CLINICAL TRIALS PROFILE FOR KANJINTI

Biosimilar Clinical Trials for KANJINTI

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Amgen	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	Arbeitsgemeinschaft fur Internistische Onkologie	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.
NCT03811418 ↗	A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer	Withdrawn	iOMEDICO AG	Phase 3	2019-01-01	This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.

All Clinical Trials for KANJINTI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00238420 ↗	Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer	Active, not recruiting	National Cancer Institute (NCI)	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.
NCT00770809 ↗	Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-12-01	This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. 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. 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
NCT01196390 ↗	Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer	Active, not recruiting	NRG Oncology	Phase 3	2010-12-30	This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.
NCT01196390 ↗	Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2010-12-30	This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.
NCT01275677 ↗	Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer	Active, not recruiting	NRG Oncology	Phase 3	2011-01-06	This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer 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. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

Clinical Trial Conditions for KANJINTI

Condition Name

Condition Name for KANJINTI
Intervention	Trials
Stage IIIC Breast Cancer AJCC v7	6
Stage IIIA Breast Cancer AJCC v7	6
Stage IIIB Breast Cancer AJCC v7	5
HER2/Neu Positive	4

Condition MeSH

Condition MeSH for KANJINTI
Intervention	Trials
Breast Neoplasms	13
Carcinoma	10
Adenocarcinoma	4
Urinary Bladder Neoplasms	2

Clinical Trial Locations for KANJINTI

Trials by Country

Trials by Country for KANJINTI
Location	Trials
United States	342
Canada	13
Ireland	7
Puerto Rico	4
Germany	1

Trials by US State

Trials by US State for KANJINTI
Location	Trials
Texas	10
Washington	9
North Carolina	9
Illinois	8
Florida	8

Clinical Trial Progress for KANJINTI

Clinical Trial Phase

Clinical Trial Phase for KANJINTI
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	5
Phase 1/Phase 2	4

Clinical Trial Status

Clinical Trial Status for KANJINTI
Clinical Trial Phase	Trials
Recruiting	8
Active, not recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for KANJINTI

Sponsor Name

Sponsor Name for KANJINTI
Sponsor	Trials
National Cancer Institute (NCI)	14
NRG Oncology	5
Mayo Clinic	2

Sponsor Type

Sponsor Type for KANJINTI
Sponsor	Trials
Other	16
NIH	14
Industry	6

Clinical Trials Update, Market Analysis, and Projection for KANJINTI

Last updated: October 29, 2025

Introduction

KANJINTI (biosimilar trastuzumab-anns) has emerged as a prominent biosimilar competitor in the oncology treatment landscape, primarily targeting HER2-positive breast cancer and stomach cancers. Developed by Amgen, KANJINTI aims to capitalize on the expanding biosimilar market following patent expirations of branded biologics like Herceptin (trastuzumab). This analysis provides a comprehensive update on KANJINTI's clinical trial status, assesses its market positioning, and projects future growth opportunities.

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Clinical Trials Update for KANJINTI

Regulatory Approval and Clinical Development

KANJINTI received FDA approval in May 2019 as a biosimilar to Herceptin. The approval was based on a comprehensive comparability study demonstrating equivalent safety, efficacy, and immunogenicity compared to the reference product [1].

Parallel to FDA approval, KANJINTI has secured regulatory approvals across multiple jurisdictions, including the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and health authorities in Canada, Australia, and South Korea. These approvals often hinge on robust analytical and clinical data demonstrating biosimilarity.

Clinical Trials and Studies

While biosimilars generally do not require extensive Phase III equivalence trials for approval, several comparative and post-marketing studies have been conducted:

• Post-authorization Confirmatory Studies: Post-approval, Amgen has undertaken real-world effectiveness and safety studies to reaffirm biosimilarity across diverse populations and treatment regimens. These include retrospective analyses and registry-based studies in oncology settings.

• International Comparative Trials: Some regions have mandated local biosimilar head-to-head trials to confirm efficacy and safety. While specific ongoing Phase III trials for KANJINTI are limited, amendments to existing studies are ongoing in certain markets to refine data.

• Extended Indications: KANJINTI has been included in broader oncology indications similar to Herceptin, such as adjuvant therapy for early-stage HER2-positive breast cancer and metastatic gastric cancers. Trials assessing its interchangeability and switchability between biosimilar and originator are also in progress, aiming to bolster confidence among clinicians and payers.

Clinical Outcomes

Real-world data collected from registry studies indicate that KANJINTI displays comparable efficacy (measured by overall response rates, progression-free survival), safety (notably infusion-related reactions and cardiotoxicity), and immunogenicity profiles to Herceptin. The studies highlight sustained biosimilarity over extended treatment durations, supporting its clinical utility.

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Market Analysis of KANJINTI

Market Position and Competition

The biosimilar trastuzumab market is highly competitive. Key competitors include:

• Ontruzant (Samsung Bioepis/Merck)
• Herzuma (Sobi)
• Kixitty (Celltrion)
• Trazimera (Pfizer)

KANJINTI distinguishes itself through early regulatory approval, broad global access, and strong manufacturing partnerships, securing a significant market share, particularly in North America and Europe.

Market Penetration and Adoption Drivers

• Pricing Strategies: Amgen has positioned KANJINTI at approximately 20-30% discount compared to Herceptin, effectively reducing treatment costs and encouraging adoption among payers and providers.

• Payer Reimbursement: Insurance formularies increasingly favor biosimilars, especially when cost savings are significant, expanding KANJINTI’s market penetration.

• Physician Acceptance: Growing confidence in biosimilarity, bolstered by extensive real-world data and regulatory endorsements, facilitates prescribing habits.

• Global Access: Strategic partnerships with distribution networks in emerging markets have enhanced access in regions where Herceptin's high cost limits wider use.

Market Challenges

• Brand Loyalty and Perception: Despite regulatory approvals, some clinicians remain cautious, preferring the original biologic due to long-term safety data.

• Regulatory Variability: Differing regional regulatory requirements for interchangeability and switchability influence prescribing patterns.

• Patent Litigation: Ongoing patent litigations—though largely settled—pose risks of market entry delays.

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Market Projections for KANJINTI

Growth Forecasts

The global biosimilar trastuzumab market is projected to grow at a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, driven by patent expirations, cost containment pressures, and expanding indications [2].

For KANJINTI specifically:

• Revenue Trajectory: Based on current adoption rates, KANJINTI could achieve $600 million to $1 billion in global sales by 2027. North America and Europe will constitute the majority of sales, with emerging markets contributing significantly as access expands.

• Market Share Expectations: The biosimilar could snag a 30-40% share in regions with active biosimilar adoption policies, primarily in Europe and the U.S., given regulatory approvals and competitive pricing strategies.

Strategic Opportunities

• Regulatory Expansion: Accelerating approvals in China and Latin America can unlock new revenue streams.
• Indication Expansion: Further trials for additional indications such as neoadjuvant therapy or combination regimens could drive incremental sales.
• Partnerships and Licensing: Collaborations with regional manufacturers can lower costs and facilitate market penetration.

Risks and Mitigation

• Regulatory delays or denials in key markets may temper growth.
• Competitive pricing from rivals and generics could erode profit margins.
• Cross-regional regulatory divergence could complicate harmonized approval pathways.

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Key Takeaways

• Regulatory Standing: KANJINTI has solid regulatory approval in major markets, with ongoing real-world data reinforcing its biosimilarity claims.
• Market Positioning: Amgen's strategic pricing and global partnerships have facilitated strong market adoption, positioning KANJINTI as a leading biosimilar trastuzumab.
• Growth Outlook: The biosimilar is poised for substantial growth, potentially reaching over $1 billion in annual sales within five years, contingent on market dynamics and regional approvals.
• Competitive Landscape: While competition is intense, KANJINTI’s early market entry and broad access strategies provide a competitive edge.
• Future Strategies: Expanding indications, accelerating regional approvals, and fostering physician confidence will be critical for sustained growth.

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FAQs

1. What is the current regulatory approval status of KANJINTI?
   KANJINTI is approved by the FDA, EMA, and several other global regulators for multiple indications, including HER2-positive metastatic breast cancer and gastric cancers.

2. How does KANJINTI compare to Herceptin in clinical efficacy?
   Clinical and real-world studies demonstrate that KANJINTI offers comparable efficacy, safety, and immunogenicity to Herceptin, fulfilling biosimilar approval requirements.

3. What are the main drivers of KANJINTI’s market success?
   Cost savings through competitive pricing, expanding global access, regulatory endorsements, and growing clinician confidence are pivotal.

4. Which regions are most promising for future KANJINTI growth?
   North America, Europe, and emerging markets such as Latin America and Asia present significant opportunities for expansion.

5. What challenges does KANJINTI face in maintaining its market position?
   Challenges include fierce competition, regional regulatory hurdles, clinician preferences, and pricing pressures. Strategic collaborations and continued evidence generation are vital.

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References

1. U.S. Food and Drug Administration. “FDA Approves KANJINTI (trastuzumab-anns) for HER2-Positive Breast Cancer and Gastric or Gastroesophageal Junction Adenocarcinoma.” May 2019.
2. Evaluate Pharma. “Biosimilars Market Analysis & Forecasts 2022–2027.”