I
Tepkinly is now
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 now 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 months)3
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 months)1
At 20-month follow-up, mDOCR in patients who achieved complete response was 20.8 months (95% CI, 15.8-NR)4
Tepkinly has a generally manageable safety profile1
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.
aViral infection includes asymptomatic COVID-19, COVID-19, cytomegalovirus infection, cytomegalovirus infection reactivation, gastroenteritis viral, herpes simplex, herpes zoster, and oral herpes.
bPneumonia includes COVID-19 pneumonia and pneumonia.
cUpper respiratory tract infection includes laryngitis, pharyngitis, respiratory syncytial virus infection, rhinitis, rhinovirus infection, and upper respiratory tract infection.
dFungal infection includes candida infection, oesophageal candidiasis, and oral candidiasis.
eSepsis includes bacteraemia, sepsis, and septic shock.
fNeutropenia includes neutropenia and neutrophil count decreased.
gAnaemia includes anaemia and serum ferritin decreased.
hThrombocytopenia includes platelet count decreased and thrombocytopenia.
iLymphopenia includes lymphocyte count decreased and lymphopenia.
jCRS and ICANS adverse reactions were graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
kTumour Lysis Syndrome was graded based on Cairo-Bishop.
lCardiac arrhythmias include bradycardia, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, and tachycardia.
mAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.
nRash includes rash, rash erythematous, rash maculo-papular, and rash pustular.
oMusculoskeletal pain includes back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain, pain in extremity, and spinal pain.
pFatigue includes asthenia, fatigue, and lethargy.
qInjection 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.
rPyrexia includes body temperature increased and pyrexia.
sOedema includes face oedema, generalised oedema, oedema, oedema peripheral, and peripheral swelling.
tBlood sodium decreased includes blood sodium decreased and hyponatraemia.
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.
UK-EPCOR-230169. Date of preparation: March 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 [email protected]
