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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR LYNPARZA


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505(b)(2) Clinical Trials for Lynparza

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT04538378 ↗ Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors Recruiting National Cancer Institute (NCI) Phase 2 2021-07-07 Background: Lung cancers with EGFR mutations may develop resistance to therapies targeting this protein by evolving/being transformed into small cell or neuroendocrine cancers. There are no standard treatments for it. Researchers want to see if a new combination of drugs can help. Objective: To see if the combination of durvalumab and olaparib will cause tumors to shrink. Eligibility: Adults age 18 and older who had EGFR-mutated non-small-cell lung carcinoma (NSCLC) that was treated and now transformed to SCLC or another neuroendocrine tumor. Design: Participants will be screened under a separate protocol. They may have a tumor biopsy. Participants will have a physical exam. They will have a review of their symptoms, their medicines, and their ability to do their normal activities. They will have blood tests. They will have an electrocardiogram to evaluate their heart. Participants will have a computed tomography (CT) scan, a series of x-rays taken of parts of the body. Participants will get durvalumab on Day 1 of each 28-day cycle. It is given through a small plastic tube that is put in an arm vein. They will take olaparib by mouth twice every day. They will keep a medicine diary. Participants will take the study drugs until their disease gets worse or they have unacceptable side effects. About 30 days after they stop taking the study drugs, participants will have a follow-up visit. Then they will be contacted every 6 months for the rest of their life....
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lynparza

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01116648 ↗ Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2010-03-25 This partially randomized phase I/II trial studies the side effects and the best dose of cediranib maleate and olaparib and to see how well they work compared to olaparib alone in treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer that has returned after a period of improvement (recurrent). Cediranib maleate may help keep cancer cells from growing by affecting their blood supply. Olaparib may stop cancer cells from growing abnormally. The combination of cediranib maleate and olaparib may help to keep cancer from growing.
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting Breast International Group Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting Frontier Science & Technology Research Foundation, Inc. Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting Myriad Genetic Laboratories, Inc. Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
NCT02032823 ↗ Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Active, not recruiting NRG Oncology Phase 3 2014-04-22 Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lynparza

Condition Name

Condition Name for Lynparza
Intervention Trials
Breast Cancer 17
Ovarian Cancer 12
Prostate Cancer 11
Recurrent Primary Peritoneal Carcinoma 9
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Condition MeSH

Condition MeSH for Lynparza
Intervention Trials
Breast Neoplasms 37
Carcinoma 33
Ovarian Neoplasms 31
Neoplasms 30
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Clinical Trial Locations for Lynparza

Trials by Country

Trials by Country for Lynparza
Location Trials
United States 823
Canada 56
Spain 35
Japan 20
United Kingdom 18
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Trials by US State

Trials by US State for Lynparza
Location Trials
California 37
Florida 36
Texas 36
Pennsylvania 30
Massachusetts 29
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Clinical Trial Progress for Lynparza

Clinical Trial Phase

Clinical Trial Phase for Lynparza
Clinical Trial Phase Trials
Phase 4 4
Phase 3 9
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Lynparza
Clinical Trial Phase Trials
Recruiting 71
Not yet recruiting 33
Active, not recruiting 31
[disabled in preview] 17
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Clinical Trial Sponsors for Lynparza

Sponsor Name

Sponsor Name for Lynparza
Sponsor Trials
AstraZeneca 64
National Cancer Institute (NCI) 52
Merck Sharp & Dohme Corp. 12
[disabled in preview] 26
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Sponsor Type

Sponsor Type for Lynparza
Sponsor Trials
Other 166
Industry 127
NIH 52
[disabled in preview] 1
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LYNPARZA (Olaparib): A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to LYNPARZA

LYNPARZA, also known as olaparib, is a poly (ADP-ribose) polymerase (PARP) inhibitor developed by AstraZeneca and Merck (known as MSD outside the United States and Canada). It has been a groundbreaking treatment in various types of cancer, particularly in those with BRCA mutations.

Clinical Trials Update

OlympiA Phase 3 Trial

The OlympiA Phase 3 trial has been a significant milestone for LYNPARZA. This trial evaluated the efficacy and safety of LYNPARZA as a 12-month adjuvant treatment for adult patients with germline BRCA-mutated (gBRCAm), HER2-negative early breast cancer who had completed neoadjuvant or adjuvant chemotherapy. The results showed that 87.5% of patients treated with LYNPARZA were alive at six years, compared to 83.2% in the placebo arm, demonstrating a clinically meaningful prolonged survival benefit[1].

Long-Term Efficacy

The long-term follow-up data from the OlympiA trial, with a median follow-up of 6.1 years, reinforced LYNPARZA's durable efficacy. This trial is coordinated by the Breast International Group (BIG) in partnership with several other organizations, highlighting the collaborative effort in advancing cancer treatment[1].

Other Clinical Trials

LYNPARZA has also shown significant benefits in other clinical trials. For instance, the OlympiAD trial demonstrated its efficacy in treating patients with gBRCAm HER2-negative metastatic breast cancer, showing a significant improvement in progression-free survival (PFS) compared to physician’s choice of chemotherapy[4].

The PROfound trial was the first positive Phase III trial of any PARP inhibitor in metastatic castration-resistant prostate cancer (mCRPC), demonstrating a significant reduction in the risk of disease progression or death[4].

Market Analysis

Market Dominance

LYNPARZA is set to dominate the PARP inhibitor market, according to a report by GlobalData. Despite growing competition, LYNPARZA is predicted to achieve $4 billion in global sales by 2027, capturing over 68% of the global PARP inhibitors market. This dominance is largely due to its approvals in various cancer indications, including ovarian, breast, prostate, and pancreatic cancers[2].

Revenue and Market Share

Most of LYNPARZA's sales come from its use in ovarian and HER2-negative breast cancer treatments. GSK’s PARP inhibitor Zejula (niraparib) is the second major player in the market, with over $1.6 billion in sales and a 28% market share. However, LYNPARZA's strong position in earlier treatment settings has mitigated the impact of recent withdrawals from heavily pretreated patient populations[2].

Patent Protection and Future Outlook

LYNPARZA's patent protection in the U.S. is set to expire in 2028, which is anticipated to lead to a downshift in sales due to generic erosion. However, AstraZeneca is actively involved in ongoing clinical trials and the development of new therapies, such as the experimental selective PARP1 inhibitor saruparib, which could further strengthen their lead in the PARP inhibitor market[2].

Market Projections

Sales Forecast

The market forecast for LYNPARZA is robust, with projected sales of $4 billion by 2027. This forecast is supported by its expanding indications and strong performance in key markets. The report by ResearchAndMarkets.com provides a detailed market assessment for LYNPARZA in pancreatic cancer across major markets, including the U.S., EU4, the UK, and Japan, forecasting significant sales growth through 2032[3].

Emerging Therapies and Competition

The market for pancreatic cancer, where LYNPARZA is also indicated, is expected to grow significantly due to extensive research and incremental healthcare spending. However, LYNPARZA will face competition from other emerging therapies in pancreatic cancer, which could impact its market share in the future[3].

Regulatory Milestones and Development Activities

LYNPARZA has achieved several regulatory milestones, including approvals in the U.S., European Union, Japan, and many other countries. The ongoing research and development activities, including 123 ongoing phase clinical trials across various cancer types, signify its pivotal role in oncology and potential for future growth[2][3].

Adverse Reactions and Safety Profile

In clinical trials, the most common adverse reactions (≥10%) associated with LYNPARZA include nausea, fatigue, vomiting, and anemia. These side effects are consistent with the broader profile of PARP inhibitors and highlight the need for careful patient monitoring and management[4].

Expert Perspectives

Dr. Filipa Lynce, an Assistant Professor at Harvard Medical School and a Senior Physician at Dana-Farber Cancer Institute, emphasizes the clinical benefits of LYNPARZA in patients with early breast cancer and BRCA-associated cancers. Her perspective underscores the importance of novel therapies in transforming cancer treatment[4].

Key Takeaways

  • Clinical Efficacy: LYNPARZA has demonstrated significant clinical benefits in various cancer types, including early breast cancer, metastatic breast cancer, and prostate cancer.
  • Market Dominance: LYNPARZA is predicted to dominate the PARP inhibitor market with projected sales of $4 billion by 2027.
  • Market Projections: Despite patent expiration in 2028, ongoing clinical trials and new therapies are expected to maintain LYNPARZA's strong market position.
  • Safety Profile: Common adverse reactions include nausea, fatigue, vomiting, and anemia, highlighting the need for careful patient management.
  • Regulatory Milestones: LYNPARZA has achieved multiple regulatory approvals across various countries and indications.

FAQs

What is LYNPARZA used for?

LYNPARZA is used for the treatment of various cancers, including germline BRCA-mutated early breast cancer, metastatic breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer.

What are the key findings from the OlympiA Phase 3 trial?

The OlympiA trial showed that 87.5% of patients treated with LYNPARZA were alive at six years, compared to 83.2% in the placebo arm, demonstrating a clinically meaningful prolonged survival benefit.

How does LYNPARZA compare to other PARP inhibitors in the market?

LYNPARZA is set to dominate the PARP inhibitor market, capturing over 68% of the global market share by 2027, ahead of competitors like GSK’s Zejula.

What is the impact of patent expiration on LYNPARZA’s sales?

The patent protection for LYNPARZA in the U.S. expires in 2028, which is anticipated to lead to a downshift in sales due to generic erosion.

What are the common adverse reactions associated with LYNPARZA?

Common adverse reactions include nausea, fatigue, vomiting, and anemia, which are consistent with the broader profile of PARP inhibitors.

Sources

  1. Merck News: LYNPARZA® (olaparib) Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer in OlympiA Phase 3 Trial.
  2. FiercePharma: AstraZeneca and Merck's Lynparza set to 'dominate' PARP market.
  3. Business Wire: LYNPARZA Market Drug Insight and Market Forecast 2023 - 2032.
  4. Onclive: LYNPARZA® (olaparib): 10 Years Dedicated to Transforming Certain Types of Cancer.

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