part of epcoritamab. Epcoritamab is marketed as EPKINLY in the U.S., Japan, and other regions, and as
TEPKINLY in Europe and other regions. See local prescribing information for specific indications and safety
information. In 2020, Genmab entered into a collaboration agreement with AbbVie to jointly develop and
commercialize epcoritamab. The companies share commercialization responsibilities in the U.S. and Japan,
with AbbVie responsible for further global commercialization.
Genmab records sales in the U.S. and Japan and receives tiered royalties between 22% and 26% on remaining
global sales outside of these territories, subject to certain royalty reductions. The companies have a broad
clinical development program for epcoritamab including five ongoing Phase 3 trials and additional trials in
planning. Please consult the U.S. Prescribing Information for EPKINLY and the European Summary of Product
Characteristics for TEPKINLY for the labeled indication and safety information.
Second Quarter 2025 Updates
• May: Submission of a sBLA to the FDA for SC epcoritamab in combination with R2 for the treatment of
adult patients with relapsed or refractory FL, following at least one prior systemic therapy. The
submission is supported by positive topline results from the Phase 3 EPCORE® FL-1 (NCT05409066)
trial.
• June: Results from an analysis of the Phase 1/2 EPCORE NHL-1 study of epcoritamab, including long-
term follow-up in adult patients with relapsed/refractory DLBCL who remain in complete response (CR)
at two years, were presented at the 2025 ASCO Annual Meeting.
• June: Fourteen abstracts evaluating epcoritamab both as a monotherapy and in combination across
disease settings in patients with DLBCL and FL were presented at the 30th European Hematology
Association (EHA) Congress. Two oral presentations featured data from the Phase 1/2 EPCORE NHL-2
(NCT04663347) trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-
ICE) in patients with relapsed/refractory DLBCL eligible for autologous stem cell transplantation, and the
Phase 1/2 EPCORE NHL-5 (NCT05283720) trial evaluating epcoritamab plus polatuzumab vedotin,
rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated
patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 (NCT03625037) and
NHL-3 (NCT04542824) trials, including three years of follow-up in patients with relapsed/refractory
DLBCL and FL treated with epcoritamab monotherapy, were presented as posters.
• June: Twenty-eight data presentations, including one oral presentation, were featured at the 18th
International Conference on Malignant Lymphoma (ICML).
Tivdak (tisotumab vedotin) – First and only ADC for recurrent or metastatic cervical cancer in the U.S.,
Europe and Japan
• An ADC directed to TF, a protein highly prevalent in solid tumors, including cervical cancer, which is
associated with poor prognosis
• Tisotumab vedotin, approved as Tivdak, is the first and only ADC approved in the U.S., Europe and
Japan for the treatment of recurrent or metastatic cervical cancer after prior therapy and is the only ADC
with demonstrated overall survival data in this setting compared to chemotherapy
• Co-developed globally and co-promoted in the U.S. in collaboration with Pfizer, exclusively by Genmab
outside of the U.S. and China
Tisotumab vedotin is an ADC composed of Genmab’s human monoclonal antibody directed to TF and Pfizer’s
ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting
agent monomethyl auristatin E to the antibody. Genmab used technology licensed from Medarex to generate
the TF antibody forming part of tisotumab vedotin. Tisotumab vedotin, marketed as Tivdak, is the first and only
ADC approved for the treatment of adult patients with recurrent or metastatic cervical cancer after prior therapy
in the U.S., Europe and Japan. Tisotumab vedotin is being co-developed by Genmab and Pfizer. Under a joint
commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and is leading commercial
operational activities in Japan, Europe and all other regions globally, excluding the United States and the China
region. Pfizer is leading commercial operational activities in the U.S. and will lead commercial operational
