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. ********************************************************************************************* *********************************************************************************
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	Genentech, Inc.	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
Solid Tumor	2
Recurrent Malignant Solid Neoplasm	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
Spain	1
Denmark	1
Poland	1

Trials by US State

Trials by US State for TALZENNA
Location	Trials
Texas	8
New York	6
Massachusetts	6
Georgia	5
California	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
Terminated	2
Not yet recruiting	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

Talzenna: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Talzenna (alpelisib) is an oral phosphatidylinositol 3-kinase (PI3K) inhibitor developed by Novartis for targeted cancer therapy. Primarily approved for use in PIK3CA-mutated advanced or metastatic breast cancer, Talzenna represents a strategic advancement in precision oncology. This article provides a comprehensive update on Talzenna's clinical trial landscape, analyzes its current market positioning, and projects future growth prospects based on ongoing developments.

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Clinical Trials Landscape for Talzenna

Current Clinical Development Status

As of 2023, Talzenna maintains an active clinical trial portfolio focusing on its efficacy, safety, and combination therapies across various cancer types. The drug is primarily evaluated in triple-negative breast cancer (TNBC), hormone receptor-positive (HR+), PIK3CA-mutant breast cancer, and other solid tumors.

• Phase III Trials:
  The SOLAR-1 trial is pivotal, demonstrating significant progression-free survival (PFS) benefits when Talzenna combined with fulvestrant in HR+, PIK3CA-mutant advanced breast cancer. The trial's results contributed to FDA approval in 2020, establishing Talzenna as a precision medicine option.

• Ongoing Investigations:
  Multiple Phase II and III studies explore Talzenna in combination with other agents:

  • BYLieve Study (NCT02973737): Assesses Talzenna plus fulvestrant beyond prior CDK4/6 inhibitor therapy.
  • NCT05100309: Exploring Talzenna in combination with PD-1 inhibitors in PD-L1-positive TNBC.
  • NCT04656446: Evaluating Talzenna with standard chemotherapy in other solid tumors.

• Additional Trials:
  Novartis continues expanding indications, including early-stage cancers, resistance settings, and combination regimens, indicating a strategic push to broaden Talzenna’s therapeutic reach.

Regulatory Milestones & Approvals

• United States:
  FDA approved Talzenna (alpelisib) in combination with fulvestrant for HR+, PIK3CA-mutated, advanced or metastatic breast cancer following endocrine therapy.
• Europe & Japan:
  Regulatory evaluations are ongoing, with filings under review to secure broader access.

Safety and Efficacy Data

Clinical trials consistently demonstrate the efficacy of Talzenna in selected patient populations. Notably, in SOLAR-1:

• Median PFS extended to 11 months versus 5.7 months with standard care.
• Common adverse events include hyperglycemia, rash, and diarrhea; manageable with appropriate supportive care.

Emerging data suggests that combining Talzenna with other targeted agents may improve outcomes but raises concerns regarding toxicity profiles necessitating rigorous safety monitoring.

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Market Analysis

Current Market Position

The global oncology drug market is highly competitive, with targeted therapies gaining predominant market share. Talzenna's initial success is driven by:

• Specificity for PIK3CA mutations: This molecular precision ensures better response rates.
• Regulatory backing: FDA approval has accelerated clinician adoption.
• Companion diagnostic availability: The PIK3CA mutation test (e.g., therascreen PIK3CA RGQ PCR Kit) enhances patient selection accuracy, enabling optimal therapy.

As per IQVIA data, the breast cancer targeted therapy segment is expanding rapidly, with special emphasis on PIK3CA inhibitors, in which Talzenna is a leading agent.

Competitive Landscape

Talzenna’s main competitors include:

• Pictilisib (GDC-0941): A PI3K inhibitor with limited clinical success.
• Alpelisib (BYL719): The same molecule marketed by Novartis in other regions, affirming Novartis' dominance.
• Emerging Agents: Buparlisib and taselisib face challenges due to toxicity, though ongoing trials aim to optimize therapeutic windows.

The market is also impacted by the advent of combination regimens involving CDK4/6 inhibitors, immunotherapies, and other targeted agents.

Market Dynamics & Revenue Projections

The global breast cancer therapeutics market was valued at over $20 billion in 2022, with targeted therapies constituting approximately 40%. Given the increasing prevalence of PIK3CA mutations and the emphasis on personalized medicine, sales of Talzenna are expected to grow.

• 2023–2025:
  Projected compounded annual growth rate (CAGR) of around 12-15%, driven by expanding indications, ongoing clinical trials, and increased diagnostic testing.

• Long-term Outlook (2025–2030):
  As efficacy data from combination strategies emerge and additional indications are approved, sales could surpass $2 billion globally, positioning Talzenna as a cornerstone of targeted breast cancer therapy.

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Future Projections and Strategic Opportunities

Pipeline Expansion

Novartis aims to demonstrate Talzenna's efficacy across earlier lines of therapy and in other tumor types such as:

• Gastrointestinal cancers: Ongoing trials in PIK3CA-mutant colorectal and gastric cancers.
• Lung cancers: Exploring co-targeting pathways for enhanced efficacy.
• Resistance mechanisms: Focusing on overcoming resistance to endocrine and HER2-targeted therapies.

Biomarker Development & Companion Diagnostics

Further refinement of molecular diagnostics will enhance patient stratification, maximizing therapeutic benefit and minimizing adverse effects. Investment in next-generation sequencing (NGS) technologies could expand access.

Combination Therapy Strategies

Synergy with immunotherapies (checkpoint inhibitors) and novel targeted agents provides avenues for combination regimens, potentially leading to superior outcomes and market differentiation.

Regulatory and Market Access Outlook

Pending approvals across Europe, Asia, and Latin America will diversify revenue streams. Strategic partnerships with diagnostic companies will facilitate broader testing and patient access.

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Key Takeaways

• Talzenna holds a strategic position in the targeted breast cancer therapy market, backed by robust clinical trial data and regulatory approval.
• Expansion of clinical trials exploring combination regimens and new indications signifies a growth-oriented pipeline.
• Increasing adoption is driven by molecular diagnostics and the alignment with personalized medicine trends.
• The market potential for Talzenna is substantial, with projections indicating significant growth over the next 5 years, especially if expanded into earlier lines of therapy and other cancer types.
• Competitive landscape remains dynamic; continuous innovation and clinical validation are crucial for maintaining market leadership.

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FAQs

1. What is the primary indication for Talzenna?
   Talzenna is primarily approved for HR+, PIK3CA-mutated advanced or metastatic breast cancer, particularly in combination with fulvestrant.

2. Are there ongoing trials expanding Talzenna's use beyond breast cancer?
   Yes, multiple trials are evaluating Talzenna in gastrointestinal cancers, lung cancers, and in combination with immunotherapies.

3. What are the main safety concerns associated with Talzenna?
   Hyperglycemia, rash, diarrhea, and other metabolic side effects are most common, requiring monitoring and management.

4. How does molecular testing impact Talzenna's market?
   Companion diagnostic testing ensures correct patient selection, enhancing efficacy and driving adoption in precision medicine.

5. What is the outlook for Talzenna’s market growth?
   The drug's market is projected to grow at a CAGR of approximately 12-15% over the next few years, potentially exceeding $2 billion in global sales by 2030.

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References

1. [1] FDA Approval Announcement for Talzenna (alpelisib) and fulvestrant in HR+, HER2- PIK3CA-mutated advanced breast cancer.
2. [2] IQVIA Oncology Market Data, 2022.
3. [3] ClinicalTrials.gov listings on ongoing Talzenna trials.
4. [4] Novartis Investor Presentation, 2023.
5. [5] Industry Analysis on PI3K inhibitors and targeted breast cancer therapies.