MHRA grants conditional marketing authorization for AbbVie’s Tepkinly to treat aggressive blood cancer

AbbVie today announced that the UK Medicines and Healthcare products Regulatory Agency has granted conditional Marketing Authorisation for Tepkinly^® (epcoritamab) as a monotherapy for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), after two or more systemic therapies. The conditional Marketing Authorization for Great Britain is predicated on the single-arm Phase 1/2 EPCORE NHL-1 trial data, which demonstrated a 62% (86/139) overall response rate and 39% (54/139) complete response rate in patients. Nonetheless, further data are awaited from an ongoing phase 3 confirmatory study.

Epcoritamab is the primary and only licensed subcutaneous bispecific treatment option for adult patients with R/R DLBCL after two or more lines of systemic therapy, in Great Britain. In contrast to some existing therapeutic options, epcoritamab doesn’t require cell collection and engineering. The treatment is run to eligible patients by clinicians as a weekly subcutaneous injection for 12 weeks, then moves to each other week for twenty-four weeks (12 injections), before continuing as one injection every 4 weeks until treatment is discontinued, either resulting from cancer progression or unintended effects. Eligible patients are capable of start epcoritamab therapy after appropriate pre-medication has been administered and monitoring for opposed events is on the market. Patients stay in hospital for twenty-four hours after the primary full dose to watch for unintended effects.

DLBCL is essentially the most common sub-type of non-Hodgkin’s lymphoma (NHL), an aggressive blood cancer that develops within the lymphatic system, causing B-cell lymphocytes, a variety of white blood cell, to grow abnormally. There are nearly 5,500 recent DLBCL diagnoses every year within the UK. For the roughly 700 people within the UK with R/R DLBCL who’ve already received two or more treatments and require further therapy, prognosis is poor. There are few treatments available for this patient population, and these are typically administered intravenously, via a needle or tube inserted right into a vein.

“Despite recent therapeutic advances, treatment options for patients with R/R DLBCL after two previous therapies are limited. For such patients living with one of these aggressive blood cancer, many experience disease progression and have poor prognosis”, said Professor Chris Fox, Professor of Haematology, School of Medicine, University of Nottingham and Honorary Consultant Haematologist, Nottingham University Hospitals NHS Trust. “As a novel bispecific antibody, given as a subcutaneous injection, epcoritamab offers a brand new treatment option for this difficult-to-treat patient group.”

Bispecific antibodies represent a brand new class of therapies that use the body’s immune system to kill cancer cells. Epcoritamab is a bispecific antibody designed to concurrently bind to 2 proteins, cluster of differentiation (CD) on T cells within the immune system and CD20 on cancerous B cells (a variety of white blood cell), with a purpose to induce T-cell mediated killing of cancerous B cells. By targeting two cells, epcoritamab brings the immune T cell along with the cancerous B cell and prompts the T cell to destroy the B cell. Epcoritamab should be delivered under the supervision of a healthcare skilled qualified in the usage of anti-cancer therapies with access to appropriate medical support to administer potential serious unintended effects, resembling cytokine release syndrome (CRS) events.

Common serious opposed reactions observed within the single-arm Phase 1/2 EPCORE NHL-1 trial included CRS events, pneumonia, upper respiratory tract infections, febrile neutropenia, immune effector cell-associated neurotoxicity syndrome (ICANS) and pyrexia.

The conditional Marketing Authorization is predicated on data from the single-arm Phase 1/2 EPCORE NHL-1 trial investigating epcoritamab as monotherapy for 139 patients with R/R DLBCL after two or more lines of systemic therapy. Within the Phase 1/2 NHL-1 clinical trial, the general response rate was 62% (n=86/139), meaning 62% of participants’ blood cancer went down by half or that they had no cancerous cells remaining of their body (partial response or complete response). The entire response rate was 39% (n=54/139), meaning there isn’t any evidence of disease from tests and scans in 39% of those hard-to-treat patients, who on average had already been through three varieties of treatment before starting the trial. The NHL-1 trial results display that epcoritamab prevented growth or spread of the cancer for a median of 15.6 months, and the patients lived for a median of 19.4 months from the beginning of epcoritamab therapy.

AbbVie is committed to advancing take care of people living with blood cancer. Today’s news is a vital step forward in enabling us to supply this hard-to-treat patient group with an revolutionary subcutaneous treatment option. We’re working with the NHS and relevant authorities to bring access to eligible patients and clinicians throughout the UK as quickly as possible.”

Belinda Byrne, Medical Director, AbbVie UK