This promotional website is for NI Haemato-Oncology Healthcare Professionals only. 

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.


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


Tepkinly has a generally manageable safety profile2

Adverse reactions reported in patients in EPCORE™ NHL-1

For full safety information, please refer to the NI SmPC (www.emcmedicines.com/en-gb/northernireland/)

 

*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.
aClassified using MedDRA version 24.1. CRS events and ICANS events were graded per Lee et al; clinical tumor lysis syndrome was graded per Cairo-Bishop criteria. All other events were graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.4,5
b24 patients had CRS that was a maximum of grade 2 in severity; of these, 19 patients had hypotension, including 6 with concurrent hypoxia and 13 without concurrent hypoxia, and did not receive vasopressor treatment.
cPyrexia not considered CRS by the investigator.
dOne fatal case of ICANS was reported.


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; MedDRA=Medical Dictionary for Regulatory Activities; 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

  1. Tepkinly NI Summary of Product Characteristics.
  2. Thieblemont C et al. J Clin Oncol. 2022; 41(12): 2238-47.
  3. European Medicines Agency. Assessment report. July 2023. EMEA/H/C/005985/0000. Available at: https://www.ema.europa.eu/en/documents/assessment-report/tepkinly-epar-public-assessment-report_en.pdf. (Accessed October 2024). 
  4. Lee D et al. Biol Blood Marrow Transplant. 2019; 25(4): 625-38. 
  5. Coiffier B et al. J Clin Oncol. 2008; 26(16): 2767-78.

References

  1. Tepkinly NI Summary of Product Characteristics.
  2. Thieblemont C et al. J Clin Oncol. 2022; 41(12): 2238-47.
  3. European Medicines Agency. Assessment report. July 2023. EMEA/H/C/005985/0000. Available at: https://www.ema.europa.eu/en/ documents/assessment-report/tepkinly-epar-public-assessment-report_en.pdf. (Accessed October 2024). 
  4. Lee D et al. Biol Blood Marrow Transplant. 2019; 25(4): 625-38. 
  5. Coiffier B et al. J Clin Oncol. 2008; 26(16): 2767-78.

UK-EPCOR-240324. Date of preparation: October 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