CLINICAL TRIALS PROFILE FOR LONSURF

All Clinical Trials for LONSURF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
NCT02602327 ↗	Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases	Active, not recruiting	University of California, San Francisco	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).
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).

Clinical Trial Conditions for LONSURF

Condition Name

Condition Name for LONSURF
Intervention	Trials
Stage IV Colorectal Cancer AJCC v8	6
Stage IVB Colorectal Cancer AJCC v8	6
Stage IVA Colorectal Cancer AJCC v8	6
Metastatic Colorectal Cancer	6

Condition MeSH

Condition MeSH for LONSURF
Intervention	Trials
Colorectal Neoplasms	29
Adenocarcinoma	20
Carcinoma	10
Colonic Neoplasms	7

Clinical Trial Locations for LONSURF

Trials by Country

+

−

Trials by Country for LONSURF
Location	Trials
United States	112
Australia	13
Japan	12
France	6
Canada	6

Trials by US State

+

−

Trials by US State for LONSURF
Location	Trials
California	12
Florida	11
Texas	9
Minnesota	9
Arizona	9

Clinical Trial Progress for LONSURF

Clinical Trial Phase

Clinical Trial Phase for LONSURF
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	30

Clinical Trial Status

Clinical Trial Status for LONSURF
Clinical Trial Phase	Trials
Recruiting	26
Not yet recruiting	10
Active, not 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	63
Industry	32
NIH	14

Lonsurf: Clinical Trials, Market Analysis, and Projections

Introduction to Lonsurf

Lonsurf, a combination of trifluridine and tipiracil, is an antineoplastic agent used in the treatment of various advanced cancers, particularly metastatic colorectal cancer (mCRC) and gastric or gastroesophageal junction (GEJ) adenocarcinoma. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

RECOURSE Trial

The pivotal clinical trial for Lonsurf, known as the RECOURSE trial, was a Phase III, international, randomized, double-blind, placebo-controlled study. This trial involved 800 patients with mCRC who had received at least two prior regimens of standard therapies. Patients were randomized in a 2:1 ratio to receive either Lonsurf plus best supportive care (BSC) or placebo plus BSC. The results showed a statistically significant improvement in both overall survival (OS) and progression-free survival (PFS) for patients treated with Lonsurf compared to those receiving the placebo[3][4].

TAGS Trial

For the indication of GEJ adenocarcinoma, the TAGS trial was conducted. This was a multinational, double-blind, randomized, placebo-controlled Phase III trial involving 507 patients with non-resectable, metastatic gastric adenocarcinoma. Patients received either Lonsurf plus BSC or placebo plus BSC. The trial demonstrated significant improvements in OS and PFS for the Lonsurf-treated group[4].

SUNLIGHT Trial

The SUNLIGHT trial was a Phase III, multinational, randomized, active-controlled, open-label study that compared Lonsurf monotherapy with Lonsurf plus bevacizumab in patients with mCRC. The trial enrolled 492 patients and showed that the combination of Lonsurf and bevacizumab resulted in a median OS of 10.8 months, significantly better than the 7.5 months observed with Lonsurf alone[4].

Ongoing Clinical Trials: Lonsurf and Talazoparib

A recent and ongoing clinical trial is investigating the combination of Lonsurf and the PARP inhibitor talazoparib in patients with advanced colorectal or gastroesophageal cancer, particularly those with TP53 mutations. Preliminary lab experiments have shown a synergistic effect of this combination, leading to increased cancer cell death and reduced tumor growth without significant side effects. This trial aims to find the optimal dose and evaluate the side effects of this combination, with potential expansion to include patients with TP53-mutant pancreatic and breast cancer[1].

Market Analysis

Current Market Value

The global colorectal cancer drugs market, within which Lonsurf is a significant player, is valued at approximately USD 10.23 billion in 2023. This market is projected to grow to USD 12.79 billion by 2028, with a compound annual growth rate (CAGR) of 4.57%[2].

Market Dynamics

The growth in the colorectal cancer drugs market is driven by the increasing incidence of colorectal cancer, advancements in oncology pharmaceuticals, and the approval of new treatments. The market is competitive, with key players focusing on product development, market penetration, and strategic alliances. The Ansoff Matrix and SWOT analysis are used to guide market strategies, helping stakeholders navigate opportunities and challenges[2].

Regulatory Approvals

Lonsurf has received regulatory approvals in several regions. It was approved by the US FDA in September 2014 for mCRC, in Japan in March 2014 for recurrent colorectal cancer, and in 2019 for the treatment of advanced gastric or GEJ adenocarcinoma. In August 2023, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for patients with mCRC who had received prior treatments[4].

Market Projections

Growth Trajectory

The projected growth of the colorectal cancer drugs market indicates a steady increase in demand for effective treatments. Lonsurf, with its proven efficacy in mCRC and GEJ adenocarcinoma, is well-positioned to capture a significant share of this growing market. The combination of Lonsurf with other agents, such as bevacizumab and talazoparib, further enhances its market potential[2].

Competitive Landscape

The market for colorectal cancer drugs is highly competitive, with several key players vying for market share. Lonsurf's unique mechanism of action and its synergistic effects when combined with other drugs make it a competitive offering. The ongoing clinical trials and potential expansions into new indications will likely strengthen its market position[2].

Economic Impact

The economic assessment of Lonsurf, particularly when combined with bevacizumab, indicates that while it provides a clinically meaningful improvement in OS and PFS, it also comes with a significant cost. The estimated cost of Lonsurf plus bevacizumab for public drug plans over the next three years is approximately $111 million. However, price reductions are often required to make the treatment more affordable for healthcare systems[5].

Key Takeaways

• Clinical Efficacy: Lonsurf has demonstrated significant improvements in OS and PFS in clinical trials for mCRC and GEJ adenocarcinoma.
• Market Growth: The global colorectal cancer drugs market is projected to grow to USD 12.79 billion by 2028, driven by advancements in oncology and increasing demand.
• Regulatory Approvals: Lonsurf has received approvals in multiple regions for various indications, including mCRC and GEJ adenocarcinoma.
• Combination Therapies: Ongoing trials exploring the combination of Lonsurf with talazoparib and bevacizumab show promising results, potentially expanding its therapeutic applications.
• Economic Considerations: While Lonsurf offers clinical benefits, its cost is a significant factor, necessitating price reductions to ensure affordability for healthcare systems.

FAQs

What is Lonsurf used for?

Lonsurf is used for the treatment of metastatic colorectal cancer (mCRC) and gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received prior treatments.

What are the key findings from the RECOURSE trial?

The RECOURSE trial showed statistically significant improvements in overall survival (OS) and progression-free survival (PFS) for patients treated with Lonsurf compared to those receiving a placebo.

What is the current market value of the global colorectal cancer drugs market?

The global colorectal cancer drugs market is valued at approximately USD 10.23 billion in 2023.

What is the projected growth rate of the global colorectal cancer drugs market?

The market is projected to grow at a compound annual growth rate (CAGR) of 4.57% to reach USD 12.79 billion by 2028.

What are the common side effects of Lonsurf?

Common side effects include anaemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhoea, vomiting, abdominal pain, and pyrexia.

Sources

1. NCI: Lonsurf and Talzenna for Cancers with TP53 Mutations - NCI
2. GlobeNewswire: Global Colorectal Cancer Drugs Market to Reach USD 12.79 Billion by 2028 with Notable CAGR of 4.57%
3. Health Canada: Summary Basis of Decision for Lonsurf
4. Clinical Trials Arena: Lonsurf (trifluridine and tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer
5. NCBI Bookshelf: Trifluridine-Tipiracil (Lonsurf)