This approval introduces the first subcutaneous bispecific antibody treatment for this aggressive form of blood cancer in Scotland.
Following the recommendation by the National Institute for Health and Care Excellence (NICE) in March 2024, epcoritamab is now available for use within the NHS across the UK.
DLBCL is a highly aggressive blood cancer affecting approximately 430 adults in Scotland annually. For those whose cancer returns or fails to respond after two treatments, the prognosis is typically poor.
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 setting.
Tepkinly offers new hope by being the first subcutaneous T-cell engaging bispecific antibody available for these patients. It works by connecting the body’s immune T cells to cancerous lymphoma cells, activating the immune system to destroy the cancer cells.
While epcoritamab is given in a hospital setting, it is administered subcutaneously, meaning it is an injection under the skin. This provides a more convenient administration method compared to traditional intravenous treatments, potentially allowing treatment closer to patients' homes.
The approval is based on data from AbbVie’s phase 1/2 EPCORE NHL-1 trial, where epcoritamab showed a 62% overall response rate in patients with relapsed or refractory DLBCL. Notably, 39% of participants achieved a complete response, indicating no detectable cancer.
Josh Hill, scotland policy officer at Blood Cancer UK, expressed optimism about this development, highlighting the anxiety patients feel when their cancer recurs after multiple treatments.
‘We are delighted that the SMC has made epcoritamab available to eligible people in Scotland living with this aggressive blood cancer. Epcoritamab is a bispecific antibody, administered as an injection under the skin, designed to recognise and attach to the cancer cells and immune cells, so that the body’s immune system can destroy them,” he said.
“While most people go into remission after standard treatment, some people can see their cancer returning after each treatment option they try, leaving them feeling unsettled about what the future holds and what the next treatment option will entail.”
Patients will receive epcoritamab weekly for the first 12 weeks, then bi-weekly for the next 24 weeks, followed by monthly injections. Initial administration includes pre-medication and a 24-hour hospital stay to monitor for side effects, which commonly include cytokine release syndrome, fatigue, and injection-site reactions.
In clinical trials, epcoritamab extended the period without cancer progression to an average of 15.6 months, with patients living an average of 19.4 months from the start of therapy.
Dr. Angus Broom, consultant haematologist from the Western General Hospital in Edinburgh, commented: "Adults with DLBCL who have already been through two treatment options, but whose cancer has returned or has not responded, face limited alternative treatment options.
"It is important for physicians to have multiple treatment options, including products with different mechanisms of action and modes of administration, to provide patients with the choice of a treatment that is right for them. That’s why today’s approval is welcomed news for clinicians and eligible DLBCL patients.
"Epcoritamab is the first bispecific treatment option in this disease area that can be administered as an injection under the skin, in a hospital setting. This could allow patients to potentially be treated close to home, as this treatment can be delivered in a wider hospital setting rather than just specialist centres."
Rachael Millward, Medical Director at AbbVie UK, underscored AbbVie’s dedication to improving care for relapsed/refractory DLBCL patients.
"Knowing that relapsed or refractory patients with DLBCL have limited treatment options, and the impact this may have on both their prognosis, mental wellbeing, and quality of life, drives us at AbbVie to advance standards of care. Today’s SMC decision is a result of our commitment to bring innovation to relapsed/refractory DLBCL patients and their loved ones," she said.
With Tepkinly, Scottish patients with this aggressive blood cancer now have access to a pioneering treatment that not only targets the disease effectively but also offers a more patient-friendly administration method.