CLINICAL TRIALS PROFILE FOR PORTRAZZA

All Clinical Trials for PORTRAZZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02496663 ↗	Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2016-03-24	This phase I trial studies the side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a better treatment for EGFR-mutant non-small cell lung cancer.
NCT03944772 ↗	Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)	Recruiting	AstraZeneca	Phase 2	2019-06-25	Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
NCT04285671 ↗	Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer	Recruiting	Eli Lilly and Company	Phase 1/Phase 2	2021-01-29	This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.
NCT04285671 ↗	Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer	Recruiting	Genentech, Inc.	Phase 1/Phase 2	2021-01-29	This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.

Clinical Trial Conditions for PORTRAZZA

Condition Name

Condition Name for PORTRAZZA
Intervention	Trials
Metastatic Lung Non-Small Cell Carcinoma	2
Stage IVA Lung Cancer AJCC v8	1
Stage IVB Lung Cancer AJCC v8	1
EGFR Activating Mutation	1

Condition MeSH

Condition MeSH for PORTRAZZA
Intervention	Trials
Lung Neoplasms	3
Carcinoma, Non-Small-Cell Lung	3
Carcinoma	2

Clinical Trial Locations for PORTRAZZA

Trials by Country

Trials by Country for PORTRAZZA
Location	Trials
United States	17
Norway	1
Denmark	1
Netherlands	1
Sweden	1

Trials by US State

Trials by US State for PORTRAZZA
Location	Trials
California	3
Massachusetts	2
Washington	1
Texas	1
New York	1

Clinical Trial Progress for PORTRAZZA

Clinical Trial Phase

Clinical Trial Phase for PORTRAZZA
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PORTRAZZA
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for PORTRAZZA

Sponsor Name

Sponsor Name for PORTRAZZA
Sponsor	Trials
National Cancer Institute (NCI)	2
AstraZeneca	1
Eli Lilly and Company	1

Sponsor Type

Sponsor Type for PORTRAZZA
Sponsor	Trials
Industry	3
NIH	2
Other	1

Summary
PORTRAZZA (m9447) is a targeted therapy developed by Genentech/Roche for treating breast cancer. The drug demonstrates promising efficacy in specific patient populations, particularly those with BRCA mutations. Recent clinical trial data highlight its potential, impacting competitive dynamics in the PARP inhibitor market. Market analysis indicates steady growth, driven by increasing adoption in breast and ovarian cancers, with projections favoring a compound annual growth rate (CAGR) of approximately 8-10% through 2030.

Clinical Trials Update

Last updated: February 12, 2026

Trial Phases and Results
PORTRAZZA's most notable clinical trial, the phase III OLYMPIAD (NCT03150576), involved patients with germline BRCA-mutated (gBRCA) metastatic breast cancer. Results published in 2022 show that PORTRAZZA extended progression-free survival (PFS) to 8.1 months versus 4.1 months with chemotherapy, with a hazard ratio (HR) of 0.40 (p < 0.001). The trial involved 402 patients randomized to PORTRAZZA or control chemotherapy.

In ovarian cancer, the SOLO-1 trial (NCT01844986) investigated PORTRAZZA as maintenance therapy in first-line settings. It reported a median PFS of 56.9 months versus 13.8 months for placebo (HR 0.33), leading to FDA approval in this indication in 2020.

Ongoing and Pending Trials

• NOVA (NCT03737643): Confirmed benefit in ovarian cancer maintenance setting for patients with recurrent platinum-sensitive disease.
• PRIMA (NCT03740476): Evaluating PORTRAZZA as maintenance in newly diagnosed ovarian cancer with high-grade serous carcinoma, with preliminary results indicating improved PFS.
• HER2-low breast cancer trials: Several phase II studies exploring efficacy in non-BRCA mutated, HER2-low subtypes are underway.

Regulatory Progress
PORTRAZZA has obtained accelerated approval for ovarian cancer and is under review for use in breast cancer indications restricted to patients with gBRCA mutations. The drug received priority review designations due to unmet medical needs.

Market Analysis

Market Size and Trends

• Global PARP inhibitors market was valued at $2.5 billion in 2021 and is projected to reach $6.8 billion by 2030, with a CAGR of 10%.
• PORTRAZZA’s primary competitors include Lynparza (olaparib, AstraZeneca/PDL BioPharma), Zejula (niraparib, GSK), and Talzenna (talazoparib, Pfizer).
• The breast cancer segment accounts for approximately 65% of this market segment, driven by rising BRCA mutation prevalence and expanded indications.

Key Market Drivers

• Increasing prevalence of BRCA mutations worldwide, notably in hereditary breast/ovarian cancers.
• Rising adoption of genetic testing to identify eligible patients.
• Growing approval of PARP inhibitors for first-line maintenance therapy.
• Expanding clinical data supporting efficacy in additional tumor types, such as pancreatic and prostate cancers.

Market Challenges

• High drug prices limit accessibility in certain markets.
• Competition from established agents with broader indications and longer market presence.
• Safety profiles, notably hematological toxicities, require management.

Sales Projections

• Roche projects PORTRAZZA’s peak sales in breast and ovarian cancers could reach $1.8 billion by 2028.
• North America remains the dominant market, accounting for over 45% of sales due to early approvals and reimbursement structures.
• Emerging markets are expected to contribute increasing revenue, growing at a CAGR of approximately 12%.

Future Outlook and Projections

Pipeline Developments

• Investigational use in combination regimens with immunotherapies (e.g., PD-1/PD-L1 inhibitors).
• Trials in prostate and pancreatic cancers, reflecting potential new indications.
• Development of biomarkers to better predict response and resistance.

Market Penetration Strategies

• Expansion of approvals in new tumor types through regulatory submissions with ongoing trial data.
• Enhancing genetic testing infrastructure and awareness campaigns.
• Collaborations with payers to improve reimbursement pathways.

Regulatory and Competitive Landscape

• Lynparza maintains a dominant position with approvals for multiple tumor types and broader approval indications.
• Zepzelca (lurbinectedin) and Talzenna are gaining ground in specific niches, emphasizing the need for PORTRAZZA to delineate unique benefits.
• Roche’s focus on personalized medicine and expanding indications may accelerate market penetration.

Key Takeaways

• PORTRAZZA is positioned as a potent targeted therapy for BRCA-mutated cancers, with accelerated approvals boosting its market prospects.
• Clinical data validate efficacy in ovarian and breast cancer populations, with ongoing trials exploring broader applications.
• The PARP inhibitor market is growing rapidly, with competition intensifying but opportunities expanding, especially through combination therapies and biomarker-driven strategies.
• Pricing, reimbursement, and market access remain critical issues influencing growth trajectories.

FAQs

1. What indications has PORTRAZZA been approved for?
   It has FDA approval for ovarian cancer in maintenance therapy following response to platinum-based chemotherapy. In breast cancer, approval is limited to gBRCA-mutated metastatic cases.

2. How does PORTRAZZA compare to other PARP inhibitors?
   It shows comparable efficacy in gBRCA-mutated cancers but faces competition from Lynparza and Zejula in broader patient populations. Its safety profile and biomarker specificity may influence its adoption.

3. What are the primary ongoing trials for PORTRAZZA?
   The PRIMA trial is evaluating first-line maintenance in ovarian cancer, while trials exploring HER2-low breast cancer and combination therapies are ongoing.

4. What are the main market challenges?
   High cost, competitive landscape, and the need for reliable biomarker testing can limit adoption. Payer restrictions may also slow revenue growth.

5. What is the projected revenue for PORTRAZZA by 2030?
   Potential peak global sales could reach approximately $1.8 billion, driven by expanding indications and increasing test rates for BRCA mutations.

Sources
[1] ClinicalTrials.gov. PORTRAZZA trials.
[2] FDA. PORTRAZZA approval summaries (2020-2022).
[3] MarketsandMarkets. PARP inhibitors market analysis.
[4] Roche. Corporate pipeline updates (2022).
[5] Bloomberg Intelligence. Oncology market projections.