AbbVie has announced that Tepkinly (epcoritamab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adults with diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer.
Patients eligible for the CD20xCD3 bispecific antibody, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, will have DLBCL that has returned or not responded to at least two prior treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this is contraindicated or not tolerated.
Approximately 5,500 new cases of DLBCL are diagnosed in the UK every year and, for around 700 of these patients whose cancer has returned or not responded to at least two prior treatments, the prognosis is poor and treatment options are limited.
Tepkinly is now the first injectable bispecific treatment option to be approved for this patient population and is given in hospital as a once-weekly subcutaneous injection for 12 weeks, then every other week for 24 weeks, before continuing as one injection every 4 weeks until treatment is discontinued due to cancer progression or side effects.
Belinda Byrne, medical director at AbbVie UK, said: “We are delighted that NICE has recognised the benefit that [Tepkinly] can have on the lives of people living with relapsed or refractory DLBCL.
“We will continue working closely with the relevant authorities to provide equitable access across the UK for eligible… patients in need.”
NICE’s decision was supported by positive results from the phase 1/2 EPCORE NHL-1 trial, in which Tepkinly delivered an overall response rate of 62% and a complete response rate of 39%.
“Despite recent therapeutic advances, treatment options for this hard-to-treat group of patients have been limited,” said Chris Fox, professor of haematology, School of Medicine, University of Nottingham and honorary consultant haematologist, Nottingham University Hospitals NHS Trust. “This can mean many patients do not have suitably effective treatment options, resulting in a poor prognosis.”
“The decision by NICE will be welcomed by both patients and the clinical community,” he added.
Both AbbVie and Genmab will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialisation.