Julie Blaedel from Genmab and Michael Moran from AbbVie Discuss the Conditional EC Approval of TEPKINLY in a Stimulating Conversation with PharmaShots

Shots:

Diffuse large B-cell lymphoma remains the most common type of non-Hodgkin lymphoma. With limited therapeutic options for patients whose disease gets relapsed or refractory, AbbVie and Genmab’s TEPKINLY is one-of-a-kind monotherapy for adult patients with relapsed or refractory DLBCL
Post EC’s conditional approval, Julie Blaedel & Michael Moran engage in an enlightening conversation with PharmaShots. TEPKINLY is now available in the European Union (EU), as well as in Liechtenstein, Norway, and Iceland
While sharing the highlights from the EPCORE™ NHL-1 P-I/II study, Julie and Michael talk about the conditional approval of TEPKINLY and discuss in great length the prospect of evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies

Saurabh: Can you please elaborate more about TEPKINLY (epcoritamab), and how it works in the treatment of DLBCL?

Julie & Michael: On September 25, 2023, the European Commission (EC) granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway and Iceland.

Saurabh:  Will TEPKINLY be available in all European countries, and how soon can patients access this treatment (if possible, mention which countries first)?

Julie & Michael: We are committed to delivering a safe and effective treatment option for patients as soon as possible.

Saurabh: Shed some light on the clinical trials and studies that led to the approval of TEPKINLY in Europe.

Julie and Michael: TEPKINLY was granted conditional marketing authorization based on data from the pivotal EPCORE™ NHL-1 P-I/II open-label, multi-cohort, multi-center, single-arm trial evaluating the preliminary efficacy and safety of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL. In data submitted to the European Medicines Agency (EMA) as part of the application for approval, DLBCL patients treated with TEPKINLY (N=139) achieved an overall response (OR) rate of 62 percent and a complete response (CR) rate of 39 percent. The median duration of response was 15.5 months (range: 9.7, not reached). Since these data were submitted to the EMA, updated data from the EPCORE NHL-1 P-I/II clinical trial have been presented at medical meetings.

Results from the EMA data submission showed that TEPKINLY demonstrated a manageable safety profile across the LBCL patient cohort (N=167), which included the DLBCL patient population. The most common adverse reactions (≥20 percent) were cytokine release syndrome, fatigue, neutropenia, injection site reaction, musculoskeletal pain, abdominal pain, pyrexia, nausea and diarrhea.

Saurabh: Give a brief of long-term outcomes for DLBCL patients receiving TEPKINLY.

Julie & Michael: We previously shared updated data from the EPCORE™ NHL-1 expansion cohort at the European Haematology Association Annual Meeting 2023. These data included longer follow-ups (median follow-up was 20 months) in challenging-to-treat, relapsed or refractory CD20+ LBCL patients. Of the 157 patients with R/R LBCL, including DLBCL and high-grade B-cell lymphoma (HGBCL) (n=148), Primary mediastinal large B-cell lymphoma (PMBCL [n=4]), and FL (n=5), Results from the trial showed an OR of 63.1 percent and CR of 39.5 percent in patients with R/R LBCL and a 61.9 percent OR and 39.6 percent CR in patients with R/R DLBCL. The median overall survival (OS) was 18.5 months for LBCL patients and 19.4 months for DLBCL patients. The median duration of CR in both patient populations was 20.8 months. OS was not reached among complete responders in both patient populations.

Studies are ongoing, and we will continue to report longer-term data as available.

Saurabh: Is there any ongoing studies or research into TEPKINLY for other cancer indications or potential combination therapies?

Julie & Michael: Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing P-III, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494) compared to investigators choice chemotherapy, a P-III, trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a P-III, open-label clinical trial evaluating epcoritamab in combination in patients with R/R follicular lymphoma (FL) (NCT: 05409066). The safety and efficacy of epcoritamab has not been established for these investigational uses.

AbbVie and Genmab are committed to transforming standards of care across blood cancers and advancing a dynamic pipeline and accelerating the future of oncology. We are dedicated to the treatment and management of multiple hematologic malignancies with our first-in-class medicines, enabling patients to live longer without disease progression.

Image Source: Canva

About the Author:

Michael Moran

Michael Moran is responsible for global medical affairs strategy across a range of lymphoid malignancies at AbbVie, with main areas of focus on chronic lymphocytic leukemia and non-Hodgkin's lymphoma. He is a medical affairs physician with clinical and postdoctoral research experience in molecular oncology and aims to foster innovation in his work – specifically in evidence generation and digital health activities. Michael graduated from Queen’s University Belfast with a medical degree including a Bachelor of Science in Therapeutics and Pharmacology, a Master of Medical Science in Medical Education and a PhD in Molecular Oncology.

Julie Blaedel

Julie Blaedel is the Vice President, Head of Global Medical Affairs Strategy Lead at Genmab. Prior to joining Genmab, she was the Medical Director, US Medical Lead/Manager, Oncology/Hematology at Amgen. She has commercial, medical affairs and clinical development experience within oncology and hematology and has also previously worked at GSK and Pfizer. Julie received her medical degree from Copenhagen University.