This promotional website is for UK Healthcare Professionals involved in the management of haematological malignancies. Adverse event reporting information can be found below.
I
Tepkinly is licensed
for 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.1
Tepkinly has a conditional marketing authorisation
- further data awaited.
You are advised to read the Prescribing Information and Summary of Product Characteristics, accessible via the links above, to evaluate patient suitability for Tepkinly.
Adverse event reporting information can be found at the bottom of this page.
Tepkinly is licensed for 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.1
Tepkinly has a conditional marketing authorisation
- further data awaited.
You are advised to read the Prescribing Information and Summary of Product Characteristics, accessible via the links above, to evaluate patient suitability for Tepkinly.
Adverse event reporting information can be found at the bottom of this page.
EPCORETM NHL-1
EPCORETM NHL-1 was an open-label, multicohort, multicentre, single-arm, phase 2 (dose expansion) trial that evaluated Tepkinly as monotherapy in 139 patients with CD20-expressing DLBCL, after two or more lines of systemic therapy.1*
Demographics and baseline characteristics of patients with DLBCL in EPCORETM NHL-11
Treatment history in patients with DLBCL in EPCORETM NHL-11
Efficacy results from the EPCORETM NHL-1 study1
The median follow-up time was 15.7 months (range: 0.3-23.5)
Overall response rate (primary endpoint)1
ORR is based on Lugano Criteria (2014) as assessed by Independent Review Committee
Complete response and median duration of response (secondary endpoints)1
Median time to CR was 2.6 months (1.2-10.2)1
− mDOR (CR and PR) in patients who achieved a CR was 17.3 months (95% CI, 15.6-NR) vs. 2.1 months (95% CI, 1.4-3.1) for those who achieved a PR1
Updated efficacy results from the EPCORETM NHL-1 study:
2-year follow-up4
- Median follow-up time: 25.5 months (95% CI, 24.4-26.1)
- mDOR: 17.3 months (95% Cl, 9.7-26.5)
Median time to CR was 2.6 months (range: 1.2-23.2)
Estimated patients with CR remaining in CR at 12 months: 77.4% (95% CI, 62.9–86.8) (N=56)
Estimated patients with CR remaining in CR at 24 months: 61.8% (95% CI, 44.9–74.9) (N=56)
Overall survival (secondary endpoint)3,4
The mOS was 19.4 months (95% CI, 11.7-NR) among DLBCL patients at the 20-month follow-up3
Overall survival of patients with DLBCL (median follow-up: 20 months)3
Tepkinly has a generally manageable safety profile1
The safety of epcoritamab was evaluated in a non-randomised, single-arm study in 167 patients with relapsed or refractory LBCL after two or more lines of systemic therapy, and included all the patients who enrolled to the 48 mg dose and received at least one dose of epcoritamab.
The following adverse reactions have been reported with epcoritamab during clinical studies and post-marketing experience.
Adverse reactions reported in patients in EPCORE™ NHL-11
Adverse reactions for Tepkinly from clinical studies are listed by MedDRA system organ class and are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000).
*EPCORE™ NHL-1 enrolled patients with ECOG status 0-2, de novo DLBCL, DLBCL transformed from indolent lymphoma, CAR-T naïve, prior CAR-T, and primary refractory disease.
†Patients who had relapsed or were refractory to prior CAR-T cell therapy were eligible if ≥30 days since last CAR-T cell treatment.
‡ORR was determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC)
§A patient is considered to be primary refractory if they are refractory to frontline anti-lymphoma therapy.
||A patient is considered to be refractory if they experience disease progression or stable disease as best response or disease progression within 6 months after therapy completion.
aPneumonia includes COVID-19 pneumonia and pneumonia.
bUpper respiratory tract infection includes laryngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, and upper respiratory tract infection.
cNeutropenia includes neutropenia and neutrophil count decreased.
dAnaemia includes anaemia and serum ferritin decreased.
eThrombocytopenia includes platelet count decreased and thrombocytopenia.
fCRS and ICANS events were graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
gTumour Lysis Syndrome was graded based on Cairo-Bishop.
hAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.
iRash includes rash, rash erythematous, rash maculo-papular, and rash pustular.
jFatigue includes asthenia, fatigue, and lethargy.
kInjection site reactions include injection site bruising, injection site erythema, injection site hypertrophy, injection site inflammation, injection site mass, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling, and injection site urticaria.
lPyrexia includes body temperature increased and pyrexia.
mOedema includes face oedema, generalized oedema, oedema, oedema peripheral, and peripheral swelling.
Abbreviations
3L+=third-line plus; BsAB; bispecific antibody; CAR-T=chimeric antigen T cell; CD20=cluster of differentiation 20; CI=confidence interval; CNS=central nervous system; CR=complete response; CRS=cytokine release syndrome; DLBCL=diffuse large B-cell lymphoma; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FISH=fluorescence in situ hybridisation; HSCT=haematopoietic stem cell transplantation; ICANS=immune effector cell-associated neurotoxicity syndrome; mAb=monoclonal antibody; mDOCR=median duration of complete response; mDOR=median duration of response; NHL=non-Hodgkin lymphoma; NR=not reached; ORR=overall response rate; OS=overall survival; PR; partial response; R/R=relapsed/refractory; TLS=tumour lysis syndrome.
References
- Tepkinly Summary of Product Characteristics
- Thieblemont C et al. J Clin Oncol. 2022; 41(12): 2238-47.
- Jurczak W et al. EHA 2023 P1118. HemaSphere 2023; 7(S3): 2150-1. (abstract).
- Thieblemont C et al. Leukemia 2024. https://doi.org/10.1038/s41375-024-02410-8.
By clicking the link above, you will leave the AbbVie Pro website and be taken to the eMC PI portal website.
UK-EPCOR-240399. Date of preparation: December 2024.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com
