Safety and Side Effects

Like other trastuzumab products, ONTRUZANT can cause serious and sometimes fatal side effects, including subclinical and clinical cardiac failure. The incidence and severity of these side effects are highest in patients receiving trastuzumab with anthracycline-containing regimens. Other potential side effects include infusion reactions and embryo-fetal toxicity[1][4].

Market Analysis

Current Market Landscape

The global trastuzumab biosimilar market is highly competitive, with several players including Amgen, Pfizer, Samsung Bioepis, Merck, Biocon, Mylan, BioXpress Therapeutics, Celltrion, Teva, and EirGenix. ONTRUZANT competes directly with other approved biosimilars such as Ogivri (developed by Mylan and Biocon) and Herzuma (developed by Celltrion and Teva)[2][3].

Pricing and Accessibility

ONTRUZANT is available in the U.S. at a lower cost compared to the reference product Herceptin. The prices for ONTRUZANT are approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial. This pricing strategy aims to make the treatment more accessible and affordable for patients[2].

Market Projections

Growth Drivers

The global trastuzumab biosimilar market is expected to grow significantly, driven by the rising prevalence of breast and gastric cancer, and the expanding pipeline of biosimilars. The market is forecasted to grow with a Compound Annual Growth Rate (CAGR) of 28.5% from 2024 to 2030[5].

Emerging Trends

Emerging trends in the trastuzumab biosimilar market include increased accessibility through hospital and online pharmacy markets. These trends are reshaping the future applications and dynamics of the market, making cancer treatment more accessible and affordable while maintaining high standards of care[5].

Market Segmentation

The global trastuzumab biosimilar market is segmented by product (e.g., ONTRUZANT, Ogivri, Herzuma) and by indication (adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer). This segmentation helps in understanding the specific market dynamics and opportunities for each segment[2].

Conclusion

ONTRUZANT has established itself as a viable and cost-effective alternative to Herceptin in the treatment of HER2-positive breast cancer and metastatic gastric cancer. With its robust clinical trial data and FDA approval, ONTRUZANT is poised to play a significant role in the growing trastuzumab biosimilar market.

Key Takeaways

• Clinical Efficacy: ONTRUZANT has demonstrated equivalent clinical efficacy to Herceptin in large-scale clinical trials.
• Market Competition: ONTRUZANT competes with other biosimilars like Ogivri and Herzuma in the global market.
• Pricing Strategy: ONTRUZANT is priced lower than Herceptin, making it more accessible to patients.
• Market Growth: The global trastuzumab biosimilar market is expected to grow significantly, driven by rising cancer rates and expanding biosimilar pipelines.
• Emerging Trends: Increased accessibility through various pharmacy channels is a key trend in the market.

FAQs

What is ONTRUZANT and how is it used?

ONTRUZANT (trastuzumab-dttb) is a biosimilar of the monoclonal antibody trastuzumab, used to treat HER2-positive breast cancer and metastatic gastric cancer. It is indicated for adjuvant treatment of HER2-overexpressing breast cancer and is used in various treatment regimens.

Who developed and commercializes ONTRUZANT?

ONTRUZANT was developed by Samsung Bioepis and is commercialized in the U.S. by Merck.

What are the potential side effects of ONTRUZANT?

ONTRUZANT can cause serious side effects including subclinical and clinical cardiac failure, infusion reactions, and embryo-fetal toxicity.

How does the pricing of ONTRUZANT compare to Herceptin?

ONTRUZANT is priced lower than Herceptin, with costs approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial.

What is the projected growth rate of the global trastuzumab biosimilar market?

The global trastuzumab biosimilar market is expected to grow with a CAGR of 28.5% from 2024 to 2030.

Sources

1. Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb)
   • Merck, April 15, 2020
2. Global Trastuzumab Biosimilars Market Report 2020-2030
   • Business Wire, May 5, 2021
3. FDA Approves Third Trastuzumab Biosimilar, Ontruzant
   • Center for Biosimilars, January 18, 2019
4. Equivalent Clinical Efficacy With ONTRUZANT® (trastuzumab-dttb)
   • Organon Pro
5. Trastuzumab Biosimilar Market Report: Trends, Forecast and Opportunities
   • Lucintel, November 25, 2024