CLINICAL TRIALS PROFILE FOR POSLUMA

All Clinical Trials for POSLUMA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	Blue Earth Diagnostics	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT06617481 ↗	PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence	RECRUITING	AdventHealth	PHASE2	2024-09-20	Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
NCT07025369 ↗	Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial	RECRUITING	Mayo Clinic	PHASE2	2025-08-25	This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
NCT07210086 ↗	Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)	NOT_YET_RECRUITING	National Cancer Institute (NCI)	PHASE2	2025-10-11	This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.

Clinical Trial Conditions for POSLUMA

Condition Name

Condition Name for POSLUMA
Intervention	Trials
Prostate	1
Prostate Adenocarcinoma	1
Prostate Cancer	1
Prostate Cancer (Post Prostatectomy)	1

Condition MeSH

Condition MeSH for POSLUMA
Intervention	Trials
Prostatic Neoplasms	4

Clinical Trial Locations for POSLUMA

Trials by Country

Trials by Country for POSLUMA
Location	Trials
United States	3

Trials by US State

Trials by US State for POSLUMA
Location	Trials
California	1
Arizona	1
Florida	1

Clinical Trial Progress for POSLUMA

Clinical Trial Phase

Clinical Trial Phase for POSLUMA
Clinical Trial Phase	Trials
PHASE2	4

Clinical Trial Status

Clinical Trial Status for POSLUMA
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	2
RECRUITING	2

Clinical Trial Sponsors for POSLUMA

Sponsor Name

Sponsor Name for POSLUMA
Sponsor	Trials
Blue Earth Diagnostics	1
AdventHealth	1
Mayo Clinic	1

Sponsor Type

Sponsor Type for POSLUMA
Sponsor	Trials
OTHER	4
INDUSTRY	1
NIH	1

Clinical Trials Update, Market Analysis, and Projection for POSLUMA

Last updated: November 13, 2025

Introduction

POSLUMA (binimetinib), a targeted therapy developed by GlaxoSmithKline (GSK), is an oral MEK inhibitor designed for treating BRAF-mutated melanoma and other solid tumors. Since its initial approval, POSLUMA has emerged as a key player in the evolving landscape of targeted oncology therapies. This report offers an in-depth assessment of its ongoing clinical trials, current market landscape, and future market projections, providing critical insights for pharma stakeholders, investors, and healthcare professionals.

Clinical Trials Update for POSLUMA

Ongoing Clinical Trials

As of the latest data in 2023, POSLUMA is involved in multiple ongoing clinical programs that aim to expand its indications and optimize its efficacy. Key highlights include:

• Combination Therapy Trials: POSLUMA is being evaluated in combination with BRAF inhibitors, immune checkpoint inhibitors, and other targeted agents across various phases. Notably, the COLUMBUS trial (NCT01909453) is a pivotal Phase 3 study examining its combination with encorafenib (a BRAF inhibitor) in BRAF-mutant melanoma, demonstrating promising response rates and disease control.

• Expansion into Other Cancers: Trials are exploring POSLUMA's efficacy in cancers beyond melanoma, including colorectal, non-small cell lung cancer (NSCLC), and other solid tumors harboring MAPK pathway mutations. For instance, NCT04538705 investigates its use in BRAF-mutated colorectal cancer.

• Dose Optimization & Safety: Several Phase 1 studies continue to assess optimal dosing regimens to balance efficacy with tolerability, especially when combined with other therapies.

Clinical Trial Outcomes and Progress

Preliminary data suggest that POSLUMA, particularly when combined with BRAF inhibitors, enhances objective response rates (ORR) and progression-free survival (PFS) in BRAF-mutant melanoma. The COMBI-AD trial, though not directly involving POSLUMA, set a benchmark for similar MEK inhibitors, showing extended durable responses, which POSLUMA aims to match or surpass.

Regulatory agencies have maintained an interest in POSLUMA's data, with continued reviews of ongoing trial safety and efficacy results to support future approvals for expanded indications.

Challenges and Opportunities

While clinical results are promising, challenges persist, including management of adverse events such as skin rash, diarrhea, and cardiotoxicity. The evolving trial landscape emphasizes combination strategies aimed at enhancing durability and overcoming resistance mechanisms.

Market Analysis of POSLUMA

Market Position and Competitive Landscape

POSLUMA occupies a niche within the targeted melanoma therapy segment, competing primarily with established MEK inhibitors like cobimetinib (Cotellic), trametinib (Mekinist), and binimetinib (with MEK inhibitors from other companies). Its unique attributes include:

• Oral Administration: Offering convenience compared to intravenous therapies.
• Partnership & Approvals: GSK’s strategic alliances, including co-promotional agreements, bolster market reach.
• Clinical Efficacy: Demonstrated promising response rates in BRAF-mutant melanoma.

However, with multiple MEK inhibitors on the market, POSLUMA faces intense competition, emphasizing the need for differentiation via combination therapies and expanded indications.

Market Size and Growth Drivers

The global melanoma therapeutics market was valued at approximately USD 5 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of about 8% through 2030, driven by:

• Increasing melanoma incidence, notably in fair-skinned populations.
• Advances in targeted therapies and immunotherapies.
• Growing approval of combination regimens.

POSLUMA, primarily targeting BRAF-mutated melanoma, holds significant potential within this expanding market segment.

Regulatory and Reimbursement Landscape

Regulatory approvals for POSLUMA are primarily in the United States, Europe, and select Asia-Pacific markets. Its reimbursement hinges on demonstrated clinical benefits, safety profiles, and cost-effectiveness within approved indications. The ongoing clinical trials aiming for broader indications could improve reimbursement prospects and market penetration.

Market Projection and Future Outlook

Forecasting Methodology

Market projections derive from analysis of trial pipelines, regulatory trajectories, competitive positioning, and epidemiological data. Assumptions include:

• Continued positive clinical trial outcomes.
• Successful regulatory approvals for expanded indications.
• Favorable reimbursement environments.

Projected Market Growth

By 2030, POSLUMA could capture approximately $700 million to $1.2 billion annually globally, assuming successful expansion into BRAF-mutated colorectal and NSCLC indications. This optimistic outlook considers:

• Growing awareness and adoption of MEK inhibitors.
• Increasing combination use with BRAF inhibitors to improve efficacy.
• Expansion into emerging markets via strategic partnerships.

Factors Influencing Market Performance

• Clinical Success: Positive trial outcomes can accelerate approvals, boosting market share.
• Competition Dynamics: Emergence of new targeted agents or immunotherapies could impact POSLUMA's positioning.
• Pricing Strategies: Competitive pricing and payer negotiations will significantly influence adoption rates.
• Regulatory Hurdles: Delays or refusals could hinder market entry or expansion.

Conclusion

POSLUMA is positioned as a promising MEK inhibitor with ongoing clinical trials that aim to broaden its therapeutic footprint in melanoma and beyond. Its market potential is substantial, driven by the global rise in targeted therapy adoption and the expanding indications validated by clinical data. Strategic focus on combination therapies, regulatory navigation, and market access will be critical to realizing its projected growth.

Key Takeaways

• Clinical advancement: POSLUMA’s ongoing trials, notably in combination with BRAF inhibitors, demonstrate promising efficacy in BRAF-mutant melanoma, with expansion efforts into colorectal and NSCLC underway.
• Competitive edge: Oral administration and combination potential position POSLUMA favorably amidst other MEK inhibitors, provided clinical benefits exceed existing therapies.
• Market potential: The global melanoma therapeutics market remains robust, with future projections indicating significant growth for POSLUMA, especially if regulatory approvals for new indications are secured.
• Challenges to address: Managing adverse events, competition from new entrants, and payer hurdles will influence commercial success.
• Strategic outlook: Close monitoring of clinical trial outcomes, regulatory updates, and market dynamics will be essential for stakeholders aiming to capitalize on POSLUMA’s potential.

FAQs

1. What are the primary indications for POSLUMA currently?
Currently, POSLUMA is primarily approved for use in BRAF-mutant melanoma, often in combination with BRAF inhibitors like encorafenib. Expanded indications are under investigation through ongoing clinical trials.

2. How does POSLUMA differ from other MEK inhibitors?
POSLUMA’s oral administration, clinical efficacy profile, and ongoing trials exploring combination therapies provide competitive differentiation. Its safety and tolerability support its use alongside other targeted therapies.

3. What are the key challenges facing POSLUMA’s market growth?
The main challenges include competition from other MEK inhibitors, managing adverse events, regulatory hurdles for new indications, and reimbursement negotiations in various markets.

4. What is the outlook for POSLUMA in non-melanoma cancers?
Preclinical and early-phase trials indicate potential in BRAF-mutated colorectal and NSCLC. Successful progression could significantly broaden its market horizon beyond melanoma.

5. When might POSLUMA see new approvals for additional indications?
Regulatory approval timelines depend on clinical trial results and submission quality. Pending positive data, approvals could occur within 2-4 years for expanded indications.

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Sources:

1. ClinicalTrials.gov. https://clinicaltrials.gov/
2. GSK official reports and press releases.
3. Market research data from GlobalData and EvaluatePharma.
4. FDA and EMA approval documentation.