CLINICAL TRIALS PROFILE FOR EPKINLY

All Clinical Trials for EPKINLY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04623541 ↗	Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome	Recruiting	AbbVie	Phase 1/Phase 2	2020-11-25	The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.
NCT04623541 ↗	Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome	Recruiting	Genmab	Phase 1/Phase 2	2020-11-25	The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.
NCT06112847 ↗	Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2024-01-24	This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens (the part of the target that the antibody attaches to), at the same time. This dual action allows bispecific antibodies to improve target specificity by binding two antigens on the same cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and epcoritamab, when given together, may be more effective in treating patients with follicular lymphoma than if they were given alone.
NCT06112847 ↗	Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma	Recruiting	City of Hope Medical Center	Phase 2	2024-01-24	This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens (the part of the target that the antibody attaches to), at the same time. This dual action allows bispecific antibodies to improve target specificity by binding two antigens on the same cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and epcoritamab, when given together, may be more effective in treating patients with follicular lymphoma than if they were given alone.

Clinical Trial Conditions for EPKINLY

Condition Name

Condition Name for EPKINLY
Intervention	Trials
Follicular Lymphoma	1
Follicular Lymphoma (FL)	1
Relapsed/Refractory Chronic Lymphocytic Leukemia	1
Richter's Syndrome	1

Condition MeSH

Condition MeSH for EPKINLY
Intervention	Trials
Lymphoma, Follicular	2
Lymphoma	2
Lymphoma, Large B-Cell, Diffuse	1
Syndrome	1

Clinical Trial Locations for EPKINLY

Trials by Country

Trials by Country for EPKINLY
Location	Trials
United States	24
France	6
Israel	6
Spain	5
Australia	5

Trials by US State

Trials by US State for EPKINLY
Location	Trials
Washington	2
Ohio	2
New York	2
Florida	2
California	2

Clinical Trial Progress for EPKINLY

Clinical Trial Phase

Clinical Trial Phase for EPKINLY
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EPKINLY
Clinical Trial Phase	Trials
Recruiting	3
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for EPKINLY

Sponsor Name

Sponsor Name for EPKINLY
Sponsor	Trials
Genmab	3
AbbVie	3
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for EPKINLY
Sponsor	Trials
Industry	6
NIH	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for EPKINLY (Relatlimab and Nivolumab)

Last updated: February 4, 2026

Summary
EPKINLY (generic: relatlimab and nivolumab) gained FDA approval on August 18, 2022, for unresectable or metastatic melanoma, marking its entry as a first-in-class combination immunotherapy. Since approval, clinical trial activity has focused on expanding indications and evaluating long-term efficacy. Market adoption prospects hinge on competition, regulatory strategies, and clinical outcomes.

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What Are the Latest Clinical Trial Updates for EPKINLY?

Post-Approval Clinical Trials
Following FDA approval, ongoing studies have sought to solidify EPKINLY’s positioning. Significant updates include:

• LAG-3 Inhibition: The combination targets LAG-3 (relatlimab) and PD-1 (nivolumab). LAG-3’s role as a immune checkpoint is under active investigation, with trials assessing monotherapy versus combination efficacy versus existing standards.

• Key ongoing trials:

  • RELATIVITY-047 (NCT03470922): Completed, demonstrated progression-free survival (PFS) benefits over nivolumab alone in melanoma, with median PFS of 10.1 months versus 4.6 months (hazard ratio [HR] 0.75, 95% CI 0.59–0.96).

  • Relatlimab + Nivolumab in Other Cancers: Multiple phase 2/3 trials investigating efficacy in lung cancer, head and neck cancers, and renal cell carcinoma are ongoing. These trials often have primary endpoints of Objective Response Rate (ORR) and PFS.

Safety and Tolerability
Post-marketing data have reported adverse events consistent with immune checkpoint inhibitors, including fatigue, rash, diarrhea, and elevations in liver enzymes. No new safety signals currently restrict clinical use.

Biomarker Development
Further research is underway to identify predictive biomarkers for response, potentially improving patient selection and outcomes.

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What Is the Market Landscape for EPKINLY?

Market Size and Revenue Potential
The global melanoma treatment market was valued at approximately $2.8 billion in 2022 and projected to grow at a compound annual growth rate (CAGR) of 10% — reaching $4.8 billion by 2030 [1].

Key Competitors
EPKINLY competes primarily with pembrolizumab (Keytruda), nivolumab (Opdivo), and the combination of nivolumab + ipilimumab (Yervoy). The following highlights the competitive environment:

Drug/Combination	Indication	Market Launch Year	Estimated 2022 Revenue	Notes
pembrolizumab	Melanoma	2014	$14.4 billion	Leader in checkpoint inhibitors
nivolumab	Melanoma	2014	$9.3 billion	Broader approved indications
nivolumab + ipilimumab	Melanoma	2015	$3.5 billion	Approved for metastatic melanoma, high toxicity risk

Market Positioning
EPKINLY offers a potentially favorable safety profile and unique mechanism targeting LAG-3, which may increase efficacy in patients resistant to PD-1 monotherapy. Its positioning relies on demonstrating superior long-term survival and manageable safety versus existing therapies.

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What Are the Market Projections for EPKINLY?

Key Drivers

• Expanded Indications: Trials are underway to expand into lung, head and neck, and renal cancers, each adding to the revenue potential.
• Combination Strategies: With ongoing trials exploring combinations with chemotherapies and targeted agents, market penetration could accelerate.

Sales Forecasts

• 2023–2025: Initial sales are projected at approximately $250 million, based on uptake in melanoma, mostly driven by second-line and adjuvant settings.
• 2026–2030: Annual sales could reach $1.2–1.5 billion if efficacy in other cancers is validated, and if real-world evidence confirms long-term benefits [2].

Market Challenges

• Competitive Landscape: Nivolumab and pembrolizumab dominate, with high brand loyalty and established reimbursement pathways.
• Cost and Reimbursement: EPKINLY’s pricing strategy will influence market access. Cost-effectiveness compared to monotherapies and combination regimens remains under review.

Regulatory Pathways

• Additional approvals in metastatic or adjuvant settings require robust trial results. Regulatory agencies will demand evidence of superiority or specific population benefits.
• Orphan or accelerated approvals could facilitate rapid entry into niche indications.

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Summary of Key Data Points

Aspect	Data
FDA approval date	August 18, 2022
Primary indication	Unresectable or metastatic melanoma
Clinical success (RELATIVITY-047)	Median PFS: 10.1 months vs 4.6 months (nivolumab alone)
Estimated 2022 revenue	$0.3 billion (initial sales)
Projected 2025 revenue	$0.5–0.75 billion
Projected 2030 revenue	$1.2–1.5 billion

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Key Takeaways

• EPKINLY represents a novel immune checkpoint inhibitor combining relatlimab (LAG-3) with nivolumab (PD-1).
• The drug’s clinical efficacy in melanoma has been demonstrated via PFS improvements, with ongoing trials exploring broader indications.
• Its market potential hinges on demonstrating advantages over existing PD-1 therapies and obtaining approvals for additional cancers.
• Revenue growth is expected if trials prove successful; competition remains intense with dominant PD-1 monotherapies.
• Cost, safety profile, and biomarker-driven patient selection will influence market adoption.

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FAQs

1. How does EPKINLY differ from other immune checkpoint inhibitors?
EPKINLY combines relatlimab, a LAG-3 inhibitor, with nivolumab, targeting different immune checkpoints, potentially offering superior efficacy in some patients with melanoma resistant to PD-1 monotherapy.

2. What are the primary clinical benefits observed so far?
In the RELATIVITY-047 trial, EPKINLY improved progression-free survival (median 10.1 months) over nivolumab alone (median 4.6 months) in untreated melanoma.

3. What are the main safety concerns with EPKINLY?
The adverse events align with immune checkpoint inhibitors, including fatigue, rash, diarrhea, and transaminase elevations. No new safety signals have emerged since approval.

4. Which cancers does EPKINLY aim to treat beyond melanoma?
Trials are exploring non-small cell lung cancer, head and neck squamous cell carcinoma, and renal cell carcinoma.

5. What is the competitive edge of EPKINLY?
Its mechanism of targeting LAG-3 alongside PD-1 may enhance immune response and overcome resistance seen with PD-1 monotherapy, potentially broadening its clinical utility.

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References

[1] MarketWatch, "Global Melanoma Therapeutics Market," 2023.
[2] EvaluatePharma, "Oncology Market Outlook," 2023.