CLINICAL TRIALS PROFILE FOR ALIQOPA

All Clinical Trials for ALIQOPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02465060 ↗	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Recruiting	National Cancer Institute (NCI)	Phase 2	2015-08-12	This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
NCT03432741 ↗	Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer	Recruiting	National Cancer Institute (NCI)	Phase 1	2018-03-27	This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.
NCT03432741 ↗	Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer	Recruiting	Mayo Clinic	Phase 1	2018-03-27	This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.
NCT03484819 ↗	Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma	Suspended	National Cancer Institute (NCI)	Phase 2	2018-10-19	This phase II trial studies how well copanlisib hydrochloride and nivolumab work in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back (recurrent) or does not responded to the treatment (refractory). Copanlisib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib hydrochloride and nivolumab may work better in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma compared to standard of care.
NCT03842228 ↗	Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations	Recruiting	National Cancer Institute (NCI)	Phase 1	2019-08-12	This phase Ib trial studies side effects and best dose of copanlisib and olaparib when given together with durvalumab, and how well they work in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combinations of copanlisib and olaparib or copanlisib, olaparib, and durvalumab may work better in treating patients with solid tumors compared to usual treatments such as surgery, radiation, or other chemotherapy drugs.

Clinical Trial Conditions for ALIQOPA

Condition Name

Condition Name for ALIQOPA
Intervention	Trials
Advanced Malignant Solid Neoplasm	4
Recurrent Breast Carcinoma	3
Metastatic Breast Carcinoma	3
Refractory Malignant Solid Neoplasm	3

Condition MeSH

Condition MeSH for ALIQOPA
Intervention	Trials
Lymphoma	8
Carcinoma	5
Neoplasms	4
Breast Neoplasms	4

Clinical Trial Locations for ALIQOPA

Trials by Country

Trials by Country for ALIQOPA
Location	Trials
United States	86
Italy	7
Puerto Rico	1
Guam	1

Trials by US State

Trials by US State for ALIQOPA
Location	Trials
Massachusetts	5
Missouri	4
Kentucky	4
New York	4
Minnesota	3

Clinical Trial Progress for ALIQOPA

Clinical Trial Phase

Clinical Trial Phase for ALIQOPA
Clinical Trial Phase	Trials
Phase 2	6
Phase 1/Phase 2	6
Phase 1	4

Clinical Trial Status

Clinical Trial Status for ALIQOPA
Clinical Trial Phase	Trials
Recruiting	10
Not yet recruiting	2
Suspended	2

Clinical Trial Sponsors for ALIQOPA

Sponsor Name

Sponsor Name for ALIQOPA
Sponsor	Trials
National Cancer Institute (NCI)	10
Bayer	5
Dana-Farber Cancer Institute	2

Sponsor Type

Sponsor Type for ALIQOPA
Sponsor	Trials
Other	12
NIH	10
Industry	7

Aliqopa (Copanlisib) Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 3, 2025

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Introduction

Aliqopa (copanlisib) stands as a pivotal drug in the treatment arsenal for certain hematological malignancies, notably relapsed follicular lymphoma (FL) and certain types of indolent non-Hodgkin lymphomas. Developed by Bayer AG, copanlisib is a pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor, with a unique intravenous administration route distinguishing it from oral counterparts. As targeted therapies increasingly dominate oncology markets, understanding its clinical development landscape, market positioning, and future growth trajectory becomes essential for stakeholders.

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Clinical Trials Landscape

Current Clinical Development Status

Copanlisib's clinical pipeline is characterized by extensive trials exploring its safety, efficacy, and combinatorial potential across hematological and solid tumor indications. The myopic focus remains on non-Hodgkin lymphomas (NHL), chronic lymphocytic leukemia (CLL), and certain solid tumors.

• Regulatory Approvals:
  In 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Aliqopa for relapsed follicular lymphoma in patients who have received at least two prior systemic therapies. This approval was primarily based on Phase II trial data demonstrating an overall response rate (ORR) of approximately 45% [1].

• Ongoing Trials:
  Bayer continues to pursue Phase III trials and combination studies. Notably, the CHRONOS-4 trial (NCT02367037) evaluates copanlisib with rituximab versus placebo with rituximab in relapsed indolent NHL. Additionally, studies like NCT03165966 assess copanlisib in combination with other agents across various hematologic malignancies.

• Solid Tumor Trials:
  Less advanced in solid tumor indications, with early-phase trials examining safety and preliminary efficacy in breast, gastric, and other cancers, though these do not currently impact the primary market.

Efficacy and Safety Profile

Clinical data affirm copanlisib's efficacy, notably in heavily pretreated populations, with manageable safety profiles. The most common adverse events include hyperglycemia, hypertension, diarrhea, and fatigue, which align with its mechanism targeting PI3K pathways [2]. These safety considerations influence its clinical positioning and patient selection.

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Market Analysis

Market Overview

The PI3K inhibitor landscape is competitive, with copanlisib sharing space with oral agents like idelalisib (Gilead Sciences) and duvelisib (Secura Bio). The intravenous administration of Aliqopa offers a differentiated mode, potentially benefiting patients with compliance issues related to oral drugs and influencing utilization patterns in clinical settings.

• Market Penetration and Sales:
  Since approval, Aliqopa's sales have experienced modest but steady growth, influenced by expanding indications and clinical familiarity. In 2022, Bayer reported sales figures of approximately €125 million globally, with the U.S. accounting for the majority due to its initial approval there [3].

• Key Market Drivers:

  • Increasing prevalence of NHL globally.
  • Growing adoption of targeted therapies in oncology.
  • Expansion into combination regimens showing improved efficacy.

• Market Challenges:

  • Competition from oral PI3K inhibitors with higher convenience.
  • Safety concerns associated with class effects, including immune-mediated adverse events.
  • Limited penetration outside approved indications due to safety management complexity.

Regional Dynamics

North America remains the largest market attributed to early adoption and regulatory approval. Europe and Asia-Pacific show potential growth, driven by increasing oncology awareness and healthcare infrastructure development.

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Future Market Projections

Growth Opportunities

• Expansion of Indications:
  Bayer is likely to pursue additional approvals, especially for combination therapies in larger trials, such as CHRONOS-5 or other pivotal studies aimed at solid tumors or broader lymphoma subtypes.

• Combination Therapies:
  Collaborations with immunotherapies (e.g., checkpoint inhibitors) and chemotherapies could expand copanlisib’s use cases, opening new revenue streams.

• Biomarker-Driven Use:
  The development of predictive biomarkers could optimize patient selection, increasing treatment efficacy and adoption rates.

Market Forecast (2023–2030)

Based on current clinical trajectory and competitive landscape, the global copanlisib market is projected to witness a compound annual growth rate (CAGR) of approximately 8–10%. The market could reach USD 400–500 million annually by 2030, contingent upon successful indication expansion and increased utilization in combination settings.

An important caveat involves competition from emerging PI3K inhibitors and novel therapeutic classes, which may influence market share. Nevertheless, Aliqopa's intravenous route and safety profile may secure niche advantages in specific patient subsets.

Risks and Uncertainties

• Safety concerns necessitate vigilant management; adverse events could hamper market expansion.
• Regulatory barriers in emerging markets could delay deployment.
• The evolving competitive landscape with oral PI3K inhibitors may challenge market share.

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Conclusion

Aliqopa continues to carve out a significant position within the hematological oncology space, supported by robust clinical data and regulatory endorsements. Its clinical trials landscape remains active, with ongoing studies poised to unlock expanded indications and improved combination therapies. Market potential remains promising, driven by the increasing need for targeted treatments in relapsed NHL and beyond.

By leveraging its intravenous formulation, safety profile, and ongoing clinical validation, Bayer can enhance Aliqopa's commercial footprint. Strategic focus on indication expansion, biomarker development, and combination regimens will be crucial in sustaining competitive advantage and unlocking its full market potential.

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Key Takeaways

• Aliqopa's efficacy in relapsed follicular lymphoma established its initial market success, with potential to expand to other indications.
• Ongoing pivotal trials, including combination studies, are critical for its future regulatory and commercial trajectory.
• The drug’s intravenous administration offers a niche advantage over oral competitors but must balance safety management.
• Market growth projections are optimistic but hinge on successful indication expansion and safety profile management.
• Competitive pressure from oral PI3K inhibitors and emerging therapies necessitates strategic positioning emphasizing Aliqopa's strengths.

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FAQs

1. What is the primary mechanism of action of Aliqopa?
   Aliqopa (copanlisib) inhibits class I PI3K enzymes, disrupting signaling pathways vital for tumor cell proliferation and survival, primarily used in certain lymphomas.

2. What indications are approved for Aliqopa?
   The FDA approves Aliqopa for relapsed follicular lymphoma in patients who have received at least two prior systemic therapies.

3. Are there ongoing clinical trials for indications beyond follicular lymphoma?
   Yes. Bayer invests in trials exploring copanlisib for other indolent NHL subtypes, combination therapies, and preliminary solid tumor studies.

4. How does Aliqopa compare to oral PI3K inhibitors?
   Aliqopa’s intravenous formulation offers an alternative for patients with compliance issues or gastrointestinal concerns, although safety profiles remain similar with class-specific adverse events.

5. What are the key challenges facing Aliqopa’s market expansion?
   Challenges include safety management, competition from oral agents, regulatory hurdles in emerging markets, and the need for broader indication approvals.

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Sources:

[1] U.S. Food and Drug Administration (FDA). Aliqopa (copanlisib) prescribing information. 2017.
[2] Banerjee M, et al. "Safety and Efficacy of Copanlisib in Hematology." Journal of Hematology Oncology. 2019.
[3] Bayer AG Annual Report 2022.