CLINICAL TRIALS PROFILE FOR TALZENNA

All Clinical Trials for TALZENNA

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 TALZENNA

Condition Name

Condition Name for TALZENNA
Intervention	Trials
Breast Cancer	6
Triple Negative Breast Cancer	4
Advanced Malignant Solid Neoplasm	2
Solid Tumor	2

Condition MeSH

Condition MeSH for TALZENNA
Intervention	Trials
Breast Neoplasms	7
Triple Negative Breast Neoplasms	5
Neoplasms	3
Leukemia	3

Clinical Trial Locations for TALZENNA

Trials by Country

Trials by Country for TALZENNA
Location	Trials
United States	109
Canada	2
Poland	1
Malaysia	1
Belgium	1

Trials by US State

Trials by US State for TALZENNA
Location	Trials
Texas	8
New York	6
Massachusetts	6
California	5
Georgia	5

Clinical Trial Progress for TALZENNA

Clinical Trial Phase

Clinical Trial Phase for TALZENNA
Clinical Trial Phase	Trials
Phase 2	9
Phase 1/Phase 2	8
Phase 1	6

Clinical Trial Status

Clinical Trial Status for TALZENNA
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	2
Terminated	2

Clinical Trial Sponsors for TALZENNA

Sponsor Name

Sponsor Name for TALZENNA
Sponsor	Trials
Pfizer	16
Genentech, Inc.	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for TALZENNA
Sponsor	Trials
Industry	40
Other	27
NIH	3

Clinical Trials, Market Analysis, and Future Projections for Talzenna (Talazoparib)

Last updated: February 24, 2026

What is the current status of clinical trials for Talzenna?

Talzenna (talazoparib) is an oral PARP (poly ADP-ribose polymerase) inhibitor approved for treating specific cancers. As of early 2023, it has completed multiple pivotal trials, notably:

• OlympiAD trial: Phase 3, demonstrating efficacy in advanced HER2-negative breast cancer with germline BRCA mutations.
• EMBRACA trial: Phase 3, showing benefits in metastatic breast cancer with BRCA mutations.

Additional trials focus on expanding indications:

• Adjuvant breast cancer: Ongoing Phase 3 trial assessing Talzenna in early-stage disease.
• Prostate cancer: Trials in combination with other agents for metastatic castration-resistant prostate cancer (mCRPC).
• Ovarian cancer: Phase 2 studies explore efficacy inBRCA-mutated ovarian cancer.

What is the market landscape for Talzenna?

Market Size and Segmentation

The global PARP inhibitor market, valued at nearly USD 4.2 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 11% through 2030. Major market segments include:

• Breast cancer: Constitutes approximately 55% of PARP inhibitor sales; HER2-negative, BRCA-mutated subtypes dominate.
• Ovarian cancer: Accounts for 30%, especially in maintenance and recurrent settings.
• Prostate cancer: Growing segment, driven by an increase in diagnoses and pipeline progress.

Competitive Landscape

Main competitors include:

• Lynparza (olaparib): Pfizer
• Zejula (niraparib): GSK
• Rubraca (rucaparib): Clovis Oncology

Talzenna faces competition in indications with established therapies, but its unique approval for early breast cancer gives it a distinct niche.

Revenue and Sales Data

In 2022, primary sales were driven by use in metastatic breast cancer, with reported revenues of approximately USD 180 million. The drug's market share in this segment is estimated at 20%, with growth expected as label expansions occur.

What are future projections for Talzenna?

Market Forecast

By 2030, the global PARP inhibitor market reach USD 10.5 billion, with Talzenna expected to maintain a significant share due to:

• [1] Expansion into earlier lines of therapy.
• [2] Approval for additional cancer types, notably prostate and ovarian.
• [3] Increased adoption for adjuvant and maintenance therapy.

Key Factors Influencing Growth

• Status of ongoing clinical trials supporting broader indications.
• Regulatory approvals in emerging markets such as China and the European Union.
• Competitive dynamics with established drugs like Lynparza.
• Pricing strategies and reimbursement policies.

Adoption Drivers

• Growing biomarker-driven treatment approaches favoring BRCA mutation status.
• Combination therapies with immunotherapy and other targeted agents.
• Physician and patient acceptance of oral therapies with manageable side effect profiles.

Key Takeaways

• Talzenna has demonstrated efficacy in metastatic BRCA-mutated breast cancer, with ongoing trials assessing broader indications.
• The PARP inhibitor market is driven by breast, ovarian, and prostate cancers, with projected growth at a CAGR of 11%.
• Competitive pressures from Lynparza and others persist, but new approvals and label expansions may secure Talzenna's market position.
• Revenue is expected to increase with label expansions and geographic expansion, particularly into Asia and Europe.
• Pipeline developments will shape the drug’s long-term market share and valuation.

FAQs

1. What specific cancers is Talzenna approved for?
Primarily for BRCA-mutated advanced or metastatic HER2-negative breast cancer, with potential future approvals in prostate and ovarian cancers.

2. How does Talzenna compare to competitors?
It offers oral administration and has a proven record in early breast cancer, which might give it an edge in certain niches compared to intravenous PARP inhibitors.

3. Are there significant side effects to consider?
Common adverse effects include anemia, nausea, fatigue, and neutropenia. Long-term safety profiles are being monitored in ongoing trials.

4. When might broader indications be approved?
Expect initial results from ongoing Phase 3 trials in early breast and prostate cancers by 2025, with possible label updates by 2026–2027.

5. What are the key challenges for Talzenna's market growth?
Intense competition, reimbursement hurdles, and the need for additional clinical data to expand indications.

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References

[1] MarketsandMarkets. (2023). Poly ADP-ribose polymerase (PARP) inhibitors market.
[2] IQVIA. (2023). Oncology drug sales data.
[3] U.S. Food and Drug Administration. (2018). Talzenna approval documentation.
[4] Global Data. (2023). PARP inhibitors pipeline analysis.
[5] Fierce Pharma. (2023). PARP inhibitor market overview.