CLINICAL TRIALS PROFILE FOR KADCYLA

Biosimilar Clinical Trials for KADCYLA

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.

All Clinical Trials for KADCYLA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01419197 ↗	A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy	Completed	Hoffmann-La Roche	Phase 3	2011-09-01	This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
NCT01702558 ↗	A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)	Terminated	Hoffmann-La Roche	Phase 2	2012-12-03	This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.
NCT01904903 ↗	Cardiac Safety Study in Patients With HER2 + Breast Cancer	Completed	Genentech, Inc.	Phase 2	2013-10-01	HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer. Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function. In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months. We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.
NCT01904903 ↗	Cardiac Safety Study in Patients With HER2 + Breast Cancer	Completed	Medstar Health Research Institute	Phase 2	2013-10-01	HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer. Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function. In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months. We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.
NCT01904903 ↗	Cardiac Safety Study in Patients With HER2 + Breast Cancer	Completed	Washington Hospital Center	Phase 2	2013-10-01	HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer. Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function. In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months. We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.

Clinical Trial Conditions for KADCYLA

Condition Name

Condition Name for KADCYLA
Intervention	Trials
Breast Cancer	17
HER2-positive Breast Cancer	8
Metastatic Breast Cancer	7
Refractory Malignant Solid Neoplasm	3

Condition MeSH

Condition MeSH for KADCYLA
Intervention	Trials
Breast Neoplasms	34
Carcinoma	6
Neoplasms	6
Stomach Neoplasms	3

Clinical Trial Locations for KADCYLA

Trials by Country

Trials by Country for KADCYLA
Location	Trials
United States	293
Italy	35
Canada	27
Brazil	19
Spain	18

Trials by US State

Trials by US State for KADCYLA
Location	Trials
Texas	13
Massachusetts	12
Tennessee	11
Oregon	11
Missouri	10

Clinical Trial Progress for KADCYLA

Clinical Trial Phase

Clinical Trial Phase for KADCYLA
Clinical Trial Phase	Trials
Phase 3	7
Phase 2/Phase 3	1
Phase 2	21

Clinical Trial Status

Clinical Trial Status for KADCYLA
Clinical Trial Phase	Trials
Recruiting	11
Completed	9
Active, not recruiting	9

Clinical Trial Sponsors for KADCYLA

Sponsor Name

Sponsor Name for KADCYLA
Sponsor	Trials
Hoffmann-La Roche	11
Genentech, Inc.	8
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for KADCYLA
Sponsor	Trials
Other	38
Industry	36
NIH	7

Last updated: July 28, 2026

KADCYLA clinical trials update, market analysis, and 2025–2035 revenue projections (trastuzumab emtansine)

Executive summary: KADCYLA (trastuzumab emtansine, T-DM1) is in late-line HER2-positive breast cancer use and faces patent-driven competitive entry risk mainly from trastuzumab deruxtecan and other HER2 ADCs rather than immediate direct generic pressure. Near-term growth is constrained by sequencing preferences and label competition, while long-term demand is most exposed to uptake shifts toward next-generation ADCs and regimens, plus incremental share gains in residual treatment settings (including post-THP and post-T-DXd migration depending on evolving guidelines).

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What is the latest clinical trial status for KADCYLA (trastuzumab emtansine) in HER2+ breast cancer?

Current positioning: KADCYLA is used for HER2-positive metastatic breast cancer after prior trastuzumab and taxane, and for certain early-stage residual disease settings when pathologic complete response is not achieved following neoadjuvant therapy (per its existing label). Clinical development continues to explore:

• Earlier lines and expanded populations (including combinations)
• Substitution strategies versus newer ADCs and anti-HER2 regimens
• Biomarker stratification to improve response and duration

Featured decision drivers in ongoing programs

• Comparator selection: Trials increasingly benchmark against T-DXd (trastuzumab deruxtecan) or T-DXd-inclusive strategies rather than trastuzumab/pertuzumab alone.
• Safety management: Thrombocytopenia, hepatotoxicity, neuropathy, and ocular events remain the core tolerability constraints shaping dose intensity and discontinuation rates.
• Sequencing: Outcomes depend on whether patients have prior T-DXd exposure or other ADC exposure, which can change response dynamics and safety profiles.

Which KADCYLA combination trials are most likely to change label or sequencing?

• Trials combining T-DM1 with chemotherapy backbone regimens or with targeted agents aimed at improving progression-free survival without unacceptable overlapping toxicity.
• Studies designed to evaluate whether KADCYLA retains benefit in subgroups with limited prior anti-HER2 options.

Is KADCYLA being tested in early-stage HER2+ breast cancer updates?

• Ongoing efforts generally focus on extending benefit beyond standard adjuvant-adjacent use and clarifying the role versus other adjuvant HER2 ADCs or dual-antibody strategies.
• Trial endpoints emphasize event-free survival and invasive disease-free survival with safety and treatment-completion rates as secondary decision gates.

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What do recent market and guideline shifts imply for KADCYLA demand vs T-DXd and other HER2 ADCs?

Market reality: HER2 ADC adoption is moving fast. T-DXd (Enhertu) and other ADCs have changed the competitive set for HER2-positive metastatic breast cancer, especially for patients who previously received trastuzumab-based therapy and chemotherapy.

Key implication for KADCYLA commercial outlook

• Share pressure: Even where KADCYLA retains guideline-listed roles, competitive ADCs can shift treatment patterns toward newer options with higher response rates or longer PFS in specific datasets.
• Line-of-therapy compression: If newer agents move earlier in sequencing, KADCYLA can become a “later-line” default, limiting addressable volume.
• Treatment duration: ADC switches and discontinuation patterns impact the number of treatment cycles and therefore revenue per patient.

Which competitors matter most to KADCYLA revenue projection?

• Trastuzumab deruxtecan (T-DXd, Enhertu): primary substitution risk in HER2 metastatic settings.
• Other HER2 ADCs: include agents targeting HER2 with different payloads/linkers, which can siphon patients if efficacy and tolerability profiles outperform in specific subgroups.
• Standard-of-care anti-HER2 regimens: trastuzumab plus pertuzumab-based combinations and taxane backbones remain relevant where ADC access is limited or where patient comorbidity constrains ADC selection.

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What is the KADCYLA revenue trajectory and what drives global uptake?

Revenue drivers

1. Eligible population size in HER2-positive breast cancer across early-stage residual disease and metastatic lines
2. Treatment adherence (dose intensity and discontinuation rates from safety)
3. Sequencing and switching behavior after prior therapies
4. Geographic reimbursement dynamics that affect ADC adoption speed
5. Competitive access through payer formularies and hospital contracting

Market sizing approach used for projections

Revenue is projected from:

• Addressable patient counts by geography and line (early-stage and metastatic)
• Expected fraction receiving T-DM1 per year based on guideline fit and payer/prescriber behavior
• Average treatment duration (cycles) adjusted for discontinuation and dose modifications
• Net price assumptions reflecting typical ADC discounts, country rebates, and tendering where applicable

(A full quantitative forecast requires a specific dataset such as IQVIA/GlobalData/Sponsor financials and local net price books; this response is limited to directional projection logic consistent with patent and competitive dynamics.)

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When does KADCYLA lose exclusivity, and what patents control generic or biosimilar entry risk?

Primary exclusivity risk: KADCYLA is a small-molecule-free biologic-like ADC containing trastuzumab with a cytotoxic payload. Generic small-molecule entry is not expected. Competitive entry is more likely via:

• Biosimilar trastuzumab-based analogs without the emtansine payload (not a direct substitute for KADCYLA efficacy)
• Next-generation HER2 ADCs using different linkers/payloads that can be clinically substituted
• Patent challenges targeting method, composition, payload/linker, and manufacturing process claims

How to think about exclusivity timelines for ADCs

For ADCs, the practical “exclusivity clock” is governed by:

• Patent expiry on the ADC composition and specific embodiments (including linker-payload chemistry)
• Process patents for conjugation steps, DAR distribution control, and purification
• Method-of-use patents tied to HER2+ breast cancer settings and sequences

Business impact: Even as basic trastuzumab antibody patents expire, T-DM1’s commercial defensibility depends on ADC-specific claims.

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What patent litigation and regulatory events affect KADCYLA’s competitive threat?

Litigation and administrative risk profile

• ADCs typically see patent-driven disputes around composition claims and process claims rather than “AbbVie-style” simple formulation generic equivalents.
• The most relevant commercial threats tend to come from competitor ADC trial results and regulatory label updates, which can reduce the addressable T-DM1 share quickly.

What “generic entry” risks exist for KADCYLA?

• “Direct generic” is not the relevant frame.
• The practical threat is clinical and legal substitutability: a new ADC can replicate or exceed endpoints, shifting prescribing away from T-DM1.

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What is the FDA regulatory status of KADCYLA, and what trial outcomes could expand the label?

Regulatory context

• KADCYLA already has approvals in specified HER2-positive breast cancer settings.
• Future label expansion would most likely follow trials that show improved PFS/OS over the current standard comparator in the targeted population, with safety manageable in real-world settings.

Which FDA endpoint packages typically support HER2 ADC label expansion?

• Co-primary endpoints such as PFS with OS maturity, or event-free survival in early-stage
• Safety data showing acceptable discontinuation and grade 3/4 adverse event incidence
• Consistency across biomarker-enriched subgroups (HER2 IHC/FISH status, hormone receptor status where relevant)

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What formulations and manufacturing/IP barriers protect KADCYLA?

ADC manufacturability

• ADCs depend on controlled conjugation chemistry, payload distribution, and stability.
• Manufacturing IP commonly includes:
  • Linker-payload synthesis
  • Conjugation conditions
  • Purification and characterization parameters
  • DAR distribution control
  • Analytical release criteria

Why these barriers matter commercially

• Even if a competitor can develop a similar payload-linker approach, matching critical quality attributes and achieving comparable stability and efficacy at scale is expensive and time-consuming.
• This increases launch friction and reduces the probability of rapid price erosion.

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How does KADCYLA compare with T-DXd and other HER2 ADCs on efficacy and safety trade-offs?

Competitive comparison framework

• Response rate, duration of response, and PFS in metastatic HER2-positive populations
• Safety trade-offs: thrombocytopenia and hepatotoxicity patterns for T-DM1 vs interstitial lung disease risk profile and GI toxicity considerations for T-DXd, plus neuropathy differences and infusion reactions
• Patient selection effects and prior-treatment effects

What prescribing behavior typically follows ADC-to-ADC comparisons?

• If the newer ADC shows clearer efficacy in the same line and has manageable toxicity, KADCYLA can be displaced even if still effective.
• Payer coverage can accelerate displacement when outcomes are supported by stronger comparative evidence.

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Key 2025–2035 market projection for KADCYLA: base, downside, and upside scenarios

Directional forecast only (no proprietary dataset provided):

Base case (status quo competition, incremental share erosion)

• KADCYLA revenue grows modestly or remains flat globally as early-stage residual disease demand offsets metastatic share erosion.
• Growth is constrained by line-of-therapy shifts toward newer ADCs.

Downside case (accelerated substitution by next-gen ADCs)

• Faster guideline adoption and payer formulary changes move KADCYLA deeper into later lines.
• Net patient throughput declines, treatment duration shortens with earlier switching, and revenue trends soften.

Upside case (label expansion and favorable sequencing evidence)

• Positive trial readouts position KADCYLA in a broader population or earlier setting with acceptable safety.
• If comparative data supports superior patient outcomes in a defined subgroup, share could stabilize and expand.

What outcomes most influence which scenario occurs?

• Comparative trial results vs T-DXd in matched populations
• Data on safety tolerability management allowing sustained dose intensity
• Evidence of durable benefit in prior-ADC exposure settings

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KADCYLA strategic implications: where to defend and where to reposition

Defend

• Retain share where the label fits tightly and where clinicians perceive consistent benefit with predictable toxicity monitoring.
• Build payer-friendly evidence packages focused on treatment completion and real-world dosing.

Reposition

• Prioritize biomarker-defined niches where response duration is strongest.
• Use sequencing evidence to argue against early replacement by newer ADCs in patient subgroups.

Licensing and BD

• The more immediate business opportunities are likely in combination trials and regimen sequencing rather than “generic-like” substitution partnerships.

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Key Takeaways

• KADCYLA faces a commercial threat primarily from competing HER2 ADCs, especially trastuzumab deruxtecan, driven by sequencing and payer formulary dynamics.
• The exclusivity defense for KADCYLA is tied to ADC-specific composition and manufacturing/process IP, making direct generic pressure unlikely in the near term.
• 2025–2035 revenue outcomes are most sensitive to how quickly next-gen ADCs expand earlier in therapy lines and how real-world treatment duration changes with ADC switching.

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FAQs

1. What is the dominant reason KADCYLA is displaced in HER2 metastatic sequencing?
2. How do thrombocytopenia and hepatotoxicity drive dose modifications and net treatment cycles for KADCYLA?
3. Can KADCYLA remain competitive after prior exposure to other HER2 ADCs?
4. Which trial endpoints are most decisive for expanding KADCYLA into earlier lines?
5. What patent categories most constrain competitor ADC development around trastuzumab emtansine?

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References

1. FDA Drug Label: KADCYLA (trastuzumab emtansine). U.S. Food and Drug Administration.
2. European Medicines Agency (EMA). KADCYLA assessment history and EPAR documentation (trastuzumab emtansine).
3. ClinicalTrials.gov. KADCYLA (trastuzumab emtansine) study records and statuses.