CLINICAL TRIALS PROFILE FOR TUCATINIB

All Clinical Trials for TUCATINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01983501 ↗	A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer	Completed	Cascadian Therapeutics Inc.	Phase 1	2014-02-28	The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
NCT01983501 ↗	A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer	Completed	Seagen Inc.	Phase 1	2014-02-28	The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
NCT02025192 ↗	A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer	Completed	Cascadian Therapeutics Inc.	Phase 1	2013-12-31	The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.
NCT02025192 ↗	A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer	Completed	Seagen Inc.	Phase 1	2013-12-31	The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.
NCT02614794 ↗	A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer	Active, not recruiting	Cascadian Therapeutics Inc.	Phase 2	2016-01-28	This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
NCT02614794 ↗	A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer	Active, not recruiting	Seagen Inc.	Phase 2	2016-01-28	This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

Clinical Trial Conditions for TUCATINIB

Condition Name

Condition Name for TUCATINIB
Intervention	Trials
Breast Cancer	10
HER2-positive Breast Cancer	7
Metastatic Breast Cancer	4
Breast Neoplasms	3

Condition MeSH

Condition MeSH for TUCATINIB
Intervention	Trials
Breast Neoplasms	32
Colorectal Neoplasms	7
Adenocarcinoma	7
Neoplasm Metastasis	6

Clinical Trial Locations for TUCATINIB

Trials by Country

Trials by Country for TUCATINIB
Location	Trials
United States	319
Canada	23
Spain	17
Japan	11
Korea, Republic of	7

Trials by US State

Trials by US State for TUCATINIB
Location	Trials
California	19
Texas	19
Washington	14
Tennessee	14
New York	13

Clinical Trial Progress for TUCATINIB

Clinical Trial Phase

Clinical Trial Phase for TUCATINIB
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TUCATINIB
Clinical Trial Phase	Trials
Recruiting	20
Not yet recruiting	19
Completed	8

Clinical Trial Sponsors for TUCATINIB

Sponsor Name

Sponsor Name for TUCATINIB
Sponsor	Trials
Seagen Inc.	34
Seattle Genetics, Inc.	13
Cascadian Therapeutics Inc.	5

Sponsor Type

Sponsor Type for TUCATINIB
Sponsor	Trials
Industry	73
Other	38
NIH	4

TUCATINIB Market Analysis and Financial Projection

Tucatinib: Clinical Trials, Market Analysis, and Projections

Introduction to Tucatinib

Tucatinib is a highly selective, oral, reversible tyrosine kinase inhibitor that targets the human epidermal growth factor receptor 2 (HER2). It is approved for use in combination with trastuzumab and capecitabine for the treatment of advanced HER2-positive unresectable or metastatic breast cancer, and in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer[3].

Clinical Trials Update

HER2CLIMB and HER2CLIMB-02 Trials

The HER2CLIMB trial was pivotal in establishing the efficacy of tucatinib. This trial demonstrated that the addition of tucatinib to a regimen containing trastuzumab and capecitabine significantly improved progression-free and overall survival in heavily pretreated patients with HER2-positive breast cancer, including those with brain metastases. This led to the FDA approval of tucatinib in 2020[4].

The HER2CLIMB-02 trial further investigated the combination of tucatinib with trastuzumab emtansine (T-DM1). In this phase III trial, patients with unresectable locally advanced or metastatic HER2-positive breast cancer were randomly assigned to receive either tucatinib plus T-DM1 or placebo plus T-DM1. The results showed that tucatinib plus T-DM1 reduced the risk of disease progression or death by 24.1% compared to the placebo arm. For patients with brain metastases, this reduction was even more significant, at 36.1%[4].

CompassHER2 Trials

The CompassHER2 trials are ongoing and aim to determine if the combination of tucatinib and T-DM1 is superior to T-DM1 alone in preventing breast cancer relapses in high-risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. The primary objective is to assess the invasive disease-free survival (iDFS) in these patients[1].

Pharmacokinetics and Safety Profile

A population pharmacokinetic analysis of tucatinib in healthy volunteers and patients with HER2-positive metastatic breast or colorectal cancers revealed that tucatinib's pharmacokinetic profiles can be adequately described by a two-compartment model. The study found that tumor type significantly affects tucatinib bioavailability and clearance, with higher steady-state exposure in patients with HER2-positive metastatic breast or colorectal cancers compared to healthy participants. However, these differences were not considered clinically meaningful, and no dose adjustments are required based on the tested covariates[3].

The safety profile of tucatinib, as observed in clinical trials, includes higher rates of treatment-related side effects such as those related to liver and gastrointestinal function. These effects were manageable with monitoring and clinical intervention, although they resulted in a higher rate of dose adjustments and treatment discontinuation in the tucatinib arm[4].

Market Analysis

Market Players

The global market for tucatinib tablets is dominated by key players such as Seagen, Globela Pharma, and Everest Pharmaceuticals. These companies are driving the market through their robust product portfolios and strategic initiatives[2].

Market Segmentation

The tucatinib tablets market is segmented by type (50mg per tablet, 150mg per tablet) and application (hospital, clinic, other). This segmentation helps in understanding the diverse needs of different patient populations and healthcare settings[2].

Market Forecast

The global tucatinib tablets market is expected to grow significantly due to several factors, including the increasing prevalence of HER2-positive breast cancer and the aging population in key regions such as the US, Europe, Japan, and China. The market is forecasted in terms of revenue and volume, with a comprehensive analysis of company share, competitive landscape, growth factors, and trends[2].

Projections and Future Outlook

Growing Demand for HER2-Targeted Therapies

The HER2-positive breast cancer market is anticipated to grow due to the launch of new HER2-targeted agents in the early disease setting. Established disease management strategies using combinations of chemotherapy with Herceptin, Perjeta, and other tyrosine kinase inhibitors like lapatinib have already improved patient outcomes. The introduction of tucatinib and other emerging therapies is expected to further enhance treatment options and patient survival rates[5].

Expanding Indications

Tucatinib's approval for use in combination with trastuzumab and capecitabine, and its potential in combination with T-DM1, indicates a broadening of its therapeutic applications. Ongoing and future clinical trials may expand its indications to other types of cancers and patient populations, further driving market growth.

Competitive Landscape

The competitive landscape in the HER2-positive breast cancer market is dynamic, with several players vying for market share. Tucatinib, with its unique pharmacokinetic profile and clinical efficacy, is well-positioned to capture a significant share of this growing market.

Key Takeaways

• Clinical Efficacy: Tucatinib has shown significant clinical benefits in combination with other HER2-targeted therapies, improving progression-free and overall survival in patients with HER2-positive breast cancer.
• Pharmacokinetics: Tucatinib's pharmacokinetic profile is well-characterized, with tumor type being a significant covariate affecting its bioavailability and clearance.
• Market Growth: The global tucatinib tablets market is expected to grow driven by increasing demand for HER2-targeted therapies and an aging population.
• Competitive Position: Tucatinib is a key player in the HER2-positive breast cancer market, with potential for expanded indications and market share.

FAQs

What is tucatinib used for?

Tucatinib is used in combination with trastuzumab and capecitabine for the treatment of advanced HER2-positive unresectable or metastatic breast cancer, and in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer[3].

What are the main side effects of tucatinib?

The main side effects of tucatinib include those related to liver and gastrointestinal function, which are manageable with monitoring and clinical intervention[4].

Who are the main players in the tucatinib tablets market?

The main players in the tucatinib tablets market are Seagen, Globela Pharma, and Everest Pharmaceuticals[2].

What are the key findings of the HER2CLIMB-02 trial?

The HER2CLIMB-02 trial found that tucatinib plus T-DM1 reduced the risk of disease progression or death by 24.1% compared to the placebo arm, with a more significant reduction of 36.1% in patients with brain metastases[4].

What is the forecast for the global tucatinib tablets market?

The global tucatinib tablets market is expected to grow significantly, driven by increasing demand for HER2-targeted therapies and an aging population, with forecasts provided in terms of revenue and volume[2].

Sources

1. Yale Medicine: "The CompassHER2 Trials (Comprehensive Use of Pathologic Complete Response to Guide Further Therapy) - Full Text View - ClinicalTrials.gov"
2. Valuates Reports: "Global Tucatinib Tablets Market Research Report 2024"
3. PubMed: "Population Pharmacokinetic Analysis of Tucatinib in Healthy Volunteers and in Patients with HER2+ Metastatic Breast or Colorectal Cancers"
4. AACR: "Tucatinib Plus Trastuzumab Emtansine May Benefit Patients With Advanced or Metastatic HER2-positive Breast Cancer"
5. GlobalData: "Pharmapoint: HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2025"