CLINICAL TRIALS PROFILE FOR MEKTOVI

All Clinical Trials for MEKTOVI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02902042 ↗	Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma	Completed	Prof. Dr. med. Dirk Schadendorf	Phase 1/Phase 2	2018-04-24	This study will investigate the influence of maintenance therapy on progression-free survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase) inhibitors and PD-1 antibody pembrolizumab. In the safety phase I part the optimal dose of pembrolizumab in combination with BRAF inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be determined. In the randomized part 2 different maintenance therapies will be tested for toxicity and efficacy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on, either continuation of triple therapy or administration of pembrolizumab alone.
NCT03106415 ↗	Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2017-09-26	This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it works when given together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with triple negative breast cancer.
NCT02910700 ↗	Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma	Recruiting	Bristol-Myers Squibb	Phase 2	2016-12-09	This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
NCT02910700 ↗	Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2016-12-09	This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
NCT02910700 ↗	Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma	Recruiting	M.D. Anderson Cancer Center	Phase 2	2016-12-09	This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
NCT02465060 ↗	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Recruiting	National Cancer Institute (NCI)	Phase 2	2015-08-12	This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Clinical Trial Conditions for MEKTOVI

Condition Name

Condition Name for MEKTOVI
Intervention	Trials
Melanoma	7
Metastatic Melanoma	7
Advanced Malignant Solid Neoplasm	4
Malignant Melanoma	3

Condition MeSH

Condition MeSH for MEKTOVI
Intervention	Trials
Melanoma	18
Neoplasms	8
Carcinoma	7
Skin Neoplasms	6

Clinical Trial Locations for MEKTOVI

Trials by Country

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Trials by Country for MEKTOVI
Location	Trials
United States	149
Germany	19
Spain	13
Italy	7
United Kingdom	6

Trials by US State

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Trials by US State for MEKTOVI
Location	Trials
Texas	11
California	10
Massachusetts	8
Florida	8
New York	6

Clinical Trial Progress for MEKTOVI

Clinical Trial Phase

Clinical Trial Phase for MEKTOVI
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	19
Phase 1/Phase 2	7

Clinical Trial Status

Clinical Trial Status for MEKTOVI
Clinical Trial Phase	Trials
Recruiting	17
Not yet recruiting	12
Active, not recruiting	4

Clinical Trial Sponsors for MEKTOVI

Sponsor Name

Sponsor Name for MEKTOVI
Sponsor	Trials
National Cancer Institute (NCI)	16
Pierre Fabre Medicament	5
Pfizer	5

Sponsor Type

Sponsor Type for MEKTOVI
Sponsor	Trials
Other	33
Industry	29
NIH	16

Clinical Trials, Market Analysis, and Projections for MEKTOVI

Introduction to MEKTOVI

MEKTOVI, also known as binimetinib, is a MEK inhibitor used in the treatment of certain types of cancer, particularly those with BRAF V600E or V600K mutations. Here, we will delve into the clinical trials that led to its approval, the current market analysis, and future projections for this drug.

Clinical Trials for MEKTOVI

Trial Design and Outcomes

The clinical efficacy and safety of MEKTOVI were established through a pivotal Phase III, randomized, active-controlled, open-label study known as the COLUMBUS trial. This trial involved patients with unresectable or metastatic melanoma who had BRAF V600E or V600K mutations[1][3].

• Treatment Arms: Patients were randomized to receive either MEKTOVI (45 mg twice daily) in combination with encorafenib (450 mg once daily), encorafenib alone (300 mg once daily), or vemurafenib (960 mg twice daily).
• Primary Efficacy Endpoint: The primary endpoint was progression-free survival (PFS) as assessed by a blinded independent central review. The results showed a statistically and clinically significant improvement in PFS for patients treated with the combination of MEKTOVI and encorafenib compared to those treated with vemurafenib. The median PFS was 14.9 months for the MEKTOVI and encorafenib combination versus 7.3 months for vemurafenib[1][3].

Additional Efficacy Measures

• Overall Survival, Objective Response Rate, and Duration of Response: These secondary endpoints also supported the clinical benefit of the MEKTOVI and encorafenib combination. The study demonstrated improved overall survival, a higher objective response rate, and a longer duration of response compared to vemurafenib[3].

Safety Profile

• Adverse Events: The safety profile of MEKTOVI in combination with encorafenib was consistent with previous findings. Common treatment-related adverse events included nausea, diarrhea, and fatigue. More severe adverse events such as new primary malignancies, uveitis, hemorrhages, hepatotoxicity, cardiomyopathy, and embryo-fetal toxicity were also observed[4].

Market Analysis for MEKTOVI

Global MEK Inhibitors Market

The global MEK inhibitors market, which includes MEKTOVI, is projected to grow significantly. Here are some key points:

• Market Size: The global MEK inhibitors market is expected to surpass $3 billion by 2026, driven by factors such as the rising geriatric population, increased focus on research and development, and a large number of ongoing clinical trials[2].
• Competitive Landscape: The market is highly consolidated with major players including AstraZeneca, Bristol Myers Squibb, Pfizer, Roche, and SpringWorks Therapeutics. These companies are actively involved in the development of new MEK inhibitors and combinations[2][5].

Sales and Market Share

• Approved Drugs: MEKTOVI is one of the four approved MEK inhibitors in the market, along with trametinib, selumetinib, and cobimetinib. The sales data for these drugs indicate a strong market presence, with MEKINIST (trametinib) having a significant share in 2018[5].
• Geographic Segmentation: The market is segmented geographically, with North America, Europe, and Asia being key regions. Each region has its own market size and forecast, with North America and Europe leading in terms of market share[5].

Future Projections for MEKTOVI

Ongoing Clinical Trials and Expanding Indications

• New Therapeutic Indications: MEKTOVI is being evaluated in various ongoing clinical trials for other therapeutic indications, including thyroid, breast, pancreatic, colorectal, and non-small cell lung cancer. For instance, the PHAROS trial demonstrated sustained efficacy of the combination of Braftovi (encorafenib) and MEKTOVI in patients with BRAF V600E-mutant metastatic non-small cell lung cancer[4].
• Potential New Standard of Care: Recent trials have shown that MEK inhibitors, such as trametinib, could become the new standard of care for certain patient populations, such as those with relapsed or persistent low-grade serous ovarian carcinoma. This trend is expected to continue, driving the growth of the MEK inhibitors market[2].

Pipeline Development

• New Candidates: Several new MEK inhibitors are in the developmental pipeline, including NFX-179, CS3006, HL085, Pimacertib, and Mirdametinib. These drugs have shown promising results in clinical trials, both as monotherapy and in combination therapy, and are mostly in Phase I/II clinical trials[2].

Key Takeaways

• Clinical Efficacy: MEKTOVI, in combination with encorafenib, has demonstrated significant clinical benefits in patients with BRAF V600E or V600K mutation-positive melanoma.
• Market Growth: The global MEK inhibitors market is expected to surpass $3 billion by 2026, driven by increasing demand and ongoing clinical trials.
• Expanding Indications: MEKTOVI is being evaluated for various new therapeutic indications, which could further expand its market presence.
• Pipeline Development: New MEK inhibitors in the developmental pipeline are expected to enter the market, contributing to the growth of the MEK inhibitors segment.

FAQs

What is MEKTOVI used for?

MEKTOVI (binimetinib) is used in the treatment of certain types of cancer, particularly those with BRAF V600E or V600K mutations, such as unresectable or metastatic melanoma.

What were the key findings of the COLUMBUS trial?

The COLUMBUS trial showed a statistically and clinically significant improvement in progression-free survival for patients treated with MEKTOVI and encorafenib compared to those treated with vemurafenib.

What is the projected market size for MEK inhibitors by 2026?

The global MEK inhibitors market is expected to surpass $3 billion by 2026.

Which companies are major players in the MEK inhibitors market?

Major players include AstraZeneca, Bristol Myers Squibb, Pfizer, Roche, and SpringWorks Therapeutics.

What new therapeutic indications are being explored for MEKTOVI?

MEKTOVI is being evaluated for various new therapeutic indications, including thyroid, breast, pancreatic, colorectal, and non-small cell lung cancer.

References

1. FDA: Drug Trial Snapshot: MEKTOVI - FDA.
2. Biospace: MEK Inhibitors Clinical Development Market Approval Insight 2026.
3. Health Canada: Summary Basis of Decision for Mektovi.
4. Pharm Exec: Braftovi Plus Mektovi Demonstrates Sustained Efficacy in Patients ...
5. GlobeNewswire: MEK Inhibitors: Worldwide Markets to 2023 with Sales Data.