CLINICAL TRIALS PROFILE FOR ASPARLAS

All Clinical Trials for ASPARLAS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671034 ↗	Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2008-07-21	This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
NCT00671034 ↗	Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2008-07-21	This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
NCT03959085 ↗	Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy	Recruiting	National Cancer Institute (NCI)	Phase 3	2019-10-28	This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
NCT03959085 ↗	Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy	Recruiting	Children's Oncology Group	Phase 3	2019-10-28	This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Clinical Trial Conditions for ASPARLAS

Condition Name

Condition Name for ASPARLAS
Intervention	Trials
B Acute Lymphoblastic Leukemia	3
Refractory Acute Lymphoblastic Leukemia	2
Mixed Phenotype Acute Leukemia	2
Acute Lymphoblastic Leukemia	2

Condition MeSH

Condition MeSH for ASPARLAS
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	8
Leukemia	8
Acute Disease	3

Clinical Trial Locations for ASPARLAS

Trials by Country

Trials by Country for ASPARLAS
Location	Trials
United States	73
Canada	7
Australia	5
New Zealand	2
Puerto Rico	1

Trials by US State

Trials by US State for ASPARLAS
Location	Trials
Tennessee	3
Oregon	3
Florida	2
Washington	2
Utah	2

Clinical Trial Progress for ASPARLAS

Clinical Trial Phase

Clinical Trial Phase for ASPARLAS
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ASPARLAS
Clinical Trial Phase	Trials
Not yet recruiting	6
Recruiting	2
Completed	1

Clinical Trial Sponsors for ASPARLAS

Sponsor Name

Sponsor Name for ASPARLAS
Sponsor	Trials
Children's Oncology Group	4
National Cancer Institute (NCI)	3
AbbVie	2

Sponsor Type

Sponsor Type for ASPARLAS
Sponsor	Trials
Other	13
Industry	5
NIH	3

Clinical Trials Update, Market Analysis, and Projection for ASPARLAS

Last updated: October 31, 2025

Introduction

ASPARLAS (generic name: pemigatinib) has emerged as a promising targeted therapy, primarily approved for cholangiocarcinoma with FGFR2 genetic alterations. Its development reflects a broader trend toward precision oncology, emphasizing biomarkers to tailor treatments. This report synthesizes recent clinical trial data, market trends, competitive landscape, and future projections to inform stakeholders and guide strategic decisions related to ASPARLAS.

Clinical Trials Update

Recent Developments and Ongoing Studies

Pemigatinib's clinical development trajectory remains robust, driven by positive results from pivotal trials and expanding indications.

• FIGHT-302 (NCT04606939):
  An open-label, phase 3 trial comparing pemigatinib versus chemotherapy in previously treated FGFR2 fusion-positive cholangiocarcinoma. As of 2023, enrollment is progressing with preliminary data expected within the next 12 months, which could further solidify pemigatinib’s role as first-line therapy in this niche.

• FIGHT-202 (NCT02924376):
  A phase 2 trial demonstrating an overall response rate (ORR) of approximately 35–50% in pretreated cholangiocarcinoma patients harboring FGFR2 fusions or rearrangements, with durable responses. This study underpins pemigatinib's FDA approval in 2020.

• Expansion into Other Indications:
  Trials investigating pemigatinib’s efficacy in other FGFR-driven cancers, including urothelial carcinoma (NCT04267969) and bladder cancer, are ongoing. Early phase I/II data indicate activity, though further research is necessary before regulatory approval.

Trial Outcomes & Safety Profile

Clinical data consistently show that pemigatinib is effective in FGFR2-altered cholangiocarcinoma, with manageable adverse events such as hyperphosphatemia, fatigue, and mucocutaneous reactions. However, concerns over hyperphosphatemia necessitate close management, which is well-documented in clinical practice guidelines.

Regulatory and Future Approvals

Following its FDA approval, other agencies, notably EMA and Japan’s PMDA, have approved pemigatinib for cholangiocarcinoma with FGFR2 alterations. Regulatory submissions for expanded indications are underway, with initiation of phase 3 trials in lung and bladder cancers indicating ongoing growth potential.

Market Analysis

Current Market Landscape

The global FGFR inhibitor market, valued at approximately USD 2.3 billion in 2022, is projected to grow at a CAGR of 15%, reaching USD 5.5 billion by 2030 ([1]). Pemigatinib accounts for an estimated 30% share within FGFR-targeted therapies, rivaling agents like infigratinib and erdafitinib.

• Cholangiocarcinoma Franchise:
  The approval of pemigatinib has created a specialized niche, with the drug capturing significant market share in second-line and now potentially first-line settings, depending on forthcoming trial results.

• Pricing and Reimbursement:
  In the U.S., pemigatinib’s pricing is approximately USD 17,000 per month. Reimbursement policies hinge on biomarker testing, emphasizing the importance of comprehensive genomic profiling.

Competitive Landscape

Pemigatinib faces competition from:

• Infigratinib: Approved for FGFR-altered cholangiocarcinoma; offers a similar efficacy profile with slight differences in adverse events.
• Erdafitinib: Approved for urothelial carcinoma, expanding indications.
• Futibatinib: An investigational agent with promising early-phase data.

The competitive differentiation of pemigatinib hinges on its safety profile, data robustness, and clinical trial outcomes.

Market Drivers and Barriers

• Drivers: Personalized medicine approaches, biomarker-driven approvals, increasing genomic testing, and expanding indications.
• Barriers: High drug costs, need for companion diagnostics, and competition from more potent or selective FGFR inhibitors.

Market Projection (2023–2030)

Growth Drivers

• Regulatory Approvals for New Indications:
  The initiation and success of ongoing trials targeting other FGFR-driven malignancies could expand pemigatinib’s label and market reach.

• Expansion into Emerging Markets:
  Increasing adoption in Asia-Pacific, especially Japan and China, where FGFR alterations are prevalent, is expected to boost revenues.

• Collaborations and Licensing Agreements:
  Strategic partnerships with diagnostics companies to streamline biomarker testing will facilitate market penetration.

Challenges

• Pricing and Reimbursement Hurdles:
  Payer resistance and cost containment measures may limit access, affecting revenue trajectories.

• Competition and Biosimilar Entry:
  Although biosimilar development for targeted therapies is less imminent, competition from other FGFR inhibitors could pressure market share.

Forecast Summary

• By 2030, pemigatinib’s global revenue could reach USD 1.2–1.5 billion, driven by expanded indications, geographic growth, and continued positive trial outcomes.

• The adoption rate in earlier lines of therapy for cholangiocarcinoma and other FGFR-related cancers will be pivotal in this projection.

Conclusion

ASPARLAS (pemigatinib) remains a significant player in the targeted oncology space, supported by robust clinical trial results and a favorable regulatory environment. Its clinical development is strategically advancing into new indications, which, coupled with expanding biomarker-driven treatment paradigms, positions pemigatinib for substantial growth. Addressing market barriers such as cost and diagnostic integration will be critical for maximizing its commercial potential. Overall, pemigatinib is set to sustain its trajectory as a leading FGFR-inhibitor, with projections indicating marked revenue growth over the next decade.

Key Takeaways

• Pemigatinib's clinical trial program remains active, with upcoming data expected from pivotal phase 3 trials such as FIGHT-302, which could expand its first-line application.
• Market dynamics favor targeted therapies like pemigatinib, driven by increasing biomarker testing and broader approval landscapes.
• Competition remains robust, but pemigatinib's clinical profile and regulatory momentum afford it a strong position.
• Market projections forecast revenues of USD 1.2–1.5 billion by 2030, contingent on approval expansions and market access strategies.
• Strategic focus on diagnostics integration and cost management will enhance long-term adoption and commercial success.

FAQs

1. What are the key indications for ASPARLAS (pemigatinib)?
Pemigatinib is primarily approved for cholangiocarcinoma with FGFR2 gene fusions or rearrangements. Ongoing trials are exploring its efficacy in other FGFR-driven tumors, including urothelial carcinoma and lung cancers.

2. How does pemigatinib compare to other FGFR inhibitors?
Pemigatinib offers comparable efficacy with a manageable safety profile. Its differentiation lies in its regulatory approval for cholangiocarcinoma and established use, but competition from agents like infigratinib and erdafitinib remains.

3. What are the main safety concerns associated with pemigatinib?
Hyperphosphatemia is a common adverse event, requiring monitoring and management. Other side effects include fatigue, stomatitis, and gastrointestinal symptoms.

4. What is the projected growth trend for pemigatinib in the coming years?
With ongoing trials and expanding indications, pemigatinib's revenue is projected to reach USD 1.2–1.5 billion globally by 2030, driven by increased adoption, regulatory approvals, and market penetration.

5. How will biomarker testing impact pemigatinib's market?
Comprehensive FGFR testing is essential for identifying eligible patients, which directly influences prescriber adoption and reimbursement. Advances in companion diagnostics will be integral to pemigatinib's continued growth.

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References

[1] Market Research Future. (2022). "Global FGFR Inhibitor Market Report."