~ Buy the TALZENNA (talazoparib tosylate) Drug Profile, 2024 PDF Report in the Report Store ~

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
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
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 Market Analysis and Financial Projection

TALZENNA: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to TALZENNA

TALZENNA, also known as talazoparib, is a poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer. It has been approved by the FDA for the treatment of certain types of breast and prostate cancers, particularly those associated with BRCA mutations.

Clinical Trial Results for Breast Cancer

Patient Population and Trial Design

TALZENNA was studied in a clinical trial involving 431 patients with germline BRCA-mutated, human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/MBC). These patients had previously received up to three rounds of chemotherapy and had no prior PARP inhibitor therapy. The trial divided patients into two groups: one receiving TALZENNA and the other receiving the healthcare provider’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine)[1][2].

Efficacy Outcomes

The trial demonstrated that TALZENNA was significantly more effective at delaying disease progression compared to chemotherapy. Patients on TALZENNA experienced a median progression-free survival (PFS) of 8.6 months, whereas those on chemotherapy had a median PFS of 5.6 months. This translates to a 46% reduction in the risk of cancer progression for patients taking TALZENNA[1][2].

Tumor Response

The tumor response rate was also significantly higher in the TALZENNA group, with 50.2% of patients showing a response (complete or partial), compared to 18.4% in the chemotherapy group. Notably, 5.5% of patients on TALZENNA achieved a complete response, whereas no patients on chemotherapy did so[1].

Clinical Trial Results for Prostate Cancer

Combination Therapy with Xtandi

In the context of metastatic castration-resistant prostate cancer (mCRPC), TALZENNA has shown promising results when combined with Xtandi (enzalutamide). The TALAPRO-2 trial demonstrated that this combination significantly improved overall survival and progression-free survival. Patients with homologous recombination repair (HRR) gene mutations benefited particularly, with a 54% reduction in the risk of progression or death[3][4].

Safety Profile

The safety profile of TALZENNA plus Xtandi was consistent with previous reports for both drugs, with no new safety signals identified. This combination has been approved by the FDA for the treatment of mCRPC in patients with HRR gene mutations[4].

Market Analysis

Competitive Landscape

Pfizer entered the PARP inhibitor market with TALZENNA, which was approved in 2018 for BRCA-mutated, HER2-negative breast cancer. However, the market is highly competitive, with other players like AstraZeneca and Merck’s Lynparza, Tesaro’s Zejula, and Clovis Oncology’s Rubraca already established. Each of these drugs has its own strengths and weaknesses, including differences in side effect profiles and approved indications[2][3].

Market Challenges

One of the challenges for TALZENNA is its side effect profile, particularly the unique side effect of hair loss, which is not seen with other PARP inhibitors. Analysts have expressed concerns about how this might impact patient preference and market share[2].

Expansion Strategies

To gain a competitive edge, Pfizer is exploring various combination therapies and expanding TALZENNA’s indications beyond breast cancer. For example, Pfizer is testing TALZENNA in combination with Array Biopharma’s MEK inhibitor for non-small cell lung cancer and pancreatic cancer, and it has a phase 3 program underway for ovarian cancer and prostate cancer[2][3].

Market Projections

Revenue Growth

TALZENNA has shown significant revenue growth, with a 77% year-over-year increase reported in 2024. This growth is partly driven by the drug’s expanding indications and positive clinical trial results, particularly in the combination therapy with Xtandi for mCRPC[5].

Future Indications

Pfizer is actively working on expanding TALZENNA’s market beyond its current indications. The company’s pipeline includes several ongoing clinical studies, such as the Phase 3 TALAPRO study, which has shown significant overall survival benefits. These efforts are expected to further boost TALZENNA’s market presence and revenue[5].

Key Takeaways

• Clinical Efficacy: TALZENNA has demonstrated significant efficacy in delaying disease progression and improving tumor response rates in breast cancer and mCRPC.
• Combination Therapy: The combination of TALZENNA with Xtandi has shown promising results in mCRPC, offering a new treatment option for patients with HRR gene mutations.
• Market Competition: Despite entering a competitive market, TALZENNA has carved out a niche with its unique clinical benefits and is expanding its indications to gain further market share.
• Revenue Growth: TALZENNA has experienced substantial revenue growth and is expected to continue this trend with ongoing clinical successes and market expansions.

FAQs

Q: What is TALZENNA used for?

TALZENNA is used to treat certain types of breast and prostate cancers, particularly those associated with BRCA mutations.

Q: How does TALZENNA compare to other PARP inhibitors in breast cancer?

TALZENNA has shown a 46% reduction in the risk of disease progression compared to chemotherapy and has a higher tumor response rate than chemotherapy. However, it faces competition from other PARP inhibitors like Lynparza and Zejula, each with their own clinical profiles and side effect profiles[1][2].

Q: What are the key findings of the TALAPRO-2 trial for prostate cancer?

The TALAPRO-2 trial demonstrated that the combination of TALZENNA and Xtandi significantly improved overall survival and progression-free survival in patients with mCRPC and HRR gene mutations[3][4].

Q: What are the common side effects of TALZENNA?

TALZENNA has a side effect profile that includes hair loss, which is unique among PARP inhibitors. Other side effects are generally consistent with those of other PARP inhibitors[2].

Q: What are Pfizer’s plans for expanding TALZENNA’s indications?

Pfizer is testing TALZENNA in various combination therapies and expanding its indications to include non-small cell lung cancer, pancreatic cancer, ovarian cancer, and further indications in prostate cancer[2][3].

References

1. Learn About TALZENNA® (talazoparib) | Safety Info. Talzenna.
2. Can Pfizer's new breast cancer drug Talzenna really make a dent in .... FiercePharma.
3. Pfizer's Talzenna staves off prostate cancer in showdown with AZ, J&J. FiercePharma.
4. Talzenna Plus Xtandi Shows Significant Overall Survival .... Applied Clinical Trials Online.
5. Pfizer: 4 Reasons to Buy The Pharma Giant Going Into 2025. Investing.com.