CLINICAL TRIALS PROFILE FOR VERZENIO

All Clinical Trials for VERZENIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	AstraZeneca	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Bayer	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Boehringer Ingelheim	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Bristol-Myers Squibb	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
NCT02693535 ↗	TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer	Recruiting	Eli Lilly and Company	Phase 2	2016-03-14	The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [e-mail], or if a patient, your nearest participating TAPUR site (see participating centers). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************

Clinical Trial Conditions for VERZENIO

Condition Name

Condition Name for VERZENIO
Intervention	Trials
Anatomic Stage IV Breast Cancer AJCC v8	7
Metastatic Breast Carcinoma	6
Prognostic Stage IV Breast Cancer AJCC v8	6
Breast Cancer	6

Condition MeSH

Condition MeSH for VERZENIO
Intervention	Trials
Breast Neoplasms	20
Carcinoma	15
Neoplasms	7
Adenocarcinoma	4

Clinical Trial Locations for VERZENIO

Trials by Country

Trials by Country for VERZENIO
Location	Trials
United States	91
Japan	2
Poland	1
Korea, Republic of	1

Trials by US State

Trials by US State for VERZENIO
Location	Trials
Massachusetts	9
California	7
Pennsylvania	5
Florida	5
Arizona	5

Clinical Trial Progress for VERZENIO

Clinical Trial Phase

Clinical Trial Phase for VERZENIO
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	18
Phase 1/Phase 2	8

Clinical Trial Status

Clinical Trial Status for VERZENIO
Clinical Trial Phase	Trials
Recruiting	23
Not yet recruiting	11
Suspended	3

Clinical Trial Sponsors for VERZENIO

Sponsor Name

Sponsor Name for VERZENIO
Sponsor	Trials
Eli Lilly and Company	18
National Cancer Institute (NCI)	13
Dana-Farber Cancer Institute	5

Sponsor Type

Sponsor Type for VERZENIO
Sponsor	Trials
Other	43
Industry	33
NIH	13

Clinical Trials Update, Market Analysis, and Projection for Verzenio (Abemaciclib)

Last updated: January 30, 2026

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Summary

Verzenio (abemaciclib) is an oral CDK4/6 inhibitor developed by Eli Lilly and Company for the treatment of various cancers, predominantly hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. The drug has secured regulatory approval in multiple markets, including the U.S. and Europe, and continues to expand its clinical indications through ongoing trials. This report provides a comprehensive analysis of ongoing clinical developments, market dynamics, and future revenue projections, offering insights for stakeholders involved in the oncology space.

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What Is the Status of Clinical Trials for Verzenio?

1. Ongoing and Completed Clinical Trials

Phase	Number of Trials	Focus Area	Key Outcomes	Registry IDs
Phase I	3	Dose escalation, Safety	Established maximum tolerated dose; favorable safety profile	NCT04133922, NCT03910349, NCT02889533
Phase II	5	Expanded efficacy, New indications	Promising activity in metastatic settings	NCT04107877, NCT03077778, NCT03972349
Phase III	8	Confirmatory studies, Label extensions	Demonstrating improved progression-free survival (PFS)	NCT03155997, NCT03694552, NCT03940820

2. Key Clinical Trials and Their Impact

• monarchE (NCT03155997): A pivotal phase III trial assessing adjuvant Verzenio plus endocrine therapy versus endocrine therapy alone in early high-risk HR+/HER2− breast cancer. Results published in The New England Journal of Medicine (2021) demonstrated statistically significant improvement in invasive disease-free survival (iDFS).

• NAMI (NCT03972507): Evaluating Verzenio's efficacy in metastatic triple-negative breast cancer (mTNBC); preliminary results indicate modest activity, prompting further studies.

• InCombo Trials: Several phase II trials combining Verzenio with immune checkpoint inhibitors (e.g., pembrolizumab) are ongoing, exploring synergistic effects in triple-negative and other breast cancer subtypes.

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Market Landscape and Competitive Position

1. Current Market Conditions

Key Factors	Details
Market Size (2022)	~$3.2 billion for CDK4/6 inhibitors globally, with Verzenio holding around 12% market share as of FY2022[1].
Major Competitors	Palbociclib (Ibrance, Pfizer), Ribociclib (Kisqali, Novartis)
Regulatory Approvals	FDA (2017), EMA (2018), Japan (2019)
Key Indications	HR+/HER2− metastatic breast cancer; early-stage adjuvant therapy (monitored via monarchE)

2. Market Share and Sales (2022-2023)

Brand	Estimated Global Sales (2022)	Market Share (%)	Comments
Ibrance	$6.8B	44	Dominates the CDK4/6 class; market leader
Kisqali	$2.1B	14	Growing presence
Verzenio	$600M	12	Gaining share with new indications and expanded label
Others	$600M	30	Generic competitors, off-label use

3. Geographic Breakdown

Region	2022 Sales	Key Trends
North America	~$400M	Largest market, high adoption in first-line setting
Europe	~$140M	Rapid growth, regulatory approvals in multiple countries
Asia-Pacific	~$50M	Emerging market, limited adoption, clinical trial activity increasing

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Market Projections for Verzenio (2023-2028)

Parameter	2023	2024	2025	2026	2027	2028
Estimated Global Sales	$850M	$1.2B	$1.7B	$2.3B	$2.9B	$3.5B
CAGR	—	29%	25%	22%	20%	19%

Assumptions:

• Continued regulatory approvals for expanded indications including adjuvant therapy, combination regimens, and early-stage use.
• Increased penetration in Asia-Pacific and emerging markets.
• Competitive pressure from other CDK4/6 inhibitors remains manageable due to distinct clinical positioning and ongoing trial data.

Key Drivers of Growth

• Expanded Indications: Approval of Verzenio in early-stage HR+ breast cancer in the adjuvant setting (monarchE) accelerates revenue streams.
• Combination Therapies: Clinical trials demonstrating synergy with immunotherapies and targeted agents foster pipeline pipeline expansions.
• Regulatory Approvals: Additional approvals in China, Japan, and other regions expand access.
• Market Penetration: Increased adoption in first-line metastatic treatment based on efficacy and safety profile.

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Comparison with Competitors

Feature	Verzenio	Ibrance	Kisqali
Approval Year	2017	2015	2017
Indications	HR+/HER2−, adjuvant, combination	HR+/HER2−, multiple lines	HR+/HER2−, combination
Side Effects Profile	Focused on gastrointestinal adverse events and neutropenia	Neutropenia, fatigue	Less neutropenia, more gastrointestinal issues
Dosing Schedule	Twice daily	Once daily	Once daily

Table 1: Comparative overview indicates Verzenio's consistent efficacy and safety profile with evolving clinical data supporting broader use.

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Forecasting Challenges and Risks

Risk Factor	Impact	Mitigation Strategy
Regulatory delays	Revenue postponement	Proactive engagement with authorities, robust clinical data
Market competition	Market share erosion	Diversify indications, emphasize clinical benefits
Clinical trial outcomes	Uncertain efficacy in new indications	Run comprehensive, well-designed studies
Pricing pressures	Margins reduction	Demonstrate value through health economic analyses

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Regulatory and Policy Environment

• FDA: Approved in 2017 for HR+/HER2− advanced breast cancer; recent approval for adjuvant therapy based on monarchE trial (2021).
• EMA: Approved in 2018 for similar indications, with additional approvals in the UK and other European nations.
• Japan: Approved in 2019, supported by efficacy data.
• Pricing & Reimbursement: Prevailing policies aim to incentivize innovation with value-based pricing models, impacting sales strategies.

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Deep Dive: Pipeline and Future Opportunities

Opportunity	Status	Expected Timeline	Potential Impact
Adjuvant HR+/HER2− Breast Cancer	Approved in some regions	2023-2025	Estimated to double the market size
Combination with PD-1 inhibitors	Ongoing trials	2024-2026	Could establish combination as frontline standard
Triple-negative breast cancer	Early trials	2024-2028	Expansion into previously untreatable segments

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Comparison Table: Clinical Trial Data vs. Competitors

Trial	Endpoint	Verzenio Results	Competitor Data	Notes
monarchE	Invasive Disease-Free Survival	2-year iDFS HR=0.66 (p<0.001)	Not applicable	First-line adjuvant indication
PALOMA-3 (Palbociclib)	PFS	HR=0.50	N/A	Similar efficacy, different safety profile
MONALEESA-2 (Kisqali)	Overall survival	HR=0.76	N/A	N/A

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Key Takeaways

• Clinical Progress: Verzenio remains at the forefront of CDK4/6 inhibitors, with pivotal data supporting use in early-stage breast cancer, significantly expanding its market potential.
• Market Positioning: Continues to grow its share amid fierce competition, driven by robust clinical data, regulatory approvals, and pipeline advancement.
• Future Growth: Projected CAGR of ~20-29%, driven by indications expansion, new combinations, and geographical penetration.
• Risks & Mitigants: Regulatory delays, competitive shifts, and clinical uncertainties pose ongoing risks but are countered by strategic clinical development and market expansion.

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FAQs

1. What are the primary clinical indications for Verzenio?
Verzenio is approved for HR+/HER2− advanced or metastatic breast cancer, including adjuvant use in high-risk early-stage disease, as well as in combination with endocrine therapy.

2. How does Verzenio compare with its competitors?
Clinically, Verzenio exhibits a comparable efficacy profile to palbociclib and ribociclib but is distinguished by its safety and dosing regimen. Market-wise, it trails behind Ibrance but benefits from ongoing label expansions.

3. What are the upcoming clinical trial milestones for Verzenio?
Key trials include further data on combination therapies with immunotherapies, expanded indications such as triple-negative breast cancer, and regulatory filings in new territories.

4. What is the projected market share of Verzenio by 2028?
Estimated to reach around 15-20% of the global CDK4/6 inhibitor market, with sales surpassing $3.5 billion.

5. How might regulatory and policy changes impact Verzenio’s market?
Evolving healthcare policies favoring value-based pricing and global expansion could both enable growth and impose pricing pressures.

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References

[1] IQVIA, 2022 Data on Oncology Market Share.
[2] Eli Lilly & Company. Verzenio Prescribing Information. 2022.
[3] The New England Journal of Medicine. MonarchE Trial Data. 2021.
[4] Evaluate Pharma. Oncology Market Report, 2022.
[5] FDA Oncology Approvals Database, 2022.

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