NICE Recommends TEPKINLY®▼ (epcoritamab), a Subcutaneous Bispecific Antibody for Adults With Relapsed/Refractory (R/R) Follicular Lymphoma (FL) After Two or More Lines of Systemic Therapy

• Epcoritamab can now be accessed as an option to treat relapsed or refractory follicular lymphoma in adults after 2 or more lines of systemic treatment, only if epcoritamab is stopped after 3 years of treatment or earlier if the lymphoma progresses.[1]

 

• The NICE recommendation is based on the single-arm Phase 1/2 EPCORE NHL-1 trial, where epcoritamab demonstrated responses in people whose cancer has returned or has not responded to at least two treatments.[2]

 

• Follicular lymphoma is an incurable blood cancer that affects around 2,300 people in the UK every year, it is a challenging form of cancer to treat, especially in later lines of therapy where there is no standard approach.[3]^,[4]

 

MAIDENHEAD, UK, 23 February 2026 – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly^® (epcoritamab) as an option within the NHS to treat adults with follicular lymphoma (FL) whose cancer has returned (relapsed) or not responded to at least two prior treatments (refractory) only if epcoritamab is stopped after 3 years of treatment or earlier if the lymphoma progresses. Epcoritamab is the first bispecific antibody recommended by NICE for people living with FL, offering an additional option for those in third or later lines of treatment where there is currently no standard approach.

 

The NICE recommendation is based on results from the Phase 2 cohort of the single-arm study (EPCORE NHL-1) of epcoritamab monotherapy in 128 adults with relapsed or refractory FL who had received at least two prior systemic treatments. The study reported an 82% (n=105/128) overall response rate, meaning 82% of participants’ blood cancer reduced by at least half (partial response) or showed no evidence of disease from tests and scans (a complete response).² The complete response rate was 62.5% (n=80/128), meaning there was no evidence of disease from tests and scans in 62.5% of FL patients.²

 

Follicular lymphoma is the most common form of low-grade non-Hodgkin's lymphoma (NHL), affecting 20% of people with NHL in the UK.³ It is slow growing and incurable, meaning most people with the disease will require ongoing treatment and lifelong monitoring.[5],[6] In early stages, patients may experience long periods of remission, where signs of disease are minimal or undetectable. However, patients often relapse, and each time the cancer returns, the periods of remission become shorter.^6.[7]

 

“For people with follicular lymphoma, NICE’s positive recommendation of epcoritamab means that there is now another therapy available for when their lymphoma hasn’t responded to at least two treatments and their options have become increasingly limited,” said Ropinder Gill, Chief Executive at Lymphoma Action.

 

“We know from talking to people with follicular lymphoma just how deeply each relapse impacts both emotional wellbeing and physical health, causing growing anxiety and uncertainty. We very much welcome this decision as it addresses an urgent need for those who face the challenge of having limited treatments available to them”.

 

Epcoritamab is part of a class of therapies called bispecific antibodies, that help the body’s immune system to attack and destroy cancerous cells.[8] Epcoritamab is designed to simultaneously attach to two different cells, one immune T cell and one cancerous lymphoma cell, bringing them together, so the immune T cell is activated to destroy the cancerous lymphoma cell.⁸

 

Kim Linton, Professor of Medical Oncology at the University of Manchester and Honorary Consultant at The Christie NHS Foundation Trust, commented: “NICE’s recommendation of epcoritamab marks a significant milestone for patients and clinicians, addressing a critical gap in care for people with relapsed or refractory follicular lymphoma. As the first NICE recommended bispecific antibody therapy for this condition, epcoritamab offers an additional mechanism of action and a subcutaneous mode of administration, expanding the therapeutic landscape for an underserved population.”

Dr. Rachael Millward, Medical Director, AbbVie UK said: “At AbbVie, we are committed to transforming standards of care for people living with blood cancers, including follicular lymphoma. NICE’s positive recommendation marks a crucial milestone for patients with relapsed or refractory follicular lymphoma who have exhausted existing treatment options. Together with our partner Genmab, we are proud of this important step forward, reflecting our dedication to improving outcomes for people affected by blood cancer.”

-Ends-

UK media contact:

Rachael Pink

AbbVie UK

T: +44 7816 180570

E: rachael.pink@abbvie.com

 

NOTES TO EDITORS:

Glossary
Complete response rate: The total number of people in the trial who experienced the disappearance of all evidence of lymphoma in the body from tests and scans after treatment.[9]
Overall response rate: The total number of people in the trial whose blood cancer either went down by at least half (partial response) or showed no evidence of disease from tests and scans (complete response).⁹
Refractory: Lymphoma that does not respond well to the previous treatments, and patient does not go into remission.[10]
Relapse: Lymphoma that comes back after successful treatment and a period of remission.¹⁰
Remission: A decrease in or disappearance of signs and symptoms of cancer after treatment.[11]

About Follicular lymphoma (FL) 

Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, representing 20-30% of all lymphoma cases in the UK.³ It typically affects older adults and follows a pattern of repeated relapses, with each subsequent treatment becoming less effective and shorter-lasting.^3,7 Common signs and symptoms of FL include painless swelling of lymph nodes (often in the neck, armpit, or groin), fatigue, weight loss, fever, and night sweats.³

About epcoritamab

Epcoritamab is licensed in the UK for the treatment of adult patients with relapsed or refractory FL after two or more lines of treatment. Epcoritamab has a conditional marketing authorisation and further data are awaited.[12]

Epcoritamab is recommended by NICE to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more systemic treatments only if epcoritamab is stopped after 3 years of treatment or earlier if the lymphoma progresses.¹

Epcoritamab is an immunoglobulin G1 bispecific antibody created using Genmab’s proprietary DuoBody^® technology.⁸ Genmab’s DuoBody^®-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types.⁸ Epcoritamab is designed to simultaneously bind to cluster of differentiation (CD) 3 on T cells and CD20 on B cells, and induces T-cell-mediated killing of CD20+ cells.⁸ CD20 is expressed on B cells, and is a clinically validated therapeutic target in many B-cell malignancies.[13]^,[14] Epcoritamab was designed specifically for high-specificity binding.⁸

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialisation.

About the Phase 1/2 EPCORE^® NHL-1 trial

EPCORE™ NHL-1 is a single-arm, open-label, multicentre, safety and preliminary efficacy trial of epcoritamab that includes a Phase 1 first-in-human dose escalation part; a Phase 2a expansion part; and a dose optimisation part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The optimisation part evaluates the potential for alternative step-up dosing regimens to help minimise overall rates and severity of cytokine release syndrome (CRS).²

The primary endpoint of the expansion part was overall response rate as assessed by an independent review committee. Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. The primary endpoint of the optimisation part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab. ²

The most common grade 3-4 treatment-emergent adverse event was neutropenia, in 25% (n=32/128) of patients. Grade 1-2 cytokine release syndrome was reported in 65% (n=83/128) of patients; grade 3 cytokine release syndrome was reported in 2% (n=2/128). Immune effector cell-associated neurotoxicity syndrome was reported in 6% (n=8/128) of patients. For those in the cycle 1 optimisation cohort, the incidence of cytokine release syndrome was 49% (n=42/86), with no reported immune effector cell-associated neurotoxicity syndrome. ²

Results from the Phase 2 (dose expansion and optimisation) of the study were published in June 2024. More information can be found at: https://www.clinicaltrials.gov/study/NCT03625037.

Clicking the link above will take you to an external website that is not managed or owned by AbbVie.

About AbbVie in Oncology

At AbbVie, we are committed to transforming standards of care for multiple blood cancers, while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 35 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit www.abbvie.co.uk

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at abbvie.co.uk. Follow @abbvieuk6755  on YouTube.

References

Clicking the links below will take you to external websites that are not managed or owned by AbbVie.

 

[1] NICE. Epcoritamab for treating relapsed or refractory follicular lymphoma after 2 or more systemic treatments [ID6338]. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta11385. [Last accessed: February 2026].

[2] Linton KM, Vitolo U, Jurczak W, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024;11(8): e593-e605.

[3] Cancer Research UK. Follicular lymphoma. Available from: https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/follicular-lymphoma#:~:text=How%20common%20is%20it?,more%20painless%20swellings%20in%20the: [Last accessed: February 2026].

[4] Skarbnik AZ, Patel K. Treatment selection for patients with relapsed or refractory follicular lymphoma. Front Oncol. 2023;13:1120358. doi:10.3389/fonc.2023.1120358.

[5] Lymphoma Action. Active monitoring (watch and wait). Available from: https://lymphoma-action.org.uk/about-lymphoma-lymphoma-treatment/active-monitoring-watch-and-wait [Last accessed: February 2026].

[6] Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.

[7] Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.

[8] Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020; 52:102625.

[9] Cancer Research UK. What do Clinical trial results mean? Available from: https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/clinical-trial-results/what-do-clinical-trial-results-mean-0 [Last accessed: February 2026].

[10] Lymphoma Research Foundation. Lymphoma Journey. Available from: https://lymphoma.org/understanding-lymphoma/relapsed-and-refractory-lymphoma/ [Last accessed: February 2026].

[11] Lymphoma Action. Remission. Available from: https://lymphoma-action.org.uk/about-lymphoma-treatment-lymphoma/remission#complete [Last accessed: February 2026].

[12] Epcoritamab Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/15187/smpc#gref. [Last accessed: February 2026].

[13] Rafiq S, Butchar JP, Cheney C, et al. Comparative assessment of clinically utilized CD20-directed antibodies in chronic lymphocytic leukemia cells reveals divergent NK cell, monocyte, and macrophage properties. J Immunol. 2013;190(6):2702–2711.

[14] Singh V, Gupta D, Almasan A. Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response. J Cancer Sci Ther. 2015;7(11):347–358.