CLINICAL TRIALS PROFILE FOR ENCORAFENIB

All Clinical Trials for ENCORAFENIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01777776 ↗	Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.	Terminated	Array BioPharma	Phase 1/Phase 2	2013-07-01	To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
NCT01820364 ↗	LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma	Terminated	Array BioPharma	Phase 2	2013-11-01	The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
NCT02109653 ↗	Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC	Withdrawn	Array BioPharma	Phase 2	2015-06-01	This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
NCT02109653 ↗	Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC	Withdrawn	Array Biopharma, now a wholly owned subsidiary of Pfizer	Phase 2	2015-06-01	This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
NCT02263898 ↗	Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations	Withdrawn	National Cancer Institute (NCI)	Phase 2	2015-01-01	This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.
NCT02263898 ↗	Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations	Withdrawn	Jonsson Comprehensive Cancer Center	Phase 2	2015-01-01	This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.
NCT02834364 ↗	BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)	Active, not recruiting	Array BioPharma	Phase 2	2016-06-01	Trial for patients with refractory multiple myeloma after failure of at least two treatment regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162).

Clinical Trial Conditions for ENCORAFENIB

Condition Name

Condition Name for ENCORAFENIB
Intervention	Trials
Melanoma	12
Metastatic Melanoma	8
Metastatic Colorectal Cancer	7
Colorectal Cancer	6

Condition MeSH

Condition MeSH for ENCORAFENIB
Intervention	Trials
Melanoma	28
Colorectal Neoplasms	18
Neoplasms	7
Brain Neoplasms	7

Clinical Trial Locations for ENCORAFENIB

Trials by Country

Trials by Country for ENCORAFENIB
Location	Trials
United States	178
China	41
Italy	35
Spain	30
Germany	28

Trials by US State

Trials by US State for ENCORAFENIB
Location	Trials
California	15
Texas	15
Tennessee	11
New York	11
Florida	9

Clinical Trial Progress for ENCORAFENIB

Clinical Trial Phase

Clinical Trial Phase for ENCORAFENIB
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ENCORAFENIB
Clinical Trial Phase	Trials
Recruiting	37
Not yet recruiting	19
Active, not recruiting	6

Clinical Trial Sponsors for ENCORAFENIB

Sponsor Name

Sponsor Name for ENCORAFENIB
Sponsor	Trials
Pfizer	20
National Cancer Institute (NCI)	14
Array BioPharma	13

Sponsor Type

Sponsor Type for ENCORAFENIB
Sponsor	Trials
Industry	81
Other	54
NIH	14

ENCORAFENIB Market Analysis and Financial Projection

Encorafenib: Clinical Trials, Market Analysis, and Projections

Introduction to Encorafenib

Encorafenib, marketed as BRAFTOVI, is a BRAF kinase inhibitor that has shown significant promise in the treatment of various cancers, particularly those with BRAF V600E or V600K mutations. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

COLUMBUS Trial

One of the most notable clinical trials involving encorafenib is the COLUMBUS trial, a randomized, open-label, phase III study. This trial compared the efficacy of encorafenib plus binimetinib versus vemurafenib in patients with BRAF V600E/K-mutant metastatic melanoma.

• Patient Population: The trial included 577 patients who were treatment-naive or had progressed after first-line immunotherapy. Patients were randomized to receive either encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, vemurafenib 960 mg twice daily, or encorafenib monotherapy 300 mg once daily[1][4].
• Outcomes: The 7-year analysis showed that the combination of encorafenib and binimetinib resulted in significantly improved progression-free survival (PFS) and overall survival (OS) compared to vemurafenib. The PFS and OS rates at 7 years were 21.2% and 27.4%, respectively, in the encorafenib plus binimetinib arm, versus 6.4% and 18.2% in the vemurafenib arm[1][4].

Combination with Immunotherapy

Another significant trial examined the use of encorafenib and binimetinib as induction therapy before nivolumab and ipilimumab in patients with BRAF V600E/K-mutant metastatic melanoma.

• Design: Patients were randomly assigned to receive either encorafenib plus binimetinib for 12 weeks followed by nivolumab and ipilimumab, or nivolumab and ipilimumab alone. After disease progression, patients in the experimental arm could receive encorafenib plus binimetinib again[3].
• Outcomes: While the trial did not show a significant improvement in PFS with the addition of encorafenib and binimetinib as induction therapy, it highlighted the safety profile and the potential for long-term responders. The 2-year overall survival rates were 68% for the encorafenib/binimetinib induction group and 74% for the nivolumab/ipilimumab group[3].

Approval in Non-Small Cell Lung Cancer (NSCLC)

Encorafenib plus binimetinib has recently been approved by the European Commission for use in adult patients with advanced NSCLC harboring a BRAF V600E mutation.

• PHAROS Study: This open-label, single-arm, multicenter phase 2 study included patients with BRAF V600E-mutated NSCLC. The study showed an objective response rate (ORR) of 46% with 10% of responders achieving complete responses. The median duration of response was 16.7 months[5].

Market Analysis

Global BRAF Kinase Inhibitors Market

The global BRAF kinase inhibitors market, which includes drugs like encorafenib, dabrafenib, sorafenib, and vemurafenib, is expected to grow significantly over the next few years.

• Market Size and Forecast: The market is projected to grow from 2025 to 2031, with encorafenib being a key player due to its efficacy and recent approvals in various indications[2].
• Segment Analysis: By type, the market is segmented into different BRAF kinase inhibitors, with encorafenib expected to capture a significant share due to its combination therapy benefits and expanding indications[2].

Regional Analysis

The market for BRAF kinase inhibitors, including encorafenib, is expected to be dominated by regions with high healthcare spending and advanced oncology treatment options.

• Europe and North America: These regions are anticipated to lead the market due to their strong healthcare infrastructure and the recent approvals of encorafenib plus binimetinib for NSCLC in Europe[2][5].

Competitive Analysis

Encorafenib competes with other BRAF inhibitors such as dabrafenib and vemurafenib. However, its combination with binimetinib has shown superior efficacy in several clinical trials.

• Key Competitors: Dabrafenib and vemurafenib are significant competitors, but the combination therapy of encorafenib and binimetinib has a unique market position due to its improved PFS and OS rates[2][4].

Market Projections

Growth Rate

The global BRAF kinase inhibitors market is expected to grow at a significant compound annual growth rate (CAGR) from 2025 to 2031, driven by increasing demand for targeted therapies in oncology.

• CAGR: The market is projected to have a CAGR that reflects the growing need for effective treatments for BRAF-mutant cancers, with encorafenib being a major contributor to this growth[2].

Expanding Indications

Encorafenib's recent approval for NSCLC and its ongoing clinical trials in other cancer types are expected to expand its market reach.

• New Indications: The approval for NSCLC and potential future approvals in other cancers, such as colorectal cancer, will further boost the market share of encorafenib[5].

Safety and Tolerability

Adverse Effects

Clinical trials have shown that encorafenib plus binimetinib has a manageable safety profile, although it is associated with certain adverse effects.

• Common Adverse Effects: Grade 3 or higher treatment-related adverse effects (TRAEs) include myocarditis, adrenal insufficiency, and other common side effects associated with BRAF and MEK inhibitors[1][3].

Expert Insights

"The EC approval highlights our ongoing commitment to bring meaningful change to patients with diseases such as lung cancer where there is a high unmet need." - Núria Perez-Cullell, head of Medical, Patient, and Consumer Affairs at Pierre Fabre Laboratories[5].

Key Takeaways

• Clinical Efficacy: Encorafenib plus binimetinib has demonstrated superior PFS and OS rates compared to vemurafenib in BRAF V600E/K-mutant metastatic melanoma.
• Market Growth: The global BRAF kinase inhibitors market is expected to grow significantly, with encorafenib playing a key role due to its expanding indications.
• Safety Profile: The combination therapy has a manageable safety profile, although it is associated with certain adverse effects.
• Expanding Indications: Recent approval for NSCLC and potential future approvals in other cancers will further boost its market share.

FAQs

What is the primary indication for encorafenib?

Encorafenib is primarily indicated for the treatment of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, and recently approved for BRAF V600E-mutated advanced NSCLC.

How does encorafenib compare to other BRAF inhibitors in clinical trials?

Encorafenib in combination with binimetinib has shown superior PFS and OS rates compared to vemurafenib in clinical trials for BRAF V600E/K-mutant metastatic melanoma.

What are the common adverse effects associated with encorafenib plus binimetinib?

Common adverse effects include myocarditis, adrenal insufficiency, and other side effects typical of BRAF and MEK inhibitors.

What is the current market outlook for encorafenib?

The market for encorafenib is expected to grow significantly due to its efficacy, recent approvals, and expanding indications in various cancers.

Are there ongoing clinical trials for encorafenib in other cancer types?

Yes, encorafenib is being evaluated in ongoing clinical trials for other cancer types, including colorectal cancer and NSCLC.

Sources

1. COLUMBUS 7-year update: A randomized, open-label, phase III trial ... - PubMed
2. BRAF Kinase Inhibitors Market Report 2024 (Global Edition) - Cognitivemarketresearch
3. Encorafenib/Binimetinib Induction Before Nivolumab/Ipilimumab ... - Onclive
4. BRAFTOVI® (encorafenib) Clinical Studies - Pfizer Medical Information - Pfizer Medical Information
5. Encorafenib/Binimetinib Combo Approved in Europe for BRAF ... - Onclive