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
Brain Neoplasms	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
Texas	5
Pennsylvania	5
Florida	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

VERZENIO (abemaciclib): Clinical Trials Update, Market Analysis and 2026-2031 Projection

Last updated: April 26, 2026

What is Verzenio and where is it approved?

Verzenio is abemaciclib, a CDK4/6 inhibitor developed by Eli Lilly. The brand is positioned across hormone receptor-positive (HR+)/HER2-negative breast cancer and expanding metastatic niches.

Core label pillars (US/EU-style framework, by disease state)

• Early breast cancer (HR+/HER2-)
  • Adjuvant use in patients at high risk of recurrence with Ki-67 ≥20% in combination with endocrine therapy.
• Metastatic breast cancer (HR+/HER2-)
  • Monotherapy (after progression on endocrine therapy and prior chemotherapy in the metastatic setting).
  • Combination with endocrine therapy in first-line metastatic settings (depending on prior adjuvant/neo-adjuvant exposure and geography).
• Other solid tumor development
  • Abemaciclib has an R&D footprint across additional CDK4/6-sensitive cancers, but market materiality for the brand is driven by breast cancer.

What does the current clinical trial landscape look like?

Abemaciclib’s clinical program centers on three commercial engines: 1) Earlier-line settings in HR+/HER2- breast cancer 2) Expanded combination regimens with endocrine therapy and biomarker stratification (Ki-67) 3) Next-wave indications in subtypes with CDK4/6 pathway dependency

Below are the trial readouts and ongoing study structures most relevant to near-term indication expansion and line-of-therapy capture.

Breast cancer: Phase 3 outcomes shaping label depth

Adjuvant high-risk HR+/HER2- (Ki-67 driven)

• Key basis of adjuvant positioning: CDK4/6 inhibition post definitive surgery is anchored in the monarchE program (Ki-67 ≥20% high-risk cohort design). This drives clinician adoption and payor acceptance where recurrence risk stratification is used.
• Commercial impact: converts a portion of metastatic pipeline into an early-stage, chronic-treatment revenue stream.

Metastatic first-line combinations

• Key basis: Phase 3 evidence supporting abemaciclib + endocrine therapy as a first-line option in HR+/HER2- metastatic disease, with CDK4/6 class standards and physician preference shaped by progression-free survival and tolerability.
• Commercial impact: front-loads patient starts and reduces switching volatility relative to later-line monotherapy.

Metastatic later-line monotherapy

• Key basis: abemaciclib monotherapy in post-endocrine therapy settings where prior CDK4/6 exposure differs by patient history.
• Commercial impact: maintains line-of-therapy resilience and supports continuity once combination use is no longer appropriate.

Mechanistic combinations and sequencing

• Clinical programs continue testing abemaciclib in more aggressive sequencing strategies: earlier introduction, consolidation after response to endocrine therapy, and biomarker-enriched subgroups.
• The commercial objective is consistent: increase the probability that abemaciclib is selected before patients are funneled into alternative systemic regimens.

Ongoing program themes (what to watch)

Even without granular protocol-by-protocol disclosures here, the themes tied to near-term market expansion are:

• More adjuvant expansion beyond the initial Ki-67 high-risk gate (where trial results broaden eligibility).
• Earlier metastatic line capture, reducing time to first abemaciclib start.
• Biomarker refinement to strengthen payer and guideline uptake, especially in markets where reimbursement aligns to measurable risk.

How is Verzenio performing commercially by mechanism-of-demand?

Verzenio demand tracks to three buyers: 1) Adjuvant oncology spend (high-frequency, multi-year adherence) 2) First-line metastatic oncology spend (high conversion from new diagnoses) 3) Later-line spend (survival extension and sequencing advantage)

Uptake drivers

• Adjuvant adoption is the biggest structural growth driver: patients start treatment earlier and remain on therapy longer.
• Combination regimens with endocrine therapy stabilize conversion and improve physician confidence in sequencing.
• Real-world tolerability management (dose modification and supportive care pathways) reduces drop-off.

Key friction points

• CDK4/6 class intensity: patients have multiple CDK4/6 competitors, and guideline recommendations depend on country-level evidence acceptance.
• Payer criteria: adjuvant eligibility tied to measurable risk markers can delay adoption in under-resourced settings.
• Switching risk in later lines: once a patient progresses, the selection may shift toward other mechanisms if payor rules or guideline preference differ.

What is the competitive set and how does it pressure Verzenio?

In CDK4/6 HR+/HER2- breast cancer, the competitive set includes:

• Palbociclib (Ibrance)
• Ribociclib (Kisqali)
• Abemaciclib (Verzenio)

Competitive pressure points

• Efficacy parity expectations: CDK4/6s often trade off between PFS magnitude, subgroup effects, and tolerability profiles.
• Adverse event management: the market’s switching and continuation rates hinge on toxicity handling, adherence, and dose intensity.
• Dosing and scheduling: once-daily versus multi-schedule regimens affect clinic workflows and patient preference.

Market analysis: where growth should come from

A practical way to model abemaciclib growth is to separate incidence-driven adoption from share and duration effects.

Demand decomposition framework

Let:

• TAM = HR+/HER2- breast cancer population eligible for CDK4/6-based strategies
• Penetration = fraction receiving a CDK4/6 regimen
• Share = fraction selecting abemaciclib within class
• Duration = median treatment duration and continuity

Verzenio growth is most sensitive to:

• Penetration in adjuvant high-risk cohorts
• Share capture in first-line metastatic
• Duration via better tolerated dosing and earlier initiation

2026-2031 growth levers

• Adjuvant expansion: if eligibility broadens in additional high-risk subgroups, the adjuvant TAM rises.
• Line-of-therapy movement: continued evidence that abemaciclib should start earlier increases cumulative treated patient-years.
• Sequencing advantage in real-world practice: if cohorts prefer abemaciclib due to manageable adverse events, share gains persist into subsequent lines.

2026-2031 projection: base, bull, bear

Below is a structured projection for Verzenio revenues across the primary breast cancer indication set, using scenario bands (base/bull/bear) tied to adoption, share, and treatment-duration assumptions.

Scenario definitions (revenue drivers)

• Base case
  • Stable CDK4/6 class penetration
  • Incremental adjuvant and first-line metastatic share gains
  • No major label expansion beyond the current adjuvant/HR+/HER2- architecture
• Bull case
  • Additional trial readouts expand eligibility (adjuvant or earlier metastatic use)
  • Stronger than expected share retention due to tolerability and guideline embed
• Bear case
  • Competitive share erosion in later lines
  • Payer restrictions slow treatment starts in borderline-risk adjuvant cohorts

Projection table (global brand revenues)

Revenue in USD billions.

Year	Bear	Base	Bull
2026	8.0	10.2	12.5
2027	8.4	10.9	13.6
2028	8.8	11.6	14.7
2029	9.3	12.4	15.8
2030	9.7	13.2	17.0
2031	10.2	14.1	18.3

What moves the needle

• Bear-to-base spread reflects share and duration compression.
• Base-to-bull spread reflects label expansion or faster-than-expected adoption in earlier treatment settings.

Investment and R&D implications

R&D posture

• The commercial path for Verzenio is not binary. It is additive across:
  • Adjuvant eligibility expansion
  • Earlier metastatic sequencing
  • Biomarker-enriched uptake
• The highest ROI comes from trials that reduce clinical ambiguity for patient selection and strengthen guideline consensus.

Commercial posture

• Strategy should prioritize:
  • Adjuvant physician education around risk stratification and Ki-67 workflows
  • Payer dossier clarity (evidence-to-eligibility mapping)
  • Adherence programs to preserve dose intensity and duration

Key Takeaways

• Verzenio revenue growth through 2031 should be driven primarily by adjuvant high-risk HR+/HER2- adoption and earlier-line metastatic capture, with additional upside tied to trial readouts that broaden eligible cohorts.
• The competitive market is structurally stable across CDK4/6 class, so share and duration are the main levers, not class-wide penetration shocks.
• Scenario modeling implies a meaningful range: USD 10.2B to 18.3B by 2031, with the base case at USD 14.1B under continued adjuvant traction and modest share expansion.

---

FAQs

1) What is the primary commercial indication driving Verzenio?

HR+/HER2- breast cancer across metastatic and adjuvant disease states, with adjuvant high-risk cohorts acting as the largest structural duration driver.

2) What clinical trial themes matter most for market expansion?

Studies that expand eligible populations in earlier disease settings and strengthen biomarker-defined adoption (especially Ki-67-driven strategies) have the biggest commercial impact.

3) How does tolerability influence revenue?

Tolerability and dose-modification pathways affect persistence, continuation rates, and switching timing, which determine both duration and class-share retention.

4) What is the main competitive risk for Verzenio?

Class competition from palbociclib and ribociclib can shift prescribing and payer preference, especially when later-line sequencing becomes less stable.

5) What timeframe captures the largest growth inflection for Verzenio?

The 2026-2028 window should reflect the compounding of adjuvant uptake plus incremental first-line metastatic share gains, with additional lift from any label expansion.

---

References

[1] Eli Lilly. Verzenio (abemaciclib) prescribing information.
[2] ClinicalTrials.gov. Abemaciclib interventional studies in HR+/HER2- breast cancer (various trial records, monarchE and related CDK4/6 program entries).
[3] FDA. Verzenio (abemaciclib) approvals and labeling history.
[4] EMA. Verzenio (abemaciclib) EPAR and indication updates.