CLINICAL TRIALS PROFILE FOR BINIMETINIB

All Clinical Trials for Binimetinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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
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.

Clinical Trial Conditions for Binimetinib

Condition Name

Condition Name for Binimetinib
Intervention	Trials
Melanoma	14
Metastatic Melanoma	10
BRAF V600 Mutation	6
Colorectal Cancer	6

Condition MeSH

Condition MeSH for Binimetinib
Intervention	Trials
Melanoma	39
Colorectal Neoplasms	18
Carcinoma, Non-Small-Cell Lung	12
Lung Neoplasms	12

Clinical Trial Locations for Binimetinib

Trials by Country

Trials by Country for Binimetinib
Location	Trials
United States	307
Spain	45
China	38
Italy	35
Germany	30

Trials by US State

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
PHASE4	1
PHASE2	3
Phase 4	1

Clinical Trial Status

Clinical Trial Status for Binimetinib
Clinical Trial Phase	Trials
Recruiting	53
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	111
Other	102
NIH	22

Binimetinib: Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

What is binimetinib and what is its current commercial footprint?

Binimetinib (MEKTOVI) is a MEK inhibitor developed for BRAF-mutant cancers, used in combination with encorafenib. The branded product carries a US commercial footprint and has label expansions across melanoma and adjoined BRAF-driven indications depending on jurisdiction and line of therapy.

Regimen positioning (core):

• Binimetinib + encorafenib is the key marketed combination.
• Indication scope is tied to BRAF V600 mutation status and disease setting (advanced or metastatic, and combinations in approved lines).

Market coverage drivers:

• Combination therapy adoption where molecular testing identifies BRAF V600 mutations.
• Competitive pressure from other BRAF/MEK combinations (and emerging RAF/MEK or ERK-pathway strategies) that target similar molecular profiles.

Which clinical trial programs define the next cycle for binimetinib?

A full and accurate “clinical trials update” requires a complete registry pull (e.g., ClinicalTrials.gov with sponsor, status, enrollment, arms, endpoints, and results). That level of record completeness is not present in the information available in this chat, so a complete trial-by-trial status update cannot be produced here.

What efficacy endpoints anchor clinical development and label durability?

For MEK inhibitors used with RAF inhibitors, development and regulatory positioning typically emphasize:

• Overall response rate (ORR)
• Progression-free survival (PFS)
• Overall survival (OS)
• Duration of response (DoR)
• Safety and tolerability (rash, diarrhea, ocular events, cardiac effects are key class considerations)

A complete, evidence-anchored update requires trial-specific results and dates, which are not available in this chat input.

What safety and discontinuation dynamics matter for market uptake?

Class-relevant safety trends that influence treatment persistence and payer coverage include:

• Gastrointestinal toxicity (diarrhea) and supportive care requirements
• Rash/dermatologic events
• Ocular toxicity monitoring needs
• Cardiac monitoring considerations for kinase inhibitors

A market projection depends on real-world discontinuation rates, dose modifications, and adverse-event management, which require claims/registry data not provided here.

How does the competitive landscape affect pricing and share?

Binimetinib competes in molecularly selected oncology combinations targeting BRAF V600 altered tumors. Commercial outcomes depend on:

• Therapy selection by line of treatment (first-line vs subsequent-line)
• Testing penetration and sequencing strategy with other targeted regimens
• Net price and access (rebates, formulary placement)
• Tolerability profile relative to competing BRAF/MEK combinations
• Evolving standards of care as immunotherapy combinations and next-gen targeted approaches expand

A quantitative market analysis requires competitor sales, utilization share, and access terms. Those datasets are not included in the current chat context.

What is the market size for binimetinib and what are the forecast ranges?

A precise market forecast (with revenue, CAGR, and scenario ranges) requires:

• Historical net sales by geography
• Pricing and contract structure
• Forecasted patient volumes (incidence, testing rates, eligible proportions, line-of-therapy migration)
• Competitor share changes
• Risk adjustments for label expansion or erosion

None of these inputs are available in this chat, so a complete projection cannot be produced without fabricating figures.

What business scenarios should investors and commercial teams model?

A defensible scenario model requires quantitative anchors (sales base-year, patient volumes, share assumptions, and sensitivity bounds). Without registry and market baseline inputs, only the framework can be stated:

Scenario levers that typically move MEK/RAF combination forecasts:

• Uptake rate driven by molecular testing and prescriber adoption
• Access dynamics (formulary wins, payer criteria, prior authorization trends)
• Treatment duration driven by tolerability and dose intensity
• Share shift due to competitive entries and sequencing changes
• Label expansion that adds new lines or tumor settings

No numerical ranges are provided due to missing baseline data.

What are the key “watch items” for near-term outcomes?

For binimetinib, near-term commercial and clinical catalysts generally include:

• Readouts that update PFS/OS and durability in BRAF V600 populations
• Safety updates that affect dosing protocols and persistence
• Regulatory outcomes for label expansions or geographic onboarding
• Competition changes that shift sequencing strategy

A date-specific catalyst calendar cannot be produced here without trial and regulatory timelines.

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Key Takeaways

• Binimetinib is a branded MEK inhibitor used in combination therapy for BRAF V600 altered cancers; commercialization and forecast outcomes depend on BRAF testing and treatment sequencing.
• A complete “clinical trials update” and a quantitative “market analysis and projection” require trial registry details (status, arms, endpoints, readout dates) and market inputs (net sales base year, patient volumes, pricing/access, competitor share). Those data are not present in this chat, so no complete, accurate dataset-backed update or forecast can be delivered here.

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FAQs

1. What tumor type is binimetinib primarily used for?
   It is used in BRAF V600 mutation driven oncology settings, typically as a combination with encorafenib.

2. What endpoints determine clinical success for binimetinib-based combinations?
   Trials generally anchor on ORR, PFS, OS, DoR, and safety/tolerability outcomes.

3. What drives binimetinib commercial adoption?
   Molecular testing rates for BRAF V600 and prescriber preference for targeted combinations in the relevant line of therapy.

4. How does safety affect market performance?
   Adverse-event burden and monitoring requirements influence dosing continuity and persistence, which can shift real-world utilization.

5. What is the biggest uncertainty in forecasting binimetinib revenue?
   Patient volume projections, access and pricing, and competitor share shifts across lines of therapy.

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References

[1] FDA. (n.d.). Label for MEKTOVI (binimetinib). U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. (n.d.). Binimetinib studies. U.S. National Library of Medicine.
[3] EMA. (n.d.). MEKTOVI (binimetinib) product information. European Medicines Agency.