CLINICAL TRIALS PROFILE FOR TAFINLAR

All Clinical Trials for TAFINLAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02143050 ↗	Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients	Recruiting	James Graham Brown Cancer Center	Phase 1/Phase 2	2014-09-01	The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
NCT02143050 ↗	Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients	Recruiting	University of Louisville	Phase 1/Phase 2	2014-09-01	The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
NCT01947023 ↗	Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-08-29	This phase I trial studies the side effects and best dose of lapatinib when given together with dabrafenib in treating patients with thyroid cancer that cannot be removed by surgery and has not responded to previous treatment (refractory). Dabrafenib and lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01940809 ↗	Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-08-28	This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating melanoma.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	GlaxoSmithKline	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	Novartis Pharmaceuticals	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.
NCT01902173 ↗	Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2013-07-19	This phase I/II trial studies the side effects and the best dose of uprosertib when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer. Uprosertib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving uprosertib with dabrafenib and trametinib may be a better treatment for cancer.

Clinical Trial Conditions for TAFINLAR

Condition Name

Condition Name for TAFINLAR
Intervention	Trials
Melanoma	13
Metastatic Melanoma	7
Stage IIIC Cutaneous Melanoma AJCC v7	6
Stage IV Cutaneous Melanoma AJCC v6 and v7	5

Condition MeSH

Condition MeSH for TAFINLAR
Intervention	Trials
Melanoma	22
Skin Neoplasms	9
Neoplasms	8
Glioma	4

Clinical Trial Locations for TAFINLAR

Trials by Country

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−

Trials by Country for TAFINLAR
Location	Trials
United States	234
Australia	7
Germany	5
United Kingdom	3
Belgium	2

Trials by US State

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−

Trials by US State for TAFINLAR
Location	Trials
Massachusetts	11
Texas	10
Pennsylvania	8
California	8
Arizona	7

Clinical Trial Progress for TAFINLAR

Clinical Trial Phase

Clinical Trial Phase for TAFINLAR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	18

Clinical Trial Status

Clinical Trial Status for TAFINLAR
Clinical Trial Phase	Trials
Recruiting	15
Active, not recruiting	12
Completed	2

Clinical Trial Sponsors for TAFINLAR

Sponsor Name

Sponsor Name for TAFINLAR
Sponsor	Trials
National Cancer Institute (NCI)	15
Novartis	5
Novartis Pharmaceuticals	4

Sponsor Type

Sponsor Type for TAFINLAR
Sponsor	Trials
Other	42
Industry	31
NIH	15

Tafinlar: Clinical Trials, Market Analysis, and Projections

Introduction to Tafinlar

Tafinlar, also known as dabrafenib, is a BRAF inhibitor developed by Novartis. It is often used in combination with trametinib (Mekinist), a MEK inhibitor, to treat various types of cancers, particularly those with BRAF V600 mutations.

Clinical Trials and Efficacy

Recent FDA Approval

On June 22, 2022, the FDA accelerated the approval of the combination of dabrafenib and trametinib for the treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in adults and pediatric patients aged ≥6 years who have had disease progression after previous treatment[1].

Key Clinical Trials

• ROAR Study: This phase 2 study was an open-label, single-arm, multicenter trial that included patients with BRAF V600E-positive solid tumors. The study demonstrated an overall response rate (ORR) of up to 80% in patients with BRAF V600E solid tumors, with the highest responses seen in biliary tract cancer (46%) and low- and high-grade gliomas (50% and 33%, respectively)[1].
• NCI-MATCH Study: This precision medicine clinical trial included adults with BRAF V600E-positive solid tumors, excluding melanoma, thyroid cancer, and colorectal cancer. The study further validated the efficacy of the combination in various tumor types[1].
• Study X2101: This study focused on pediatric patients with BRAF V600 refractory or recurrent low- or high-grade glioma, showing an ORR of 25% and a duration of response of ≥6 months in 78% of patients, and ≥24 months in 44% of patients[1].

Clinical Outcomes

The combination of Tafinlar and Mekinist has shown significant clinical benefit across multiple studies. For example, in the clinical trials involving 131 adults, 54 (41%) patients had an objective response. In pediatric patients, the ORR was 25%, with a notable duration of response[1][4].

Adverse Reactions

The most common adverse reactions seen in adults treated with the combination include pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema. In pediatric patients, similar adverse reactions were observed, with additional common reactions including dry skin, dermatitis acneiform, and paronychia[1].

Market Analysis and Projections

Non-Small Cell Lung Cancer (NSCLC) Market

In the context of NSCLC, targeted therapies like Tafinlar and Mekinist are expected to contribute significantly to market growth. By 2025, the global NSCLC market is projected to reach $26.8 billion, with targeted therapies accounting for $9.4 billion of this total. The sales of Tafinlar and Mekinist in the NSCLC segment are expected to grow, although specific figures for these drugs in this market are not as prominent as those for other targeted therapies like Tagrisso and Avastin[2].

Melanoma Market

The melanoma market, where Tafinlar and Mekinist are also key players, is expected to grow substantially. By 2034, the melanoma market is projected to reach $8.9 billion, up from $3.9 billion in 2023. The ongoing advancements in screening techniques and combination therapies, such as the combination of Tafinlar, Mekinist, and spartalizumab, are driving this growth[5].

Sales Projections

While specific sales projections for Tafinlar alone are not detailed in the recent sources, the combination of Tafinlar and Mekinist is expected to see significant sales growth. For instance, in the broader context of targeted therapies in NSCLC, the sales of these drugs are anticipated to be substantial, though they will be part of a larger market dominated by other targeted therapies and immunotherapies[2].

Market Drivers and Challenges

Drivers of Growth

• Immunotherapies and Targeted Therapies: The increasing use of premium-priced immune checkpoint inhibitors and targeted therapies, such as Tafinlar and Mekinist, is a major driver of growth in the NSCLC and melanoma markets[2].
• Combination Therapies: The development of combination therapies, such as the triple combination of Tafinlar, Mekinist, and spartalizumab, is enhancing treatment outcomes and driving market growth[5].

Challenges

• Patent Expirations: The expiration of patents for several blockbuster drugs, including Tarceva and Alimta, will limit growth in the NSCLC market. However, this does not directly impact Tafinlar and Mekinist, which are protected by their own patents[2].
• Biosimilar Competition: The emergence of biosimilars, such as biosimilar bevacizumab, could erode the market share of branded drugs like Avastin, but this is less likely to affect Tafinlar and Mekinist directly[2].

Key Takeaways

• Clinical Efficacy: Tafinlar in combination with Mekinist has demonstrated significant efficacy in treating various solid tumors with BRAF V600 mutations.
• Market Growth: The market for targeted therapies, including Tafinlar and Mekinist, is expected to grow substantially in both the NSCLC and melanoma markets.
• Combination Therapies: The development of combination therapies involving Tafinlar and Mekinist is a key driver of market growth and improved treatment outcomes.
• Adverse Reactions: While the combination is effective, it comes with a range of adverse reactions that need to be managed.

FAQs

What is Tafinlar used for?

Tafinlar (dabrafenib) is used in combination with Mekinist (trametinib) to treat unresectable or metastatic solid tumors with a BRAF V600E mutation in adults and pediatric patients aged ≥6 years.

What are the key clinical trials for Tafinlar and Mekinist?

Key clinical trials include the ROAR study, NCI-MATCH study, and Study X2101, which have demonstrated the efficacy of the combination in various tumor types.

What is the projected market size for NSCLC by 2025?

The global NSCLC market is projected to reach $26.8 billion by 2025, with targeted therapies accounting for a significant portion of this total.

How does the combination of Tafinlar and Mekinist impact the melanoma market?

The combination, along with other advancements, is expected to drive the melanoma market to reach $8.9 billion by 2034.

What are the common adverse reactions associated with Tafinlar and Mekinist?

Common adverse reactions include pyrexia, fatigue, nausea, rash, chills, headache, and others, which vary slightly between adult and pediatric patients.

Sources

1. JHOP Online: "Tafinlar plus Mekinist First Tumor Agnostic Therapy Approved for Any Unresectable or Metastatic Solid Tumors with BRAF Mutation"[1].
2. Drug Development: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025"[2].
3. Health Canada: "Summary Basis of Decision for Tafinlar"[3].
4. Novartis: "Clinical Trial Results | TAFINLAR + MEKINIST for BRAF V600E Metastatic NSCLC"[4].
5. BioSpace: "Melanoma Market to Reach USD 8.9 Billion by 2034 Impelled by the Ongoing Advancements in Screening Techniques"[5].