CLINICAL TRIALS PROFILE FOR BINIMETINIB

All Clinical Trials for binimetinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02041481 ↗	MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer	Completed	Array BioPharma	Phase 1	2014-06-01	This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.
NCT02041481 ↗	MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2014-06-01	This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.
NCT02041481 ↗	MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer	Completed	City of Hope Medical Center	Phase 1	2014-06-01	This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.
NCT01801358 ↗	A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma	Terminated	Array BioPharma	Phase 1/Phase 2	2013-08-01	A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
NCT01801358 ↗	A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma	Terminated	Array Biopharma, now a wholly owned subsidiary of Pfizer	Phase 1/Phase 2	2013-08-01	A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
NCT01562899 ↗	A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors	Terminated	Array BioPharma	Phase 1/Phase 2	2012-08-27	This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.
NCT01562899 ↗	A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors	Terminated	Pfizer	Phase 1/Phase 2	2012-08-27	This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.

Clinical Trial Conditions for binimetinib

Condition Name

Condition Name for binimetinib
Intervention	Trials
Melanoma	13
Metastatic Melanoma	10
BRAF V600 Mutation	6
Malignant Melanoma	5

Condition MeSH

Condition MeSH for binimetinib
Intervention	Trials
Melanoma	36
Colorectal Neoplasms	17
Carcinoma, Non-Small-Cell Lung	12
Lung Neoplasms	12

Clinical Trial Locations for binimetinib

Trials by Country

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Trials by Country for binimetinib
Location	Trials
United States	307
China	38
Italy	35
Spain	33
Germany	30

Trials by US State

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−

Trials by US State for binimetinib
Location	Trials
California	27
Texas	23
New York	16
Massachusetts	16
Florida	16

Clinical Trial Progress for binimetinib

Clinical Trial Phase

Clinical Trial Phase for binimetinib
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2	44

Clinical Trial Status

Clinical Trial Status for binimetinib
Clinical Trial Phase	Trials
Recruiting	51
Not yet recruiting	20
Active, not recruiting	10

Clinical Trial Sponsors for binimetinib

Sponsor Name

Sponsor Name for binimetinib
Sponsor	Trials
Pfizer	27
Array BioPharma	26
National Cancer Institute (NCI)	22

Sponsor Type

Sponsor Type for binimetinib
Sponsor	Trials
Industry	106
Other	95
NIH	22

Binimetinib: Clinical Trials, Market Analysis, and Projections

Introduction to Binimetinib

Binimetinib is a MEK inhibitor, a class of drugs that target the MEK protein to prevent the growth and spread of cancer cells. It is primarily used in the treatment of advanced melanoma and other cancers, often in combination with other medications.

Clinical Trials Update

PHAROS Trial for BRAF V600E-Mutant NSCLC

The PHAROS clinical trial has provided significant insights into the efficacy and safety of binimetinib in combination with encoradenib for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). After an additional 18 months of follow-up, the trial showed an objective response rate (ORR) of 75% and a median duration of response (DoR) of 40 months in treatment-naïve patients. For previously treated patients, the ORR was 46% with a median DoR of 16.7 months. The median progression-free survival (PFS) in treatment-naïve patients was 30.2 months, and the median overall survival (OS) had not yet been reached[1].

ComboMATCH Trial for RAS-Mutant Cancers

The ComboMATCH treatment trial is evaluating the effectiveness of binimetinib in combination with palbociclib for patients with RAS-mutated cancers. This phase II trial aims to determine whether this combination improves progression-free survival (PFS) and clinical outcomes in patients with low-grade serous ovarian cancer, pancreatic cancer, and other RAS-mutated cancers. The trial assesses various endpoints including PFS, overall survival (OS), duration of response (DoR), and disease control rate (DCR)[4].

Other Ongoing Trials

Several ongoing clinical trials are exploring the role of binimetinib in various cancer types. For instance, the TAPUR study showed promising results with the combination of cobimetinib (another MEK inhibitor) and vemurafenib in patients with BRAF mutations, highlighting the potential of MEK inhibitors in combination therapies[3].

Market Analysis

Market Size and Growth

The binimetinib market is expected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. The global MEK inhibitors market, which includes binimetinib, is projected to surpass $3 billion by 2026. This growth is driven by factors such as the rising geriatric population, increased focus on research and development, and a large number of ongoing clinical trials[2][3].

Regional Market Performance

• North America: This region dominates the binimetinib market with an active share, driven by advanced healthcare infrastructure and high adoption rates of targeted therapies[2].
• Europe: Europe is the second-largest region, with significant demand for binimetinib due to rising cancer incidence and supportive government initiatives[2].
• Asia Pacific: This region is expected to be the fastest-growing segment, driven by a large and expanding cancer population, particularly in China and India, along with increasing healthcare expenditure and infrastructure[2].

Key Market Players

The binimetinib market is dominated by a few large companies, including Pfizer and Alembic Pharma. These companies are actively involved in clinical trials and collaborations, which further drive market growth[2][3].

Market Projections

Future Market Assessment

The global MEK inhibitors market, including binimetinib, is expected to continue growing due to several factors:

• Increasing Cancer Incidence: The rising geriatric population and increasing incidence of cancer are major drivers.
• Research and Development: Ongoing clinical trials and the development of new MEK inhibitors are expected to expand the market.
• Government Policies: Favorable government policies and funding for life science companies also contribute to market growth[3].

Emerging Trends

• Combination Therapies: The trend towards combination therapies, such as binimetinib with encoradenib or palbociclib, is expected to dominate the market. These combinations have shown promising results in clinical trials and are likely to become standard treatment options for various cancers[1][3][4].
• Expanded Indications: Binimetinib is being evaluated for use in other therapeutic indications beyond melanoma, including NSCLC, colorectal cancer, and ovarian cancer. This expansion is expected to further boost market growth[1][3].

Safety and Tolerability

Binimetinib, when used in combination with other drugs, has shown a manageable safety profile. Common treatment-related adverse events include nausea, diarrhea, and fatigue. The safety lead-in data from the BREAKWATER study, for example, found that the combination of encoradenib, binimetinib, cetuximab, and FOLFIRI chemotherapy was generally tolerable in patients with BRAF V600E-mutant metastatic colorectal cancer[1].

Key Takeaways

• Clinical Efficacy: Binimetinib has shown long-term clinically meaningful responses in patients with BRAF V600E-mutant metastatic NSCLC and other cancers.
• Market Growth: The binimetinib market is projected to grow significantly due to increasing cancer incidence, ongoing clinical trials, and favorable government policies.
• Combination Therapies: The use of binimetinib in combination with other targeted therapies is a key trend and is expected to dominate the market.
• Safety Profile: Binimetinib has a manageable safety profile, with common adverse events being nausea, diarrhea, and fatigue.

FAQs

What is binimetinib used for?

Binimetinib is used to treat certain types of cancer, most notably advanced melanoma, and is also being investigated for use in other cancers such as NSCLC and colorectal cancer.

What are the common side effects of binimetinib?

Common treatment-related adverse events associated with binimetinib include nausea, diarrhea, and fatigue.

Which companies are major players in the binimetinib market?

The major players in the binimetinib market include Pfizer and Alembic Pharma.

What is the projected market size for binimetinib by 2034?

The global MEK inhibitors market, which includes binimetinib, is expected to surpass $3 billion by 2026 and continue growing through 2034.

Are there ongoing clinical trials for binimetinib?

Yes, there are several ongoing clinical trials evaluating the efficacy and safety of binimetinib in combination with other drugs for various cancer types.

Sources

1. ESMO 2024: Encoradenib & binimetinib shows long-term clinically meaningful response in patients with BRAF V600E-mutant metastatic non-small Cell lung cancer. ecancer.org.
2. Binimetinib Market Research Report 2024-2034. We Market Research.
3. MEK Inhibitors Clinical Development Market Approval Insight 2026. Biospace.
4. Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial. UF Health.