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THE [SINGLE-AGENT] EFFICACY, MANAGEABLE SAFETY, AND QUICK SUBCUTANEOUS ADMINISTRATION DEMONSTRATED IN 3L+ DLBCL. [NOW] APPROVED IN 3L+ FL.1,2

[Deep and durable responses in 3L+ DLBCL and 3L+ FL1,3,4]

 

[Evaluated in patients with and without high-risk features1,3-7]

3L+ DLBCL

[TEPKINLY] as monotherapy 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.

Overall results:

• 62% ORR with a 39% CR* [mOS of 19.4 months]
• mDOR 15.5 months

Included the following subgroups:

• Post–CAR T
• CAR-T naïve
• Primary refractory

3L+ FL

[TEPKINLY] is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Overall results:

• 82% ORR with a 63% CR§
• mDOR not reached

Included the following subgroups:

• Double refractory
• POD24
• FLIPI 3+

*Overall response (ORR) and complete response (CR) rates were 62% (95% CI, 53.3-70) and 39% (95% CI, 30.7-47.5), respectively.1

[Overall survival (OS) was a secondary endpoint in the study. After a median follow-up time of 20 months (range: 0.3+-28.2), the median OS for patient on [TEPKINLY] was 19.4 months (11.7-NR).2,3]

Median duration of response (mDOR) was 15.5 months (95% CI, 9.7-NR).1

§Overall response rates (ORR) and complete response (CR) rates were 82% (95% CI,74.3-88.3) and 63% (95% CI, 53.5-70.9).1

Median duration of response (mDOR) was NR (95% CI, 13.7-NR).1

3L+=third-line plus; bsAb=bispecific antibody; CAR T=chimeric antigen T cell; CD3=cluster of differentiation 3; CD20=cluster of differentiation 20; CI=confidence interval; CR=complete response; DLBCL=diffuse large B-cell lymphoma; FL=follicular lymphoma; FLIPI=Follicular Lymphoma International Prognostic Index; mDOR=median duration of response; mOS=median overall survival; NR=not reached; ORR=overall response rate; POD24=progression of disease within 24 months of first treatment.

[▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.]

[This medicinal product has been authorised under a 'condition approval'. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product frequently and the SmPC will be updated as necessary.]

Please see the [TEPKINLY] SmPC for Full Prescribing and Safety Information.

[INCLUDE SAFETY INFORMATION PER LOCAL REGULATIONS]

 

References: 1. [TEPKINLY] Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland; [2023]. 2. Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell–engaging antibody, in relapsed or refractory large B-call lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. 2023;41(12):2238-2247. doi:10.1200/jco.22.01725 3. Jurczak W, Ghesquieres H, Karimi Y, et al. P1118: longer follow-up from the pivotal EPCORE NHL-1 trial reaffirms subcutaneous epcoritamab induces deep, durable complete remissions in patients with relapsed/refractory large B-cell lymphoma. Hemasphere. 2023;7(Suppl):e081065c. doi:10.1097/01.HS9.0000971368.08106.5c 4. Linton KM, Jurczak W, Lugtenburg P. et al. Epcoritamab SC monotherapy leads to deep and durable responses in patients with relapsed or refractory follicular lymphoma: first data disclosure from the EPCORE NHL-1 Follicular Lymphoma dose-expansion cohort. Poster presented at: 65th American Society of Hematology Annual Meeting and Exposition; December 9-12, 2023; San Diego, CA. 5. Duarte C, Kamdar M. Management considerations for patients with primary refractory and early relapsed diffuse large B-cell lymphoma. Am Soc Clin Oncol Educ Book. 2023;43(43):e390802. doi:10.1200/EDBK_390802 6. Di Blasi R, Le Gouill S, Bachy E, et al. Outcomes of patients with aggressive B-cell lymphoma after failure of anti-CD19 CAR T-cell therapy: a DESCAR-T analysis. Blood. 2022;140(24):2584-2593. doi:10.1182/blood.2022016945 7. Patel AA, Smith SM. Clinical and biological prognostic factors in follicular lymphoma. Hematol Oncol Clin North Am. 2020;34(4):647-662. doi:10.1016/j. hoc.2020.02.002

ALL-EPCOR-230075