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Last update 30 Dec 2025

Tucatinib

Last update 30 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Irbinitinib, Tucatinib (USAN/INN), 图卡替尼

+ [4]

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [4]

Active Indication

HER2 Positive Colorectal CancerMetastatic breast cancerHER2 Positive Breast Cancer+ [45]

Inactive Indication

Langer Mesomelic DysplasiaLiver Injury

Originator Organization

Array BioPharma, Inc.

Active Organization

Corden Pharma GmbH

Genentech, Inc.

MSD R&D (China) Co. Ltd.

+ [8]

Inactive Organization

Eli Lilly & Co.

Array BioPharma, Inc.

Cascadian Therapeutics LLC

License Organization

Eli Lilly & Co.

Seagen, Inc.

Merck & Co., Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (17 Apr 2020),

HER2 Positive Breast Cancer

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (Australia), Priority Review (United States)

Structure/Sequence

Molecular FormulaC26H24N8O2

InChIKeySDEAXTCZPQIFQM-UHFFFAOYSA-N

CAS Registry937263-43-9

Clinical Trials associated with Tucatinib

NCT07193394

/ Not yet recruitingPhase 2IIT

Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer: a Proof of Concept Study (H3RAKLES)

The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy. Patients included in this trial will have already received at least two lines of chemotherapy (and potentially several lines of endocrine therapy for patients with a HR+ disease). In this setting, few treatments have demonstrated a clinically meaningful benefit, and any additional option is valuable. Furthermore, the pre-clinical and clinical rationale indicate a high probability of clinical benefit, as previously shown in Table 1, with all patients treated with trastuzumab and a TKI targeting HER2 displaying a response. Besides, with several years of hindsight for the combination of lapatinib, trastuzumab and capecitabine, we expect excellent tolerance with the same treatment without capecitabine.
The H3RAKLES single-arm phase II trial will evaluate the combination of tucatinib, a HER2 TKI, and trastuzumab, a HER2-directed antibody in patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation. To demonstrate the actionability of ERBB3 mutations, all patients will receive a combination of trastuzumab and tucatinib, in 3-weeks cycles.

Start Date05 Dec 2025

Sponsor / Collaborator

Institut Curie

[+3]

CTIS2025-522128-28-00

/ Not yet recruitingPhase 1IIT

Study Investigating Tucatinib and Osimertinib Pharmacokinetics in Primary and Metastatic Brain Tumors: the STICK trial

Start Date01 Oct 2025

Sponsor / Collaborator-

NCT06961331

/ CompletedNot Applicable

Real-world Clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan for the Treatment of HER2-postive Metastatic Breast Cancer

A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g. time to next treatment, time to discontinuation, and overal survival) of the tucatinib-trastuzumab-capecitabine triplet therapy immediately following T-DXd therapy in patients diagnosed with HER2+ metastatic breast cancer (mBC) in the United States.

Start Date07 May 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Tucatinib

100 Translational Medicine associated with Tucatinib

100 Patents (Medical) associated with Tucatinib

317

Literatures (Medical) associated with Tucatinib

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Nov 2025·Lancet Regional Health-Europe

Real-world efficacy and safety of trastuzumab deruxtecan versus trastuzumab emtansine and tucatinib as second-line and third-line treatments for HER2-positive metastatic breast cancer: two target trial emulation studies

Article

Author: Haddy, Nadia ; Mansouri, Imène ; Desplas, David ; Zureik, Mahmoud ; Di Meglio, Antonio ; Jourdain, Hugo

Background:

The management of HER2-positive metastatic breast cancer (HER2⁺ mBC) has rapidly evolved. We assessed the real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) and tucatinib by emulating two phase III trials.

Methods:

We emulated two target trials using the French National Health Data System: T-DXd versus T-DM1 and T-DXd versus tucatinib, for second- and third-line HER2⁺ mBC treatment. We included patients from September 2020 to September 2023, and followed them until death or April 2024. We emulated treatment assignment randomization with inverse probability of treatment weighting. Efficacy outcomes included time to treatment discontinuation (TTD) and overall survival (OS). Safety outcomes included cause-specific hospitalizations.

Findings:

In the second-line treatment emulation (n = 2931: 1633 T-DM1, 1298 T-DXd), T-DXd had longer TTD (median 14⋅1 versus 6⋅5 months; weighted hazard ratio, wHR [95% confidence interval, CI], 0⋅46 [0⋅42-0⋅51]) and OS (median not reached; wHR [95% CI], 0⋅66 [0⋅55-0⋅80]) than T-DM1. We observed more cases of interstitial lung disease in the T-DXd group. In the third-line treatment emulation (n = 2391: 566 tucatinib, 1825 T-DXd), T-DXd had longer TTD (median 11⋅8 versus 5⋅8 months; wHR [95% CI], 0⋅60 [0⋅53-0⋅68]) and OS (median 31⋅7 versus 26⋅6 months; wHR [95% CI], 0⋅79 [0⋅69-0⋅92]) than tucatinib. T-DXd tended to protect from cardiac disorders (wHR [95% CI], 0⋅44 [0⋅26-0⋅74]) while enhancing respiratory disorders occurrence (wHR [95% CI], 1⋅72 [1⋅03-2⋅89]).

Interpretation:

In this real-world study, T-DXd was more effective than T-DM1 as a second-line treatment and tucatinib as a third-line treatment, in line with clinical trial results.

Funding:

None.

01 Nov 2025·JACC. Advances

Statin Use in Patients With Cancer

Article

Author: Chou, Emily ; Legasto, Carlo S ; Schulte, Brian C ; Chin, Alan K ; Baik, Alan H

BACKGROUND:

Cardiovascular disease and cancer share common risk factors. Statins, which are widely prescribed for cardiovascular disease prevention, have potential for drug-drug interactions (DDIs) with oncology agents.

OBJECTIVES:

This study quantifies and characterizes interactions between statins and recently approved oncology agents. Additionally, the study evaluates statin prescribing trends in patients with cancer.

METHODS:

Food and Drug Administration oncology drug approvals from June 2019 to June 2024 were screened for interactions with 5 commonly prescribed statins using UpToDate Lexidrug. Interaction severity was classified into 5 risk levels. Statin prescribing rates, stratified by cancer type, were characterized through a scoping review of 20 PubMed-indexed observational studies.

RESULTS:

Of 138 oncology agents, 33 (23.9%) exhibited DDIs with statins. Simvastatin demonstrated the highest interaction rate (22% [30/138] of oncology drugs), while pravastatin had the fewest (4% [5/138] oncology drugs). Most interactions (88%, 71/81) were classified as level C, requiring monitoring. Contraindicated interactions (level X) were identified for adagrasib, tucatinib, and asciminib. Across the 23,3774 patients in the included studies, statin use was most common in prostate (53%, 57,926/109,140 of patients) and lung cancer (32%, 1,403/4,344), and least common in liver (8%, 3,100/39,722) and breast cancer (10%, 1,519/15,078).

CONCLUSIONS:

Statin-oncology agent DDIs are relatively common but rarely is statin use contraindicated. Frequency of statins use varies according to cancer type. These findings highlight the importance of individualized risk-benefit assessments that consider prognosis, cardiovascular risk, potential drug interactions, and patient preferences to guide statin use in cancer patients.

151

News (Medical) associated with Tucatinib

18 Dec 2025

·www.drugs.com

San Antonio Breast Cancer Symposium, Dec. 9 to 12

The annual San Antonio Breast Cancer Symposium was held from Dec. 9 to 12 in San Antonio. Attendees included medical oncologists, radiation oncologists, researchers, and other health care professionals. The conference highlighted recent advances in the risk, diagnosis, treatment, and prevention of breast cancer , and presentations focused on emerging treatments in hard-to-treat patient populations, including patients with metastatic breast cancer . As part of the HER2CLIMB-05 study, Erika Hamilton, M.D., of the Sarah Cannon Research Institute in Nashville, Tennessee, and colleagues found that adding tucatinib to standard trastuzumab and pertuzumab (HP) maintenance in a first-line human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer setting prolongs disease control. The authors randomly assigned 654 patients with HER2-positive advanced breast cancer who completed four to eight cycles of induction chemotherapy plus HP without disease progression to receive either tucatinib or a placebo with continued HP. The aim of the study was to determine if the benefit patients receive from first-line maintenance therapy could be extended by adding tucatinib to HP after taxane induction. The researchers found that adding tucatinib to standard HP maintenance extended progression-free survival (PFS) by 8.6 months, a significant amount of time for patients living with metastatic disease. The benefit was consistent across key subgroups, including patients with hormone receptor-positive and hormone receptor-negative disease, with and without brain metastases. The safety profile was manageable, with the expected tucatinib-related liver enzyme elevations and manageable diarrhea. "We are essentially seeing a chemotherapy-free strategy that helps patients remain on treatment longer before their disease progresses. While the overall survival data are not yet mature, the consistency of the PFS benefit makes this an important finding for HER2-positive metastatic breast cancer," Hamilton said. "Right now, tucatinib is used in later-line settings, so this represents a potential future shift where we may be able to offer patients a strategy to prolong the maintenance phase of first-line therapy by not only delaying disease progression but also prolonging time off cytotoxic chemotherapy. If approved, this could broaden how we think about maintenance therapy for HER2-positive metastatic breast cancer." The study was funded by Seagen (acquired by Pfizer), which manufactures tucatinib. Press Release As part of the phase 2 ENHANCE clinical trial, Jun J. Mao, M.D., of the Memorial Sloan Kettering Cancer Center in New York City, and colleagues found that both real and sham acupuncture improve breast cancer survivors' perceived cognitive impairment compared with usual care alone, with real acupuncture demonstrating a more significant benefit compared to sham acupuncture. The authors conducted a randomized clinical trial comparing acupuncture against usual care and sham acupuncture (a procedure mimicking acupuncture without needle penetrating the skin, nor using classic acupuncture points). Patients received 10 weekly acupuncture treatments and then were followed for an additional 16 weeks off treatment. Patient perception of cognitive difficulty was evaluated using survey data, and objective cognitive function was evaluated using standardized tests. The researchers demonstrated that both real and sham acupuncture led to a clinically meaningful benefit for perceived cognitive difficulties when compared to usual care. Meanwhile, real acupuncture was significantly better than sham in improving objective cognitive function. "For women with breast cancer, real acupuncture can improve both subjective perception of cognitive difficulties and objective cognitive function," Mao said. "The process of receiving acupuncture (i.e., engaging in a therapeutic process and being heard, validated, and cared for) contributes to improved subjective perception; the specific needling of our acupuncture protocol can improve objective cognitive function." Press Release Joanne Kotsopoulos, Ph.D., of the Dalla Lana School of Public Health at the University of Toronto , and colleagues evaluated the impact of menopausal hormone therapy (MHT) use on breast cancer risk among women with a BRCA1 or BRCA2 mutation who were unaffected by cancer and had two breasts intact. The authors leveraged a large database and conducted an analysis of MHT use and BRCA -breast cancer, with the goal of generating evidence specifically for this high-risk group. Women who did and did not initiate MHT after menopause (mostly surgical) were followed prospectively for disease incidence. Overall, the researchers found that use of any type of MHT was associated with a lower risk of breast cancer (an inverse association) compared to women who did not use MHT. In the analysis stratified by type of formulation, the inverse association was strongest with use of estrogen-alone MHT. There was no association (no increase or decreased risk) seen with estrogen + progestogen MHT. Findings were similar for BRCA1 and BRCA2 carriers. "This adds to the body of literature on the topic. We need to ensure that we apply an evidenced-based approach to managing this high-risk population postoophorectomy. Unless contraindicated for another reason, MHT appears to offer a safe approach to manage the acute and longer-term sequelae of oophorectomy," Kotsopoulos said. "We should continue to take a personalized approach with all women who have entered very early menopause with the goal of ensuring a long and healthy life." Press Release SABCS: Risk-Based Screening Noninferior for Identifying Stage ≥IIB Breast Cancer WEDNESDAY, Dec. 17, 2025 -- Risk-based screening, including genetic testing, is noninferior to annual screening for detecting stage ≥IIB cancers and does not reduce biopsy rates despite fewer mammograms, according to a study published online Dec. 12 in the Journal of the American Medical Association to coincide with the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: New Endocrine Therapy, Giredestrant, Cuts Breast Cancer Recurrence TUESDAY, Dec. 16, 2025 – Giredestrant, a selective estrogen receptor antagonist and degrader given as an adjuvant therapy, shows significant improvement in invasive disease-free survival in patients with early-stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: Acupuncture Beneficial for Cognition in Breast Cancer FRIDAY, Dec. 12, 2025 -- For women with a history of breast cancer, real and sham acupuncture produce clinically meaningful improvements in perceived cognitive impairment, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: mHealth Intervention Improves QoL in Adolescent, Young Adult Breast Cancer Survivors FRIDAY, Dec. 12, 2025 -- For adolescent and young adult breast cancer survivors, a scalable mobile health intervention improves quality of life and reduces specific symptoms, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: Menopausal Hormone Therapy Does Not Increase Breast Cancer Risk in BRCA Carriers FRIDAY, Dec. 12, 2025 -- Use of menopausal hormone therapy following menopause is not associated with an increased risk for breast cancer among BRCA1 and BRCA2 carriers, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: Breast MRI Does Not Increase Local Regional Control in Some Early-Stage Breast Cancers THURSDAY, Dec. 11, 2025 -- Breast magnetic resonance imaging for local staging and surgical planning does not improve local regional control among patients with early-stage triple-negative and human epidermal growth factor 2-positive breast cancer, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text SABCS: Omission of SLNB Safe in Clinically T1-2 Node-Negative Breast Cancer THURSDAY, Dec. 11, 2025 -- For patients with clinically T1-2 node-negative breast cancer, the omission of sentinel lymph node biopsy results in noninferior five-year regional recurrence rates and regional recurrence-free survival, according to a study presented at the annual San Antonio Breast Cancer Symposium, held from Dec. 9 to 12 in San Antonio. Read Full Text

Clinical ResultPhase 2

11 Dec 2025

·www.biospace.com

Pfizer Builds Case for Tukysa as ‘New Standard Regimen’ in First-Line Metastatic Breast Cancer

iStock, Alexandros Michailidis While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.” Pfizer’s oral kinase inhibitor Tukysa significantly cut the risk of death or disease progression in patients with metastatic breast cancer in the frontline setting. Tukysa’s performance in this indication positions it to “become a new standard regimen” in HER2-positive metastatic breast cancer, analysts at BMO Capital Markets said in a Wednesday note. “Results today are a positive advancement. . .demonstrating more upside from expansion in oncology in the near term,” they added. The Phase III trial was not without its setbacks, however, as BMO noted liver toxicities. BMO considered the incidence of liver toxicity to be “meaningfully higher” with Tukysa treatment, something they expect doctors to take into account when deciding whether to prescribe the regimen. Still, “We expect most physicians to be comfortable with this risk trade-off,” the analysts wrote, “as efficacy outcomes appear to more than make up for any safety concerns.” In the HER2CLIMB-05 study, Pfizer tested a combination of Tukysa and Roche’s Herceptin and Perjeta in more than 320 patients with HER2-positive metastatic breast cancer who had undergone pre-study induction treatment with Herceptin, Perjeta and taxane, and had shown no sign of disease progression thereafter. Patients in the control arm were treated with just Herceptin and Perjeta. Results, announced Wednesday and presented at the 48th San Antonio Breast Cancer Symposium (SABCS), showed the Tukysa-based combo cut the risk of disease progression or death by 35.9% versus controls. Median progression-free survival (PFS) hit 24.9 months in the Tukysa arm, versus 16.3 months for comparators. Overall survival, which was immature at the time of the readout, leaned numerically in favor of Tukysa. Pfizer also noted that Tukysa’s PFS benefit remained consistent across different patient subgroups, including those with recurrent or de novo diagnoses, with or without brain metastasis and whose disease was either HR-positive or HR-negative. “Improvements in PFS of this magnitude are clearly significant and clinically meaningful,” BMO added in its note, “potentially opening the opportunity for [Tukysa] to be added as a standard 1L treatment option.” Data from HER2CLIMB-05 also revealed potential safety concerns, including a higher rate of grade 3 and higher elevations in liver transaminases—though Pfizer insisted these were “typically manageable and reversible” with dose modifications. More detailed data published in the Journal of Clinical Oncology showed that 13.5% of patients dropped out due to treatment-emergent adverse events.

Clinical ResultPhase 3

10 Dec 2025

·www.fiercepharma.com

Pfizer's Tukysa delays HER2 breast cancer progression as 1st-line maintenance therapy

Addition of Tukysa to standard first-line maintenance therapy for patients with HER2-positive breast cancer offers an opportunity to prolong time to disease progression or death. Pfizer has rolled out detailed trial data suggesting Tukysa could be part of a new first-line treatment to delay the progression of HER2-positive breast cancer.The current standard of care for the disease includes induction chemotherapy in combination with Roche’s Herceptin and Perjeta, followed by a chemo-free maintenance phase with the two HER2 antibody drugs. Now, Pfizer has shown that adding Tukysa during the maintenance stage can improve patient outcomes.Specifically, addition of Tukysa to first-line maintenance therapy significantly reduced the risk of progression or death by 35.9%, according to investigator-assessed results from the phase 3 HER2CLIMB-05 trial, which were presented at the San Antonio Breast Cancer Symposium. Patients who received the Pfizer small molecule went 8.6 months longer without tumor progression, reaching 24.9 months at the median.The drug’s progression-free survival (PFS) benefit was observed across all prespecified treatment subgroups, but its effect appears to be more pronounced in patients who have HR-negative cancer than HR-positive tumors. The magnitude of Tukysa’s PFS improvement was 44.6% and 27.5% in those two subgroups, respectively.That means Tukysa could likely play a bigger role in the HR-negative subtype of HER2-positive breast cancer in the first-line setting. Previously, in the phase 3 Patina trial, another Pfizer drug, CDK4/6 inhibitor Ibrance, showed a 26% PFS improvement when added to anti-HER2 and endocrine therapy in patients with HR-positive, HER2-positive breast cancer who responded to induction therapy.Patina’s subjects are likely different from the HR-positive subgroup of HER2CLIMB-05, Erika Hamilton, M.D., from the Sarah Cannon Research Institute and principal investigator of HER2CLIMB-05, said during a press briefing on Dec. 10. In the Tukysa trial, the median PFS for the HR-positive population in the control arm was 18 months, versus 29 months in Patina patients treated with anti-HER2 therapy plus endocrine therapy alone, she pointed out. “I think this population had a little bit more aggressive disease, a little bit less indolent disease,” Hamilton said.While the majority of patients were still alive at HER2CLIMB-05's data cutoff of Sept. 5, 2025, Tukysa also showed a promising trend toward prolonging patients’ lives, with a numerical 46.1% reduction in the risk of death. Only 7.8% of patients in the 654-subject trial have died at the time of the analysis. Investigators described the Tukysa regimen’s safety profile as “manageable,” with diarrhea, nausea and elevated liver enzymes being the most common adverse events, mostly at low grades. All told, 42.3% of patients in the Tukysa arm, versus 24.4% in the control group, experienced treatment-emergent adverse events (TEAEs) at grade 3 or above. There was one TEAE leading to death in both arms.Pfizer’s HER2CLIMB-05 regimen could further complicate the outlook for AstraZeneca and Daiichi Sankyo’s star HER2-directed antibody-drug conjugate Enhertu in its proposed first-line breast cancer indication.Recent phase 3 data from the Destiny-Breast09 trial linked the Enhertu-Perjeta combo to a 44% PFS improvement compared with current first-line standard of care. But even though Enhertu is meant to be dosed until progression, questions were raised about doctors potentially switching to the Patina regimen during maintenance for patients with HR-positive tumors, effectively shortening the treatment length—and potential the revenue—of Enhertu. Now, the Tukysa data could raise the same question for HR-negative patients.“I think the hesitation we’re hearing around [Destiny-Breast09] is really that continuing [Enhertu] indefinitely” means patients could end up taking the HER2 ADC for several years, Hamilton explained.The HER2CLIMB-05 investigator acknowledged that post-Enhertu maintenance remained a data-free zone. “But I think that even if people are using DB-09, that there’s still going to be a desire for a maintenance strategy, whether that’s Patina or HER2CLIMB-05, as I don’t think that there’s going to be an appetite to continue [Enhertu] indefinitely for patients.” As Enhertu has become a dominant second-line treatment for HER2-positive breast cancer, Tukysa is mostly used for patients with brain metastases or following progression on Enhertu. In the first nine months of 2025, Tukysa’s sales shrank to $344 million from $351 million during the same period last year.In HER2CLIMB-05, Tukysa showed similar results with the same 36% PFS improvement in both patients with and without brain metastases at baseline. Editor's note: This story was updated at 9:10 a.m. ET on Dec. 10 to include comments from Erika Hamilton, M.D., during a press conference.

Clinical ResultPhase 3ADC

100 Deals associated with Tucatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11141	Tucatinib	L01	DB11652

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	United States	Seagen, Inc.	19 Jan 2023
Metastatic breast cancer	Switzerland	Seagen, Inc.	07 May 2020
HER2 Positive Breast Cancer	United States	Seagen, Inc.	17 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 3	United States	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	China	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Japan	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Argentina	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Australia	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Austria	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Belgium	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Brazil	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Canada	Seagen, Inc.	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 3	Chile	Seagen, Inc.	24 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05132582 (HER2CLIMB-05, J Clin Oncol) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	654	Tucatinib+Trastuzumab+Pertuzumab	yqeqxjxpfm(mzwowbampt) = zpakgpdyqv dkzyvelcku (eicklvdjcr ) View more	Positive	10 Dec 2025
				Placebo+Trastuzumab+Pertuzumab	yqeqxjxpfm(mzwowbampt) = toumcrzinm dkzyvelcku (eicklvdjcr )
NCT05132582 (HER2climb-05, SABCS2025)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast Maintenance HER2+	654	Tucatinib + Trastuzumab + Pertuzumab	guxkjbdlkc(hguqxadiuj): HR = 0.539 (95.0% CI, 0.303 - 0.957), P-Value = 0.032 View more	Positive	10 Dec 2025
				Placebo + Trastuzumab + Pertuzumab
NCT05132582 (HER2CLIMB-05, Pubmed \| J Clin Oncol)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line \| Maintenance HER2+	654	Tucatinib+Trastuzumab+Pertuzumab	kibvphjzbn(inoftoyvne) = gtjzqntmzp sgcmwovuke (qltpumbqys ) View more	Positive	10 Dec 2025
				Placebo+Trastuzumab+Pertuzumab	kibvphjzbn(inoftoyvne) = lveuprtijd sgcmwovuke (qltpumbqys )
NCT05132582 (HER2CLIMB-05, BusinessWire) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	-	TUKYSA + trastuzumab + pertuzumab	pdhywdfifk(ekfexwoudu) = wzuxdzfjqq btifsvfbvt (ohvykpnssd ) Met	Positive	14 Oct 2025
				Placebo + trastuzumab + pertuzumab	-
NCT04539938 (HER2CLIMB-04, CTgov)	Phase 2	Metastatic HER2-Negative Breast Carcinoma \| HER2 Positive Breast Cancer	70	tucatinib+Trastuzumab Deruxtecan (T-DXd)	mscazbplmp = touutmzkff gkjwdpvydf (jwcudmwxyt, lwthdbsppl - fikcoomcqi) View more	-	31 Jul 2025
UNICANCER (ASCO2025)	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast Third line HR+ \| HR-	101	Tucatinib, Trastuzumab, Capecitabine (TTC)	dqonugrpis(enxicllxsz) = mxdesknnok sgxivrsuea (glqcgyrcos, 3.9 - 5.8) View more	Positive	30 May 2025
NCT04579380 (SGNTUC-019, ESMO_BC 12025 \| ESMO_BC 22025) Manual	Phase 2	HER2 Positive Breast Cancer ERBB2 Mutation (Activating)	31	Tucatinib 300 mg PO BID + Trastuzumab 8 mg/kg IV followed by 6 mg/kg Q3W	davdxxrmym(hwqjyecrnq) = cjnjijsgwv rhxosjgdhk (asqcikqkob, 26.9 - 58.2) View more	Positive	16 May 2025
ESMO_BC2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 positive	89	Tucatinib before T-Dxd	tgnsgvatff(gfaiilvbhw) = ygnfdurmgj ybvzprlwmr (njcsjudpol ) View more	-	14 May 2025
				T-Dxd before Tucatinib	tgnsgvatff(gfaiilvbhw) = dvkusvhkel ybvzprlwmr (njcsjudpol ) View more
NCT04579380 (SGNTUC-019, Pubmed \| Nat Med) Manual	Phase 2	Metastatic breast cancer HER2 Positive	31	Tucatinib + Trastuzumab	yyebsrkozu(mkuigbobbc) = gciljptweh mtjszqxckz (qodlggmavi, 26.9 - 58.2) View more	Positive	01 Mar 2025
NCT04499924 (MOUNTAINEER-02, CTgov)	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| Adenocarcinoma of Esophagus \| Locally Advanced Gastroesophageal Junction Adenocarcinoma ... View more	17	Paclitaxel (Paclitaxel 60 mg/m^2)	oxartrvpuj = idjiuqeany csumwxqshg (mfmtbqzzrs, pstgfwjuxe - kaifcwekmc) View more	-	22 Jan 2025
				Paclitaxel (Paclitaxel 80 mg/m^2)	oxartrvpuj = peinfjdehr csumwxqshg (mfmtbqzzrs, doadseyekj - qblhfalylp) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Tucatinib

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation