CLINICAL TRIALS PROFILE FOR LYNPARZA

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....

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

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

Condition MeSH

Condition MeSH for LYNparza
Intervention	Trials
Breast Neoplasms	37
Carcinoma	33
Ovarian Neoplasms	31
Neoplasms	30

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

Trials by US State

Trials by US State for LYNparza
Location	Trials
California	37
Florida	36
Texas	36
Pennsylvania	30
Massachusetts	29

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

Clinical Trial Status

Clinical Trial Status for LYNparza
Clinical Trial Phase	Trials
Recruiting	71
Not yet recruiting	33
Active, not recruiting	31

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

Sponsor Type

Sponsor Type for LYNparza
Sponsor	Trials
Other	166
Industry	127
NIH	52

Lynparza (olaparib): Clinical Trials Update, Market Analysis, and 2025-2029 Projection

Last updated: April 28, 2026

What is Lynparza’s current clinical development posture?

Lynparza (olaparib) is a PARP inhibitor with an established label in multiple cancer settings and ongoing expansion trials targeting additional combinations and earlier lines. Across the development pipeline, the dominant strategy is extending use across disease stages and pairing with standard-of-care modalities (notably chemotherapy, PI3K pathway agents, androgen-axis therapies, and immune checkpoint inhibitors in selected cohorts).

Core therapeutic areas already supported by approvals

• Ovarian cancer (BRCA-mutated and broader populations depending on prior therapy and biomarker status)
• Breast cancer (including germline BRCA contexts depending on prior therapy)
• Pancreatic cancer (gBRCA and selected molecular profiles)
• Metastatic castration-resistant prostate cancer (mCRPC) (gBRCA and related categories depending on regulatory label)
• Other solid tumor explorations where PARP inhibition overlaps with DNA-damage repair dependencies

Clinical trial directionality (high-level)

• Earlier line expansion: attempts to move olaparib into prior-therapy or maintenance settings.
• Combination intensification: adding systemic partners where mechanistic synergy exists (DNA damage and repair modulation; increased DNA lesions via chemotherapy; or pathway cross-talk).
• Biomarker tightening: continued emphasis on BRCA1/2 (germline and somatic) and homologous recombination deficiency (HRD) where required by protocol designs.

Which ongoing programs most influence near-term market trajectory?

The near-term market outcome for Lynparza is driven by (1) label-consistent uptake in already approved indications, (2) incremental approvals in adjacent subtypes and earlier lines, and (3) the speed at which combination wins convert trial efficacy into regulatory decisions.

At a portfolio level, the trial mix that matters most for revenue acceleration is:

• Maintenance and consolidation trials that convert responders into longer duration treatment
• Therapy line upgrades (moving olaparib earlier)
• Combination wins where response depth and PFS translate into labeling

A critical practical point is that olaparib’s growth rate has historically depended less on “new drug” narratives and more on how quickly trial-positive results become label-ready, then how payers and guideline committees translate new indications into coverage and prescribing.

How does trial performance translate into sales?

For Lynparza, the standard conversion chain used by sponsors, regulators, and payers is:

1. Phase 3 efficacy (OS and PFS endpoints, plus prespecified subgroup robustness)
2. Regulatory label update (country-by-country approval scope and biomarker requirements)
3. Utilization lift via guideline incorporation and clinical pathway adoption
4. Payer uptake driven by comparator position and reduced access friction

Trials that most reliably drive utilization growth are those that:

• Establish benefit in broader patient populations (less restrictive biomarker gates)
• Use regimens that preserve tolerability and feasibility in routine oncology practice
• Create durable treatment durations consistent with oral chronic therapy

What does the market look like today for Lynparza?

Market structure

Lynparza competes in the PARP inhibitor class, with label scope and patient selection rules shaping market share. In oncology, the PARP inhibitor competitive set is defined by:

• Line of therapy
• Biomarker inclusion (gBRCA, sBRCA, HRD)
• Combination versus monotherapy positions
• Tolerability profiles
• Safety-monitoring and discontinuation patterns

Commercial drivers

The commercial demand for Lynparza is supported by:

• Ongoing multi-indication adoption across ovarian and breast cancer and expansions in pancreatic and prostate cancer
• Durable oral dosing economics compared with infusion-based regimens
• Clinician familiarity and established treatment pathways

Key market constraints

• Class competitive pressure (other PARP inhibitors eroding share where label scope overlaps)
• Payer restrictions (biomarker requirements, step therapy, and prior authorization)
• Toxicity and dose management (discontinuation can reduce “effective treated months” versus trial assumptions)
• Treatment sequencing that may cap PARP lifetime use in some workflows

2025-2029 market projection: revenue and growth outlook

Projection approach

This projection models Lynparza’s revenue trajectory as the sum of:

• Base demand from existing labeled indications
• Incremental demand from likely label expansions and guideline changes
• Share dynamics versus PARP competitors
• Time-lag effects from approval to payer adoption and site-level prescribing

The projection below uses a conservative commercial conversion of trial-to-label updates rather than assuming rapid full uptake in all countries or immediate population-wide adoption.

Lynparza revenue projection (global, ex-US included)

Table 1. Lynparza global sales projection (forecast basis: PARP inhibitor market and label utilization)	Year	Projected revenue (USD, $B)	YoY growth
2025	5.7	3%
2026	5.9	4%
2027	6.2	5%
2028	6.5	5%
2029	6.8	5%

How the growth gets generated

• 2025-2026: normalization of utilization in current indications, partial benefits from ongoing trial readouts that translate into label refinements
• 2027-2029: heavier impact from earlier-line and/or combination labeling where adoption barriers are lowest and prescriber confidence is highest

Competitive share expectation

• The base case assumes Lynparza maintains a stable share in core PARP spaces and benefits from its clinical breadth, offset by continued competitive pressure across the class.

Sensitivity: what would change the trajectory?

The market outcome would move most if:

1. A high-confidence regulatory expansion broadens eligibility without adding restrictive biomarker filters.
2. Combination regimens show consistent benefit with manageable tolerability, enabling more lines of therapy.
3. Payer restrictions tighten for PARP inhibitors, reducing treated volumes and duration.
4. Safety signals or higher discontinuation rates reduce “effective use” versus trial dosing.

What is the strategic implication for R&D and investment?

R&D implications

• Priority should be placed on programs that can generate regulatory-ready endpoints with clear clinical benefit across predefined subgroups.
• Trials should be designed to minimize operational friction in routine care (safety, dose durability, and biomarker logistics).
• Development should focus on settings where olaparib can expand beyond current “payer-friendly” workflows.

Investment implications

• Lynparza’s valuation sensitivity concentrates around label expansion velocity and pacing of combination adoption.
• Shortfalls versus plan typically come from payer uptake delays rather than lack of efficacy.

Key Takeaways

• Lynparza’s market is sustained by established multi-indication adoption and ongoing label expansion efforts, with clinical programs oriented toward earlier lines and combination regimens.
• The base case assumes modest but steady global growth through 2029, supported by incremental utilization gains and controlled competitive headwinds.
• The sales trajectory is most sensitive to whether trial outcomes convert into broad eligibility approvals and whether payers allow sustained treatment duration.
• Competitive pressure remains structurally relevant in the PARP inhibitor class, so growth depends on expanding patient pools and treatment lines without increasing access barriers.

FAQs

1) What categories of trials matter most for Lynparza growth?

Phase 3 programs that support earlier-line use, maintenance/consolidation strategies, and combination regimens with clinically durable benefit and manageable tolerability.

2) Does Lynparza growth rely more on new indications or higher uptake in existing ones?

Primarily on incremental utilization in existing labeled spaces, with growth acceleration tied to new or expanded approvals that broaden eligibility and improve guideline adoption speed.

3) What are the largest risks to the 2025-2029 forecast?

Payer access tightening, reduced treated duration from tolerability/dose management, and competitive label overlap that caps share gains in expanding indications.

4) How does the PARP inhibitor competitive landscape affect projections?

Ongoing class competition affects share and pricing, so projected growth assumes Lynparza maintains stable share in core segments while selectively gaining from label expansions.

5) What would most likely accelerate Lynparza revenue beyond the base case?

A regulatory expansion that meaningfully broadens biomarker eligibility and shows consistent combination benefit without increased discontinuation, leading to faster payer approval and wider clinician uptake.

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References (APA)

[1] AstraZeneca. (n.d.). Lynparza (olaparib) prescribing information and product information. https://www.astrazeneca.com/
[2] AstraZeneca. (n.d.). Lynparza clinical trials and pipeline information. https://www.astrazeneca.com/
[3] US Food and Drug Administration. (n.d.). Lynparza (olaparib) approvals and safety communications. https://www.fda.gov/