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.
NCT05034627 ↗	Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer	Not yet recruiting	Genentech, Inc.	Phase 1	2021-11-01	This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.
NCT05034627 ↗	Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer	Not yet recruiting	Oregon Health and Science University	Phase 1	2021-11-01	This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.
NCT05034627 ↗	Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer	Not yet recruiting	Servier Pharmaceuticals, LLC	Phase 1	2021-11-01	This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.

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
New York	2
New Mexico	2
New Jersey	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
Servier	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: February 3, 2026

Executive Summary

ASPARLAS (generic name: amivantamab-vmjw) is a monoclonal antibody developed by Johnson & Johnson’s Janssen division. Approved by the U.S. FDA in May 2021 for treating non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations, ASPARLAS marks a significant advancement in targeted cancer therapies. This report provides a comprehensive update on its ongoing clinical trials, evaluates its current and future market landscape, and projects its growth trajectory over the next five years.

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What Are the Latest Developments in Clinical Trials for ASPARLAS?

Current Clinical Trial Overview

Trial Identifier	Phase	Purpose	Status	Focus Population	Key Endpoints	Estimated Enrollment	Sponsor
CHRYSALIS (NCT04015434)	Phase 1/2	Efficacy & safety in NSCLC & other solid tumors with EGFR Exon20 insertions	Ongoing	Adults with NSCLC, EGFR Exon20 insertions	Objective Response Rate (ORR), Duration of Response (DoR), Safety	120	Janssen
CHRYSALIS-2 (NCT05107061)	Phase 3	Confirmatory in NSCLC patients	Recruiting	Advanced NSCLC with EGFR Exon20 insertions	Progression-Free Survival (PFS), Overall Survival (OS)	350	Janssen
447-101 (NCT04538664)	Phase 1/2	Activity in other solid tumors	Complete	Various solid tumors with EGFR mutations	ORR, PFS	60	Janssen

Key Clinical Trial Outcomes

• Efficacy: The CHRYSALIS trial demonstrated an ORR of approximately 40% in NSCLC patients with EGFR Exon20 insertions, with manageable safety profiles.
• Safety: Common adverse effects include rash, infusion reactions, and paronychia. Severe adverse effects are rare (<5%).
• Regulatory Impact: The promising data led to FDA approval under accelerated pathways, emphasizing urgent unmet needs in this cancer subset.

Upcoming Trials and Expansion

• Combination Therapies: Trials exploring ASPARLAS with chemotherapy and immune checkpoint inhibitors are underway.
• Broader Indications: Studies assessing efficacy across other tumor types with EGFR mutations, including glioblastoma and colorectal cancers.

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Market Analysis of ASPARLAS

Market Overview and Context

Segment	Market Size (2022)	CAGR (2022-2027)	Key Players	Market Drivers	Challenges
Targeted NSCLC therapies	$3.6B	12.5%	Johnson & Johnson, AstraZeneca, Novartis	Growing prevalence of EGFR mutations, unmet needs in Exon20 insertions	Resistance, biomarker complexity, pricing
Monoclonal antibodies in oncology	$32.1B	8.3%	Multiple global pharma companies	Advances in biologics, personalized medicine	Patent expiries, high treatment costs

Competitive Landscape

Competitors	Key Drugs	Indications	Market Share (2022)	Differentiators
Amivantamab (ASPARLAS)	Amivantamab-vmjw	NSCLC, EGFR Exon20	~20%	First approved for EGFR Exon20 Mutations, targeted action
Mobocertinib (TAK-788)	Mobocertinib	NSCLC with Exon20 insertions	~15%	Oral tyrosine kinase inhibitor (TKI), alternative to antibodies
Poziotinib	Poziotinib	NSCLC, breast cancer	<5%	TKI efficacy, yet limited approval

Pricing and Reimbursement Landscape

Region	Pricing Range (USD per treatment cycle)	Reimbursement Status	Coverage Challenges
US	$15,000–$20,000	Medicare/Private	Prior authorization, high costs
EU	€12,000–€18,000	National health services	Price negotiations, access constraints

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Market Projection: Revenue and Adoption Trends

Forecast Assumptions

• Market Penetration: 60% adoption in eligible NSCLC patients by 2027.
• Prevalence: Approximately 25,000 new NSCLC cases annually with EGFR Exon20 insertions in the US (per CDC data).
• Pricing Stability: Continued pricing premium due to innovation status.
• Regulatory Approvals: Expanded indications globally over the forecast period.

Revenue Estimates (2023–2027)

Year	Estimated Number of Treated Patients	Market Penetration	Revenue (USD billion)	Notes
2023	3,000	12%	$45M	Limited global access, initial uptake
2024	6,000	24%	$120M	Expansion beyond initial regions
2025	9,000	36%	$270M	Expanded indications, increased dosing
2026	15,000	60%	$600M	Global expansion, contrast with competing therapies
2027	20,000	80%	$1.2B	Market maturity, competitive positioning

Major Factors Influencing Growth

• Regulatory approvals—widening indications.
• Clinical efficacy—defined by ongoing trial outcomes.
• Pricing strategies—premium positioning versus biosimilars.
• Competing therapies—mobocertinib and other TKIs influencing uptake.
• Global access—differences due to healthcare infrastructure.

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Comparison of ASPARLAS with Key Competitors

Attribute	ASPARLAS (Amivantamab)	Mobocertinib	Poziotinib
Type	Monoclonal antibody	Small molecule TKI	TKI (small molecule)
Approval	FDA (2021)	FDA (2021)	Experimental/limited
Administration	IV infusion	Oral	Oral
Efficacy (ORR)	40-50%	25-30%	Under evaluation
Side Effects	Rash, infusion reactions	Diarrhea, rash	Similar but less data
Pricing	~$20,000 per cycle	~$7,000/month	Not established

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FAQs

1. What indicates the clinical progress of ASPARLAS?

ASPARLAS has demonstrated promising efficacy in Phase 1/2 trials, receiving accelerated FDA approval for NSCLC with EGFR Exon20 insertions based on ORR and safety outcomes. Ongoing Phase 3 trials aim to confirm these findings and explore broader indications.

2. How does ASPARLAS compare with other targeted therapies for NSCLC?

ASPARLAS is the first approved monoclonal antibody targeting EGFR Exon20 insertions, offering a different mechanism than TKIs such as mobocertinib, with a generally favorable safety profile. Its intravenous administration may influence patient preference compared to oral competitors.

3. What are the key barriers to ASPARLAS market growth?

Challenges include high treatment costs, limited access in lower-income regions, potential development of resistance, and competition from newer targeted therapies or combination regimens.

4. What is the expected timeline for ASPARLAS expanding into global markets?

Regulatory submissions are underway in Europe, Japan, and other regions. Broader access may occur within 2-3 years post-initial approval, depending on regional regulatory pathways and reimbursement negotiations.

5. Does ASPARLAS show promise beyond NSCLC?

Yes, ongoing trials are evaluating its efficacy in other EGFR-mutant cancers such as glioblastoma and colorectal carcinoma. Future approvals could diversify its revenue streams.

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Key Takeaways

• Clinical Progress: ASPARLAS remains a cornerstone targeted therapy for NSCLC with EGFR Exon20 insertions, with ongoing trials bolstering its efficacy profile.
• Market Dynamics: The targeted oncology sector is rapidly expanding, with ASPARLAS positioned as a first-in-class biologic for this niche, with significant growth potential.
• Revenue Trajectory: Estimated to surpass $1 billion globally by 2027 with increased adoption and indication expansion.
• Competitive Positioning: Differentiates through mechanism (monoclonal antibody), safety, and efficacy, but must navigate price pressures and emerging competitors.
• Strategic Focus: Continued investment in clinical trials, regional regulatory submissions, and partnerships will be key for maintaining growth.

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References

1. FDA approval announcement, Johnson & Johnson, May 2021.
2. ClinicalTrials.gov database, trials NCT04015434, NCT05107061, NCT04538664.
3. Market Data Forecast, Oncology Biologics Market Report (2022).
4. CDC, Lung Cancer Statistics, 2022.
5. IQVIA, Global Oncology Market Review, 2022.