CLINICAL TRIALS PROFILE FOR TUKYSA

All Clinical Trials for TUKYSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03043313 ↗	Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer	Active, not recruiting	Academic and Community Cancer Research United	Phase 2	2017-06-23	This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
NCT03043313 ↗	Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer	Active, not recruiting	Cascadian Therapeutics Inc.	Phase 2	2017-06-23	This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
NCT03043313 ↗	Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2017-06-23	This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
NCT03043313 ↗	Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer	Active, not recruiting	Seagen Inc.	Phase 2	2017-06-23	This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
NCT04430738 ↗	Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers	Recruiting	Seagen Inc.	Phase 1/Phase 2	2020-09-15	This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
NCT04430738 ↗	Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers	Recruiting	Seattle Genetics, Inc.	Phase 1/Phase 2	2020-09-15	This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).
NCT04512261 ↗	TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases	Recruiting	Merck Sharp & Dohme Corp.	Phase 1/Phase 2	2021-10-01	This is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2+ breast cancer brain metastases (BCBM). A total of 33 patients with untreated or previously treated and progressing HER2+ BCBM not requiring urgent central nervous system (CNS)-directed therapy will be enrolled. The study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling CNS disease in patients with HER2+ BCBM.

Clinical Trial Conditions for TUKYSA

Condition Name

Condition Name for TUKYSA
Intervention	Trials
Breast Cancer	6
HER2-positive Breast Cancer	4
Metastatic Colorectal Adenocarcinoma	2
HER2-positive Metastatic Breast Cancer	2

Condition MeSH

Condition MeSH for TUKYSA
Intervention	Trials
Breast Neoplasms	12
Colorectal Neoplasms	4
Carcinoma	3
Neoplasm Metastasis	3

Clinical Trial Locations for TUKYSA

Trials by Country

Trials by Country for TUKYSA
Location	Trials
United States	46
Spain	13
Japan	8
Korea, Republic of	1
Canada	1

Trials by US State

Trials by US State for TUKYSA
Location	Trials
California	6
Ohio	3
North Carolina	3
Colorado	3
Missouri	2

Clinical Trial Progress for TUKYSA

Clinical Trial Phase

Clinical Trial Phase for TUKYSA
Clinical Trial Phase	Trials
Phase 2	9
Phase 1/Phase 2	6
Phase 1	2

Clinical Trial Status

Clinical Trial Status for TUKYSA
Clinical Trial Phase	Trials
Not yet recruiting	10
Recruiting	6
Active, not recruiting	1

Clinical Trial Sponsors for TUKYSA

Sponsor Name

Sponsor Name for TUKYSA
Sponsor	Trials
Seagen Inc.	11
National Cancer Institute (NCI)	3
Academic and Community Cancer Research United	3

Sponsor Type

Sponsor Type for TUKYSA
Sponsor	Trials
Industry	22
Other	13
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Tukysa (Tucatinib)

Last updated: October 28, 2025

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Introduction

Tukysa (tucatinib), developed and marketed by Seattle Genetics and Genentech, is a targeted treatment for HER2-positive metastatic breast cancer. As a selective tyrosine kinase inhibitor, tucatinib blocks HER2 signaling pathways, providing a focused approach to combat aggressive breast cancer subtypes. This article provides a comprehensive update on clinical trials, analyzes current market dynamics, and projects future growth trajectories for Tukysa.

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Clinical Trials Overview and Recent Updates

Key Clinical Trials and Outcomes

Tukysa's clinical development has largely centered around its efficacy in HER2-positive breast cancer, especially in cases resistant to prior therapies. The pivotal HER2CLIMB trial (NCT02614790) remains a cornerstone, establishing higher overall response and survival rates when combined with trastuzumab and capecitabine versus standard therapy.

• HER2CLIMB Results (Published 2020): Demonstrated a 2.7-month improvement in median progression-free survival (PFS) and a 46% reduction in the risk of disease progression or death. Notably, it showed effectiveness in patients with brain metastases—a historically challenging subgroup.

• Ongoing Trials:

  • HER2DAT (NCT05266254) examines tucatinib in early-stage HER2-positive breast cancer, assessing its preventive potential post-surgery.
  • HER2EVO (NCT05105254) aims at assessing tucatinib in combination with other agents for metastatic disease, broadening therapeutic settings.

Recent Regulatory and Approval Actions

In 2020, the U.S. FDA granted accelerated approval for Tucysa in combination with trastuzumab and capecitabine for metastatic HER2-positive breast cancer in patients who have received at least two prior anti-HER2-based regimens. Subsequently, regulatory agencies in Europe and Japan authorized similar labeling, reflecting robust clinical efficacy data.

Safety Profile and Post-Market Surveillance

Tukysa generally exhibits a manageable safety profile, with diarrhea, hepatotoxicity, and palmar-plantar erythrodysesthesia being the most common adverse events. Post-market data continue to affirm its tolerability, contributing to clinical confidence and further real-world evidence collection.

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Market Analysis for Tukysa

Current Market Landscape

The global breast cancer therapeutics market was valued at approximately USD 9.7 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8%. HER2-positive subtypes represent roughly 20-25% of all breast cancers, indicating a sizable target population.

Key players include Pfizer's Ibrance, AstraZeneca's Enhertu, and Novartis's Kisqali—each with distinct mechanisms but competing for the HER2-positive niche. Tukysa's targeted action and efficacy in brain metastases give it a competitive edge, especially in heavily pretreated patient groups.

Market Penetration and Competitive Positioning

Since its approval, Tukysa has experienced steady adoption in metastatic settings. Its effectiveness against brain metastases fills a significant unmet need, enabling physicians to extend therapeutic options. The drug’s partnership model, through collaborations between Seattle Genetics and Roche's Genentech, bolsters its distribution and marketing momentum.

Intense clinical validation has resulted in expanding indications, including its potential application in earlier lines of therapy, which could significantly boost market share over the next 3-5 years.

Pricing and Reimbursement Factors

Tukysa's pricing aligns with other targeted therapies, with list prices around USD 15,000–18,000 per month in the U.S. Reimbursement decisions hinge upon the demonstration of cost-effectiveness, particularly given the high price point. Positive real-world outcomes and comparative effectiveness data will be crucial in expanding formulary inclusion and patient access.

Future Market Opportunities

• Expanding Indications: Continued trials exploring Tukysa in early-stage disease and combination regimens could unlock new revenue streams.
• Geographical Expansion: Market penetration in Asia-Pacific and Latin America, where breast cancer burden is increasing, offers substantial growth potential.
• Label Extension: Approval for other HER2-positive cancers, such as gastric or ovarian, remains under exploration, potentially broadening the market.

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Market Projection and Future Outlook

Based on current clinical momentum, regulatory landscape, and unmet needs, Tukysa’s global revenue is projected to grow at a CAGR of approximately 15-20% over the next five years. By 2028, sales could surpass USD 2 billion, driven by indications expansion and unmet medical needs in brain metastases.

Furthermore, innovations in combination therapies, including immune checkpoint inhibitors and novel antibody-drug conjugates, could augment its efficacy, positioning Tukysa as a backbone therapy in HER2-positive cancers.

As therapies move towards personalized medicine, Tukysa’s niche targeting HER2-positive subpopulations ensures sustained relevance amidst broader immunotherapy and chemotherapy options.

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Key Takeaways

• Clinical validation: HER2CLIMB trial outcomes reinforce Tukysa's efficacy, especially in patients with brain metastases, enabling regulatory approvals across multiple jurisdictions.
• Market positioning: Its unique benefits in heavily pretreated HER2-positive breast cancer secure its role against competitors, with potential to expand into earlier-stage disease.
• Growth drivers: Ongoing trials, geographic expansion, and label extensions present lucrative growth avenues.
• Strategic considerations: Price positioning and reimbursement support are critical to future adoption; real-world evidence will influence formulary decisions.
• Long-term outlook: Market projections affirm a promising trajectory, with sales likely to double through 2028 as indications and global access broaden.

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FAQs

1. What distinguishes Tukysa from other HER2-targeted therapies?
Tukysa's selectivity for HER2 and its proven effectiveness in treating brain metastases set it apart, offering a targeted option where others have limited CNS efficacy.

2. Are there ongoing trials for Tukysa in earlier lines of therapy?
Yes, trials like HER2DAT and HER2EVO aim to evaluate Tukysa in neoadjuvant, adjuvant, and early metastatic settings, potentially broadening its clinical application.

3. How does the safety profile of Tukysa impact patient compliance?
While common adverse events include diarrhea and hepatotoxicity, manageable through monitoring, their severity is generally mild to moderate, supporting adherence.

4. What strategies are Seattle Genetics and Roche implementing to expand Tukysa’s market?
Focus areas include expanding indications, pursuing global regulatory approvals, and developing combination regimens that enhance efficacy.

5. What is the outlook for Tukysa in non-breast HER2 cancers?
Early trials in gastric and ovarian cancers are ongoing, with promising preliminary data that could lead to future indications if efficacy and safety are confirmed.

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References

1. Murthy RK, et al. HER2CLIMB: a randomized trial of tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. J Clin Oncol. 2020.
2. Seattle Genetics. Tucatinib (Tukysa) Prescribing Information. 2022.
3. MarketWatch. Global breast cancer therapeutics market size and forecast. 2022.

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In summary, Tukysa’s robust clinical profile, strategic collaborations, and expanding indications poise it for sustained growth in the HER2-positive breast cancer landscape. Continuous clinical development and market expansion efforts will be key to unlocking its full commercial potential.