CLINICAL TRIALS PROFILE FOR TASIGNA

All Clinical Trials for tasigna

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00644878 ↗	Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib	Terminated	Novartis Pharmaceuticals	Phase 2	2008-10-01	This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib
NCT00702403 ↗	Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2008-08-14	This phase I/II trial is studying the side effects and best way to give nilotinib when given alone or sequentially after imatinib mesylate after donor stem cell transplant in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Conditions for tasigna

Condition Name

Condition Name for tasigna
Intervention	Trials
Chronic Myeloid Leukemia	10
Leukemia	4
Chronic Myelogenous Leukemia, BCR-ABL1 Positive	3
Chronic Phase Chronic Myeloid Leukemia	3

Condition MeSH

Condition MeSH for tasigna
Intervention	Trials
Leukemia	33
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	32
Leukemia, Myeloid	31
Leukemia, Myeloid, Chronic-Phase	10

Clinical Trial Locations for tasigna

Trials by Country

Trials by Country for tasigna
Location	Trials
United States	165
Brazil	20
Spain	10
Germany	9
Korea, Republic of	9

Trials by US State

Trials by US State for tasigna
Location	Trials
Texas	11
California	10
New York	9
North Carolina	7
Washington	7

Clinical Trial Progress for tasigna

Clinical Trial Phase

Clinical Trial Phase for tasigna
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	10
Phase 2	34

Clinical Trial Status

Clinical Trial Status for tasigna
Clinical Trial Phase	Trials
Completed	31
Terminated	13
Recruiting	11

Clinical Trial Sponsors for tasigna

Sponsor Name

Sponsor Name for tasigna
Sponsor	Trials
Novartis Pharmaceuticals	15
Novartis	11
National Cancer Institute (NCI)	10

Sponsor Type

Sponsor Type for tasigna
Sponsor	Trials
Other	83
Industry	47
NIH	11

Tasigna Market Analysis and Financial Projection

Tasigna: Clinical Trials, Market Analysis, and Projections

Introduction to Tasigna

Tasigna, also known by its generic name nilotinib, is a targeted therapy used primarily for the treatment of Chronic Myeloid Leukemia (CML), a type of cancer that affects the blood and bone marrow. It belongs to a class of medications known as tyrosine kinase inhibitors, which work by blocking specific signals involved in the growth and spread of cancer cells.

Clinical Trials and Efficacy

ENESTnd Study

One of the pivotal clinical trials for Tasigna is the ENESTnd study, a Phase III trial conducted at 217 global sites with 846 patients enrolled. Patients were randomized to receive either Tasigna 300 mg twice daily, Tasigna 400 mg twice daily, or Gleevec 400 mg once daily. The primary endpoint was the achievement of Major Molecular Response (MMR) at 12 months, with a key secondary endpoint being durable MMR at 24 months.

• The 24-month analysis showed that Tasigna induced deeper and more durable cytogenetic and molecular responses compared to Gleevec. Specifically, MMR was achieved by 71% of patients taking Tasigna 300 mg twice daily and 67% of patients taking Tasigna 400 mg twice daily, compared to 44% of patients taking Gleevec[1].
• Fewer patients taking Tasigna progressed to advanced stages of the disease, with only 2 and 3 patients in the Tasigna 300 mg and 400 mg arms, respectively, progressing to accelerated phase or blast crisis, compared to 12 patients in the Gleevec arm[1].

Treatment-Free Remission

The FDA updated the label for Tasigna in 2017 to include information on treatment-free remission (TFR) for certain patients. This update was based on two single-arm trials that measured how long patients could stop taking Tasigna without the leukemia returning. Patients who had taken Tasigna for three or more years and met specific criteria could discontinue treatment, with regular monitoring for disease recurrence. The trials showed that a significant percentage of patients remained in TFR after one and two years[4].

Market Analysis

Global Market Size and Growth

As of 2024, the global Tasigna market size is estimated to be USD 9715.5 million, with a projected compound annual growth rate (CAGR) of 14.20% from 2024 to 2031. This growth is driven by increasing awareness and diagnosis of CML, advancements in cancer treatment protocols, and the rising incidence of CML worldwide[2].

Regional Market Share

• North America: Holds more than 40% of the global revenue, with a market size of USD 3886.20 million in 2024 and a CAGR of 12.4% from 2024 to 2031.
• Europe: Accounts for more than 30% of the global revenue, with a market size of USD 2914.65 million in 2024 and a CAGR of 12.7% from 2024 to 2031.
• Asia Pacific: Represents around 23% of the global revenue, with a market size of USD 2234.57 million in 2024 and a CAGR of 16.2% from 2024 to 2031.
• Latin America and Middle East & Africa: Hold smaller but growing market shares, with CAGRs of 13.6% and 13.9%, respectively[2].

Impact of Patent Expiry

US and EU Patent Expiry

Tasigna faces a significant sales decline due to the expiry of its US patent in January 2024, following the EU patent expiry in July 2023. This is expected to result in a 50% decrease in sales from 2023 to 2024. By the end of 2029, sales are projected to plummet from $1.8 billion in 2023 to just $79 million[3].

Market Competition and Accessibility

The entry of generic and reformulated versions of Tasigna will introduce increased competition, leading to lower prices and making the drug more accessible to a larger patient population. This shift is poised to reshape the CML drug market, fostering competition and improving patient accessibility[3].

Safety and Tolerability

Tasigna has been generally well tolerated in clinical trials. Fewer patients taking Tasigna discontinued treatment due to adverse events compared to those taking Gleevec. The drug's safety profile, combined with its efficacy, positions it as a preferred treatment option for patients with Ph+ CML[1].

Regulatory Approvals and Indications

Tasigna has been approved in more than 85 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to prior therapies, including Gleevec. The FDA granted approval in 2007, and it is included on the World Health Organization’s Model List of Essential Medicines for the treatment of adult and pediatric CML[1][3].

Key Takeaways

• Clinical Efficacy: Tasigna has shown superior efficacy in clinical trials, particularly in the ENESTnd study, by inducing deeper and more durable molecular responses compared to Gleevec.
• Market Growth: The global Tasigna market is expected to grow at a CAGR of 14.20% from 2024 to 2031, driven by increasing awareness and diagnosis of CML.
• Regional Market Share: North America, Europe, and Asia Pacific are the major regions driving the market growth.
• Patent Expiry Impact: The expiry of US and EU patents will lead to a significant decline in sales but will also increase competition and patient accessibility.
• Safety and Tolerability: Tasigna is generally well tolerated, with fewer discontinuations due to adverse events compared to Gleevec.

FAQs

What is Tasigna used for?

Tasigna is used for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adult patients, particularly those who are resistant or intolerant to prior therapies.

How does Tasigna work?

Tasigna works by inhibiting the abnormal Bcr-Abl tyrosine kinase receptor signaling that is responsible for the proliferation of CML cells.

What are the key findings from the ENESTnd study?

The ENESTnd study showed that Tasigna induced deeper and more durable cytogenetic and molecular responses compared to Gleevec, with fewer patients progressing to advanced stages of the disease.

How will the patent expiry affect Tasigna sales?

The patent expiry is expected to result in a significant decline in sales, with a projected drop from $1.8 billion in 2023 to $79 million by the end of 2029, but it will also increase competition and patient accessibility.

Can patients stop taking Tasigna after a certain period?

Yes, certain patients with early (chronic) phase CML who have been taking Tasigna for three years or more and whose leukemia has responded to treatment according to specific criteria may be eligible to stop taking Tasigna, but they must be regularly monitored for disease recurrence.

Sources

1. Novartis Press Release: "Longer-term Phase III data show Novartis drug Tasigna continues to surpass Gleevec in slowing disease progression in patients with newly diagnosed chronic phase Ph+ CML."
2. Cognitive Market Research: "Tasigna Market Report 2024 (Global Edition)"
3. GlobalData: "Novartis blockbuster drug Tasigna faces sales decline as US patent expiry looms, observes GlobalData"
4. FDA Press Announcement: "FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response"