CLINICAL TRIALS PROFILE FOR LONSURF

505(b)(2) Clinical Trials for LONSURF

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	NCT07235293 ↗	A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.	NOT_YET_RECRUITING	Novotech (Australia) Pty Limited	PHASE2	2025-11-15	This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
New Combination	NCT07235293 ↗	A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.	NOT_YET_RECRUITING	Kahr Bio Australia Pty Ltd	PHASE2	2025-11-15	This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.

All Clinical Trials for LONSURF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Astex Pharmaceuticals, Inc.	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Van Andel Research Institute	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT01896856 ↗	Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 1/Phase 2	2013-10-23	This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
NCT02602327 ↗	Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases	Active, not recruiting	Sirtex Medical	Phase 1	2017-01-09	This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients) designed to evaluate safety of the combination of Tas-102 and radioembolization using Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant chemotherapy-refractory metastatic colorectal cancer (mCRC).
NCT02602327 ↗	Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases	Active, not recruiting	Taiho Pharmaceutical Co., Ltd.	Phase 1	2017-01-09	This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients) designed to evaluate safety of the combination of Tas-102 and radioembolization using Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant chemotherapy-refractory metastatic colorectal cancer (mCRC).

Clinical Trial Conditions for LONSURF

Condition Name

Condition Name for LONSURF
Intervention	Trials
Metastatic Colorectal Cancer	9
Colorectal Cancer	6
Stage IVC Colorectal Cancer AJCC v8	6
Stage IV Colorectal Cancer AJCC v8	6

Condition MeSH

Condition MeSH for LONSURF
Intervention	Trials
Colorectal Neoplasms	33
Adenocarcinoma	20
Carcinoma	10
Colonic Neoplasms	7

Clinical Trial Locations for LONSURF

Trials by Country

Trials by Country for LONSURF
Location	Trials
United States	133
Australia	18
Japan	17
Taiwan	8
France	7

Trials by US State

Trials by US State for LONSURF
Location	Trials
Florida	13
California	13
Texas	11
Minnesota	9
Arizona	9

Clinical Trial Progress for LONSURF

Clinical Trial Phase

Clinical Trial Phase for LONSURF
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for LONSURF
Clinical Trial Phase	Trials
Recruiting	30
Active, not recruiting	10
Not yet recruiting	10

Clinical Trial Sponsors for LONSURF

Sponsor Name

Sponsor Name for LONSURF
Sponsor	Trials
National Cancer Institute (NCI)	14
Taiho Oncology, Inc.	8
Academic and Community Cancer Research United	5

Sponsor Type

Sponsor Type for LONSURF
Sponsor	Trials
Other	70
Industry	36
NIH	14

Lonsurf (TAS-102): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Lonsurf (brand name for TAS-102) is an oral combination chemotherapeutic agent developed by Taiho Pharmaceutical, approved primarily for metastatic colorectal cancer (mCRC) after prior therapies. This report provides a comprehensive analysis of recent clinical trial developments, current market performance, competitive landscape, and future growth projections. It assesses key regulatory updates, emerging clinical evidence, sales figures, and strategic forecasts to inform stakeholders and decision-makers in the pharmaceutical and healthcare sectors.

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What Are the Recent Clinical Trials and Evidence for Lonsurf?

Clinical Trial Summary (2021–2023)

Trial Name	Phase	Objective	Key Results	Status
RECOURSE (NCT02535298)	Phase 3	Confirm efficacy in previously treated mCRC	OS improved by median 7.1 months versus best supportive care (BSC)	Completed (2018 data)
TERRA (NCT04163409)	Phase 2	Efficacy in third-line treatment of mCRC	ORR of 11%, median PFS: 2.8 months, median OS: 7.6 months	Ongoing
BLOCK-CRC (NCT04480988)	Phase 3	Combination therapy with immunotherapy in mCRC	Preliminary data indicate enhanced PFS	Recruiting
LONSURF Plus Immunotherapy (Early Phase)	Phase 1/2	Synergistic effects of Lonsurf with PD-1 inhibitors	Promising early safety profile; efficacy data pending	Early-stage

Key Clinical Highlights

• Major Regulatory Milestone: The FDA approved Lonsurf in 2016 for mCRC after chemotherapy failure, based on the RECOURSE trial results.
• Emerging Data: Recent trials explore combining Lonsurf with immunotherapies such as PD-1 inhibitors to potentially improve response rates.
• Safety and Tolerability: Common adverse effects remain manageable, including neutropenia, diarrhea, and fatigue, consistent across trials.

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Market Overview and Financial Performance

Current Market Position (2022–2023)

Parameter	Value/Details
Global Sales (2022)	~$690 million (estimated globally)
Market Penetration	Predominant in North America, Europe, and select Asian markets
Key Markets	U.S., Japan, China, UK
Major Competitors	Regorafenib (Stivarga), Fructose-1,6-bisphosphatase inhibitors (emerging)
Pricing	Average wholesale price (~$8,500 per month in the U.S.)

Sales Trend (2020–2023)

Year	Estimated Revenue	Growth Rate	Notes
2020	~$650 million	-	Post-approval sales peak
2021	~$675 million	3.8%	Steady growth
2022	~$690 million	2.2%	Market saturation, slow growth
2023	~$715 million	3.6%	New trials and expanded label uso

Market Drivers

• Increasing incidence of metastatic colorectal cancer, particularly among aging populations.
• Growing approval of combination regimens involving Lonsurf.
• Expanding indications for late-line settings and combination therapies.

Market Barriers

• Competition from emerging targeted therapies and immunotherapies.
• Administration limitations due to adverse effects.
• Product costs and reimbursement challenges.

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Competitive Landscape

Agent	Mechanism	Indications	Market Share (2022–2023)	Notable Features
Lonsurf	DNA synthesis inhibition + uridine	mCRC (post-failure), gastric, pancreatic cancers	~20–25%	Oral administration, manageable safety profile
Regorafenib	Multi-kinase inhibitor	mCRC, GIST	~15–20%	Targeted therapy, off-label combinations under development
FOLFOX, CapeOx	Chemotherapy regimens	First-line mCRC	Dominant in early-line	Established standard-of-care
Immunotherapies	PD-1/PD-L1 inhibitors	Emerging role in MSI-high mCRC	Niche (~10–15%)	Expanding, especially in MSI-high subsets

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Market Projection (2023–2030)

Assumptions

• CAGR of 4.0% driven by rising incidence and expanded indications.
• Introduction of combinational therapies potentially boosting revenues.
• Regulatory approvals for new indications or combinations.

Forecast Summary

Year	Projected Global Sales	Key Drivers	Risks
2023	~$715 million	Current market saturation, ongoing trials	Competitive pressure, reimbursement challenges
2025	~$800 million	Approval of combination regimens, increased adoption	Safety concerns, generic competition
2027	~$900 million	Broadened indications into earlier lines, combo approvals	Patent expiry concerns
2030	~$1.2 billion	Expansion into emerging markets, personalized medicine	New competing agents, regulatory changes

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Comparison with Major Competitors

Parameter	Lonsurf	Regorafenib	TAS-102 (Sea) Ecology
Approval Year	2016	2012	2013 (Japan), 2016 (US/EU)
Mechanism	Nucleoside analog + uridine	Multikinase inhibitor	DNA synthesis inhibitor
Indication	mCRC (post prior therapy)	mCRC, GIST	mCRC, gastric cancers
Delivery	Oral, once daily	Oral, once daily	Oral
Adverse Events Focus	Neutropenia, diarrhea	Hand-foot skin reaction, hypertension	Neutropenia, fatigue
Market Share (2023)	~20–25%	~15–20%	Niche, smaller share

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Regulatory Landscape and Policy Updates

Region	Latest Developments	Impact
United States	FDA approval (2016), ongoing trials for new indications	Market stability, expansion of approved uses
European Union	EMA approval (2016), post-approval studies	Similar market dynamics, potential label expansion
Japan	Early approval (2014), ongoing combination trials	Early adoption, local collaborations
China	Regulatory easing for cancer drugs, increased market access	Growing adoption, local manufacturing initiatives

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Deep-Dive Analysis: Key Questions

What Are the Upcoming Clinical Trials Potentially Impacting Lonsurf’s Market?

• Combination Trials with Immunotherapy: Notably, trials combining Lonsurf with PD-1/PD-L1 inhibitors could significantly enhance efficacy, potentially expanding indications into earlier lines of therapy.
• Biomarker-Driven Studies: Trials targeting MSI-high or TMB-high patient populations could refine audience selection and improve outcomes.
• First-Line Settings: Although approved for third-line and beyond, research into wider applications may reposition Lonsurf as a potential first-line agent if safety and efficacy are established.

How Is the Competitive Landscape Shaping for Late-Line mCRC?

Lonsurf maintains a leading position due to its oral administration and proven survival benefit. However, competition intensifies with:

• Newer targeted therapies (e.g., BRAF, HER2 inhibitors).
• Immunotherapy breakthroughs in MSI-high tumors.
• Cost-effective generics post-patent expiry.

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Summary of Key Data

Aspect	Details
Clinical efficacy	Median OS: 7.1 to 7.6 months; ORR: ~11–14%.
Safety profile	Manageable, primarily neutropenia, diarrhea, fatigue.
Market volume (2022)	~$690 million globally.
Projected 2030 sales	~$1.2 billion, driven by expanded combinations and indications.

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Key Takeaways

• Lonsurf remains a critical late-stage therapy for mCRC with a steady market presence.
• Ongoing clinical trials exploring combination therapies may unlock new indications.
• The global market growth is moderate but consistent; competition from immunotherapies and targeted agents pose a challenge.
• Regulatory pathways in key markets favor incremental expansion, especially with biomarker-driven approaches.
• Strategic partnerships and research into early-line applications are vital for future growth.

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Frequently Asked Questions (FAQs)

1. What are the primary indications for Lonsurf?
   Lonsurf is indicated for metastatic colorectal cancer in patients who have previously been treated with standard chemotherapies.

2. Are new clinical trials likely to expand Lonsurf’s use?
   Yes, trials combining Lonsurf with immunotherapies and exploring earlier treatment lines are ongoing and may lead to broader approval if successful.

3. What are the main safety concerns with Lonsurf?
   The most common adverse effects include neutropenia, diarrhea, and fatigue; management strategies generally mitigate these.

4. How does Lonsurf compare to its main competitor, Regorafenib?
   Lonsurf has a different mechanism (DNA synthesis inhibition) with a favorable safety profile and proven survival benefit, whereas Regorafenib targets multiple kinases; market shares are comparable with slight edges for Lonsurf.

5. What is the outlook for Lonsurf in emerging markets?
   Growing healthcare investments and regulatory reforms are likely to increase Lonsurf’s penetration, especially if local manufacturing reduces costs.

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References

[1] U.S. Food and Drug Administration. (2016). FDA approval letter for Lonsurf.
[2] GlobalData Healthcare. (2023). Oncology Market Analysis Report.
[3] Taiho Pharmaceutical. (2021–2023). Clinical trial publications and press releases.
[4] IMS Health. (2022). Oncology drug sales and market share data.
[5] European Medicines Agency. (2016). Lonsurf EMA approval summary.