AbbVie’s Tepkinly for Lymphoma Patients Approved by NICE

The National Institute for Health and Care Excellence (NICE) has given its approval for the use of AbbVie’s CD20xCD3 bispecific antibody, Tepkinly (epcoritamab), within the National Health Service (NHS) in England as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). DLBCL is a particularly aggressive and rapidly progressing form of non-Hodgkin lymphoma.

Tepkinly’s approval marks a significant milestone as it becomes the first injectable CD20xCD3 bispecific antibody to gain approval for this specific patient group. This recommendation by NICE follows the drug’s emergence from AbbVie’s $3.9 billion partnership with Genmab, a collaboration that was established in 2020. The approval of Tepkinly offers a subcutaneously administered treatment option, differentiating it from Roche’s intravenous infusion, Columvi (glofitamab), which was similarly recommended by NICE for this patient population in October of the previous year.

Tepkinly’s Subcutaneous Administration Sets It Apart from Roche’s Columvi for Lymphoma Patients

Tepkinly, administered via a subcutaneous injection, is typically given once weekly for 12 weeks. Subsequently, the dosing frequency decreases to once every two weeks and finally to once monthly until either the treatment is discontinued due to cancer progression or as a result of side effects. Patients eligible for Tepkinly treatment should have received prior treatment with Seagen and Astellas’ Nectin4-directed antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) unless contraindicated.

In contrast, Roche’s Columvi offers a fixed duration of treatment consisting of 12 cycles administered over approximately 8.5 months. This approach may appeal to patients who prefer having a specific target completion date, as well as to healthcare payers who are dealing with a predetermined cost of treatment. Professor Chris Fox, a hematology specialist at Nottingham University Hospitals NHS Trust, highlighted the significance of Tepkinly’s subcutaneous route of administration, suggesting that it may aid in capacity planning within lymphoma services.

Both Tepkinly and Columvi are introduced as more straightforward alternatives to third-line CAR-T therapies for diffuse large B-cell lymphoma, such as Novartis’ Kymriah (tisagenlecleucel), Gilead Sciences’ Yescarta (axicabtagene ciloleucel), and Breyanzi (lisocabtagene maraleucel). These CAR-T therapies often involve complex manufacturing and administration processes and require in-hospital care. DLBCL is a condition that affects nearly 5,500 individuals in the UK annually. Within this population, approximately 700 patients experience cancer recurrence or show resistance to at least two previous treatment regimens. Unfortunately, the prognosis for this group of patients is particularly grim, according to AbbVie.

Tepkinly’s Approval Backed by Impressive EPCORE Study Results

The approval of Tepkinly, also known as Epkinly in some markets, was based on data from the phase 1/2 EPCORE study. The study demonstrated an overall response rate of 62% with Tepkinly, including a remarkable 39% rate of complete responses, indicating the absence of detectable disease in testing. Rincy George, a policy officer at the patient organization Blood Cancer UK, expressed support for NICE’s decision, emphasizing the anxiety experienced by individuals with relapsed or refractory DLBCL regarding treatment outcomes.

Analysts at Jefferies had previously projected that AbbVie and Genmab’s drug could potentially generate up to $2.75 billion in peak sales. If achieved, this revenue would help AbbVie offset some of the impact of biosimilar competition affecting its blockbuster immunology drug, Humira (adalimumab). The approval of Tepkinly represents a significant step forward in improving treatment options for DLBCL patients and offers hope for better outcomes in the battle against this aggressive form of lymphoma.