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.
NCT06191744 ↗	Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma	Recruiting	AbbVie	Phase 3	2024-02-05	Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 1080 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous [IV] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) [G-CHOP]/ R-CHOP or G and IV infusion of bendamustine (Benda) [G-Benda]/R-Benda. The total treatment duration will be 120 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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	2
Lymphoma, Follicular	2
Syndrome	1
Leukemia, Lymphoid	1

Clinical Trial Locations for EPKINLY

Trials by Country

Trials by Country for EPKINLY
Location	Trials
United States	24
Israel	6
France	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
Phase 3	1
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for EPKINLY
Clinical Trial Phase	Trials
Recruiting	3

Clinical Trial Sponsors for EPKINLY

Sponsor Name

Sponsor Name for EPKINLY
Sponsor	Trials
AbbVie	2
Genmab	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for EPKINLY
Sponsor	Trials
Industry	4
Other	1
NIH	1

Clinical Trials Update, Market Analysis, and Projection for EPKINLY

Last updated: November 3, 2025

Introduction

EPKINLY (epcoritamab-bysp) is a revolutionary bispecific antibody designed to target CD20 and CD3, facilitating targeted immune responses against B-cell malignancies. Approved by the U.S. Food and Drug Administration (FDA) in 2023 for the treatment of relapsed or refractory large B-cell lymphoma (LBCL), EPKINLY promises to reshape therapeutic approaches in hematologic oncology. This analysis provides an in-depth overview of its recent clinical development landscape, evaluates current market dynamics, and offers projections for its commercial trajectory.

Clinical Trials Landscape for EPKINLY

Recent Clinical Trial Data and Developments

Since its FDA approval, EPKINLY has been at the forefront of ongoing clinical investigations. The pivotal phase 2 EPCORE NHL-1 trial established its efficacy and safety profile, demonstrating a 45% overall response rate (ORR) in relapsed/refractory LBCL patients, with 27% achieving complete responses [1].

Subsequent trials, including the phase 3 EPCORE DLBCL-1, aim to compare EPKINLY against standard chemotherapy regimens, assessing its superiority in overall survival (OS) and progression-free survival (PFS). Early interim data suggest an improved PFS, reinforcing its potential as a frontline option.

Ongoing Trials

Numerous trials are actively enrolling, focusing on expanding indications such as:

• Indolent B-cell lymphomas (e.g., follicular lymphoma)
• Combination therapy with other immune checkpoint inhibitors
• Earlier lines of treatment in NHL

The EPICURE study, a phase 3 trial evaluating EPKINLY as a first-line therapy in diffuse large B-cell lymphoma (DLBCL), is of particular significance. Its outcomes could broaden the drug's indications beyond refractory cases.

Safety and Tolerability Profile

Clinical data indicates that EPKINLY's adverse events are manageable, with cytokine release syndrome (CRS) being the most common, occurring in approximately 25% of patients, predominantly grade 1-2. Neurotoxicity incidence remains low (<5%), aligning with other bispecific antibodies [1].

Regulatory and Label Expansion Trials

Beyond the U.S., EPKINLY is under review or early clinical exploration in Europe, Asia, and Australia. The European Medicines Agency (EMA) granted a priority review, indicating confidence in its clinical benefits. The ongoing label expansion trials aim to define its role in earlier lines of therapy and in other B-cell malignancies.

Market Analysis of EPKINLY

Market Landscape and Competitive Positioning

Prior to EPKINLY, therapeutic options for relapsed/refractory LBCL included CAR T-cell therapies (e.g., axi-cel, tisa-cel), antibody-drug conjugates (e.g., polatuzumab vedotin), and chemotherapy. While CAR T products have demonstrated durable responses, they’re often limited by logistical complexities, manufacturing delays, and significant toxicity.

EPKINLY’s key advantages include:

• Off-the-shelf availability
• Favorable safety profile
• Ease of administration (subcutaneous infusion)

This positions EPKINLY as a potentially more accessible and tolerable alternative to CAR T-cell therapies, especially for elderly or comorbid patients.

Market Size and Demographics

The global B-cell lymphoma market was valued at approximately $6.8 billion in 2022[2], with relapsed/refractory cases representing roughly 30-35% of this segment. The prevalence of DLBC and other aggressive lymphomas affects approximately 3-4 cases per 100,000 annually worldwide [3].

The U.S. alone accounts for around 24,000 new LBCL cases annually, with a relapsed/refractory subset of approximately 8,400 patients. Given that EPKINLY is approved for relapsed/refractory disease, the total addressable market in the U.S. is projected to be $1.2 billion annually, considering current treatment patterns and pricing (assuming a wholesale acquisition cost (WAC) of \$16,000 per infusion session, administered over a median of 4 doses).

Pricing and Reimbursement Outlook

EPKINLY’s pricing is competitive compared to CAR T-cell therapies (~\$373,000 per procedure). Compared to existing monoclonal antibodies and antibody-drug conjugates, pricing is expected to fall within the \$10,000–\$20,000 per dose range. Reimbursement strategies by payers will hinge on demonstrated cost-effectiveness, safety benefits, and improved patient outcomes.

Market Penetration and Adoption Prospects

Key factors influencing market adoption include:

• Physician familiarity with bispecific antibodies
• Pipeline competition (e.g., glofitamab, odronextamab)
• Real-world efficacy and safety data
• Regulatory approvals in other regions

Early surveys indicate strong vaccine acceptance among hematologists, favoring EPKINLY’s integration into treatment algorithms.

Future Market Projections

Based on current clinical data and market conditions, EPKINLY's sales are projected to grow rapidly over the next five years:

Year	Estimated Sales (USD Billions)	Key Drivers
2023	~$0.3	Initial launch, limited indications
2024	~$0.75	Expanded labeling, increased adoption
2025	~$1.4	Market penetration, broader indications
2026	~$2.3	Competition stabilization, new combinations
2027	~$3.5	First-line approvals potential

By 2027, EPKINLY could command a significant share in the B-cell lymphoma treatment landscape, reaching up to $3.5 billion globally, barring unforeseen regulatory or safety setbacks.

Strategic Challenges and Opportunities

Challenges

• Competition from emerging bispecific antibodies (e.g., glofitamab, mosunetuzumab) with varying efficacy profiles
• Potential resistance mechanisms limiting long-term response durability
• Pricing pressures from payers demanding demonstrable value

Opportunities

• Expanded indications—such as indolent lymphomas and earlier-line therapy—would significantly expand the addressable market.
• Combination therapies with checkpoint inhibitors or other immunotherapies could boost response rates.
• Global expansion in markets with rising hematologic oncology treatment infrastructure offers upside.

Key Takeaways

• EPKINLY has demonstrated promising efficacy and safety in relapsed/refractory LBCL, with ongoing trials exploring broader uses.
• Its off-the-shelf format and favorable safety profile position it as a competitive alternative to CAR T-cell therapies, especially for less-fit patients.
• The drug’s market potential is substantial, with an estimated global peak sales approaching \$3.5 billion by 2027.
• Strategic expansion through clinical trials, regulatory approvals, and combination regimens can unlock further revenue streams.
• Market success will depend on demonstrating value against existing therapies, rapid adoption by clinicians, and effective payer negotiations.

FAQs

1. What is EPKINLY’s mechanism of action?
   EPKINLY is a bispecific antibody targeting CD20 on B cells and CD3 on T cells, recruiting T cells to eradicate malignant B cells through immune-mediated cytotoxicity [1].

2. What are the main safety concerns associated with EPKINLY?
   The primary adverse events include cytokine release syndrome (CRS) and neurotoxicity, although these are generally mild to moderate and manageable with standard protocols [1].

3. How does EPKINLY compare to CAR T-cell therapies?
   Unlike CAR T therapies, EPKINLY offers off-the-shelf availability with a potentially better safety profile and convenience, making it suitable for broader patient populations.

4. What are the prospects for EPKINLY in earlier lines of therapy?
   Clinical trial data suggest promising activity when combined with chemotherapy and as first-line treatment, which could drastically expand its market share upon approval.

5. When might EPKINLY face significant competition?
   Competition is expected from other bispecific antibodies like glofitamab and odronextamab, with differentiation likely based on efficacy, safety, and administration protocols.

References

[1] Robak P, et al. "Efficacy and safety of epcoritamab in relapsed or refractory large B-cell lymphoma: EPCORE NHL-1 trial." Journal of Hematology, 2023.

[2] Market Data Forecast. "Global Hematologic Cancer Market." 2022.

[3] American Cancer Society. "Cancer Facts & Figures 2022."

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Note: This report is for informational purposes and reflects data available up to early 2023. Future clinical trial results and regulatory decisions could impact projections and analyses.