NICE Recommends Subcutaneous Treatment Option Tepkinly® ▼ (epcoritamab) for Eligible* Adults with Aggressive Form of Blood Cancer After Two or More Lines of Systemic Therapy

• For the first time, adults with diffuse large B-cell lymphoma (DLBCL), whose cancer has returned or not responded to at least two prior treatments, only if they have previously had polatuzumab vedotin or it is contraindicated or not tolerated, will have access to a subcutaneous bispecific treatment option administered as an injection under the skin^1,2

• Epcoritamab is part of a new class of therapies called bispecific antibodies. Bispecific antibodies help the body’s immune system to attack and destroy cancerous cells³

• DLBCL is an aggressive blood cancer, with nearly 5,500 new diagnoses in the UK each year⁴. For around 700 of these patients whose cancer has returned or has not responded to at least two prior treatments, prognosis is poor^5,6

MAIDENHEAD, UK, [1^st February 2024] – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly^® (epcoritamab) as a treatment option for adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has not responded to at least two previous treatments, only if they have previously had polatuzumab vedotin or it is contraindicated or not tolerated¹.

The NICE recommendation is based on the single-arm Phase 1/2 EPCORE NHL-1 trial data, which demonstrated a 62% (n=86/139) overall response rate, meaning 62% of participants’ blood cancer either went down by half (partial response) or showed no evidence of disease from tests and scans (a complete response)^2,7. The complete response rate was 39% (n=54/139), meaning there was no evidence of disease from tests and scans in 39% of these hard-to-treat patients, who on average had already been through three types of treatment before starting the trial^2,7,8,9.

“Diffuse large B-cell lymphoma is a type of blood cancer and, while most people go into remission after standard treatment, some people can see their cancer return. Like many that experience blood cancer, people with relapsed or refractory DLBCL experience anxiety around the prospect of not responding to treatment or the cancer once again returning,” said Rincy George, Policy Officer at Blood Cancer UK.

“Epcoritamab (Tepkinly), is an injectable bispecific antibody designed to recognise and attach to the cancer cells and immune cells, so that the body’s immune system can destroy them. Today’s decision from NICE approving epcoritamab for eligible patients for use on the NHS in England and Wales is a welcome step for many.”

DLBCL is an aggressive blood cancer, with nearly 5,500 new diagnoses in the UK each year⁴. For around 700 of these patients who have relapsed or refractory (R/R) DLBCL, meaning their cancer has returned or has not responded to at least two prior treatments, prognosis is poor^5,6. There are few treatments available for this patient population, and these are typically administered intravenously, via a needle or tube inserted into a vein, in a hospital setting¹⁰. While epcoritamab is also given in a hospital setting, it is administered subcutaneously, meaning it is an injection under the skin¹.

Epcoritamab is part of a new class of therapies called bispecific antibodies. Bispecific antibodies help the body’s immune system to attack and destroy cancerous cells. 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^2,3.

“Despite recent therapeutic advances, treatment options for this hard-to-treat group of patients have been limited. This can mean many patients do not have suitably effective treatment options, resulting in a poor prognosis,” said Professor Chris Fox, Professor of Haematology, School of Medicine, University of Nottingham and Honorary Consultant Haematologist, Nottingham University Hospitals NHS Trust.

“Today’s decision by NICE on epcoritamab provides physicians with a second bispecific antibody as a treatment option for eligible patients with relapsed or refractory diffuse large B cell lymphoma after two or more lines of therapy. Epcoritamab is the first bispecific to be given as a subcutaneous injection which gives patients and clinicians an additional choice of administration option, which may help to support capacity planning within lymphoma services. The decision by NICE will be welcomed by both patients and the clinical community.”

In contrast to some existing therapeutic options, epcoritamab does not require cell collection and engineering¹. The treatment is given by a blood cancer specialist doctor or nurse to eligible patients as an injection under the skin, weekly for 12 weeks, then every other week for 24 weeks (12 injections), before continuing as one injection every 4 weeks until treatment is discontinued, either due to cancer progression or side effects¹. Eligible patients can start epcoritamab therapy after appropriate pre-medication has been administered and monitoring for adverse events is available¹. Patients stay in hospital for 24 hours after the first full dose to monitor for side effects¹.

In the Phase 1/2 NHL-1 clinical trial, epcoritamab prevented growth or spread of the cancer for an average of 15.6 months, and the patients lived for an average of 19.4 months from the start of epcoritamab therapy^2,7. The most common adverse reactions of any grade (≥20%) observed in the trial were cytokine release syndrome (CRS), fatigue, neutropenia, injection-site reactions, abdominal pain, pyrexia, nausea and diarrhoea².

“AbbVie is committed to advancing care for people living with blood cancer”, said Belinda Byrne, Medical Director, AbbVie UK. “We are delighted that NICE has recognised the benefit that epcoritamab can have on the lives of people living with R/R DLBCL. We will continue working closely with the relevant authorities to provide equitable access across the UK for eligible R/R DLBCL patients in need.”

*For adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has not responded to at least two previous treatments, only if they have previously had polatuzumab vedotin or it is contraindicated or not tolerated.

-Ends-

UK media contact:
Rachael Pink

AbbVie UK
T: +44 (0)7816 180 570
E: rachael.pink@abbvie.com

NOTES TO EDITORS:

Glossary
Complete response rate of 39% (n=54/139)^2,7: 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^8,9.
Median duration of response of 15.6 months^2,7: The average length of time that a tumour continues to respond to treatment without the cancer growing or spreading¹¹.
Median overall survival of 19.4 months^2,7: The average time patients live for from the time they start treatment with epcoritamab¹¹.
Overall response rate of 62% (n=86/139)^2,7: The total number of people in the trial whose blood cancer either went down by half (partial response) or showed no evidence of disease from tests and scans (complete response)^8,9.
Refractory: Lymphoma that does not respond well to the previous treatments, and patient does not go into remission⁴.
Relapse: Lymphoma that comes back after successful treatment and a period of remission⁴.
Remission: When there is no evidence of lymphoma in the body from tests and scans after treatment, and no symptoms⁴.

About DLBCL
Lymphoma is a blood cancer that causes tumours to form in the lymphatic system⁴. Lymphoma is divided into two main types called Hodgkin’s lymphoma and NHL¹². DLBCL is a type of NHL and makes up almost 30% of all cases of NHL globally¹³. There are approximately 5,500 new cases of DLBCL in the UK each year⁴. For around 700 of these patients whose cancer has returned or has not responded to at least two prior treatments, prognosis is poor^5,6. Patients with DLBCL typically have swollen lymph nodes in the neck, armpit or groin⁴.

About Tepkinly (epcoritamab)
Epcoritamab is recommended by NICE as a subcutaneous injection to treat adults in England and Wales with DLBCL that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received two or more treatments for their cancer, only if they have previously had polatuzumab vedotin or it is contraindicated or not tolerated¹. The treatment is given by a blood cancer specialist doctor or nurse to eligible patients as an injection under the skin, weekly for 12 weeks, then every other week for 24 weeks (12 injections), before continuing as one injection every 4 weeks until treatment is discontinued, either due to cancer progression or side effects².

Epcoritamab is an immunoglobulin G1-bispecific antibody created using Genmab’s proprietary DuoBody^® technology³. Genmab’s DuoBody^®-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types³. 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+ cells³. CD20 is expressed on B cells and is a clinically validated therapeutic target in many B-cell malignancies, including DLBCL^14,15. Epcoritamab was designed specifically for high-specificity binding.³ 

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. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.

About the EPCORE™ NHL-1 clinical trial^16,17
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 DLBCL. Data from the dose escalation part of the study, which determined the recommended Phase 2 dose, were published in September 2021. In the Phase 2 expansion part, additional patients were treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-cell NHLs who had limited therapeutic options.

The primary endpoint of the Phase 2 expansion part was overall response rate as assessed by an independent review committee. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy and rate of minimal residual disease negativity. The most common adverse reactions of any grade (≥20%) observed in the trial were CRS (50.9%), fatigue (30.5%), neutropenia (30.5%), injection-site reactions (29.9%), pyrexia (23.4%), abdominal pain (23.4%), nausea (21.6%) and diarrhoea (21.0%). The most common Grade 3–4 adverse reactions (≥2%) were neutropenia (23.4%), anaemia (10.2%), thrombocytopenia (7.2%), pneumonia (6.0%), fatigue (3.0%), CRS (3.0%), febrile neutropenia (2.4%), oedema (2.4%) and hypophosphataemia (2.4%). The most common serious adverse reactions (≥2%) were CRS (31.1%), pneumonia (7.2%), upper respiratory tract infections (2.4%), febrile neutropenia (2.4%), immune effector cell-associated neurotoxicity syndrome (ICANS; 2.4%) and pyrexia (2.4%). Four patients (2.4%) experienced a fatal adverse reaction (ICANS in one patient [0.6%] and pneumonia in three patients [1.8%]).

Results from the Phase 2 expansion part of the study were published in December 2022. More information can be found at https://classic.clinicaltrials.gov/ct2/show/NCT03625037.

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 20 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.

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 @abbvieuk on X, formally known as Twitter, and YouTube.

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

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2. Tepkinly GB summary of product characteristics.

3. 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.

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17. ClinicalTrials.gov. First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1). NCT03625037. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT03625037 [Last accessed: January 2024].