Tepkinly

Tepkinly is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. A conditional marketing authorization was requested for this new active substance. The submission date for marketing authorization was 6 October 2022, following an orphan medicinal product designation on 24 February 2022.

In efficacy findings, the Overall Response Rate (ORR) for Epcoritamab 48mg (Cohort 2b Dose expansion part) was 97.6%, with a Complete Response (CR) rate of 86.9%. For Epcoritamab 48 mg + R2 (Expansion Part), the ORR was 96.3% and the CR rate was 88.0%. The estimated percentage of subjects remaining in response at 12 months was 84.1%, and at 24 months was 75.6%. The median duration of response (DoR) was 15.5 months.

Regarding safety, the overall incidence of Cytokine Release Syndrome (CRS) was 50.3%, with Grade 1 CRS at 31.1%, Grade 2 CRS at 16.8%, and Grade 3 CRS at 2.4%. Serious infections occurred in 26.5% of subjects. In the LBCL cohort, 67.5% of subjects discontinued study treatment, with 52.9% discontinuing due to progressive disease and 7.0% due to adverse events.