
cells. Genmab used technology licensed from Medarex Inc. (Medarex) to generate the CD20 antibody forming
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.
First Quarter 2025 Updates
• January: The Japan MHLW approved EPKINLY (epcoritamab) for the treatment of patients with
relapsed or refractory FL who have received two or more lines of therapy.
• February: Epcoritamab-bysp in combination with gemcitabine and oxaliplatin (GemOx) was added to
the National Comprehensive Cancer Network
®
(NCCN
®
) Clinical Practice Guidelines in Oncology
(NCCN Guidelines
®
) for “B-cell Lymphomas” (Version 2.2025) for second-line patients with DLBCL who
are ineligible for transplant as a Category 2A, preferred regimen.
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.
• It 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
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 will lead commercial operational
activities in Japan. Pfizer is leading commercial operational activities in the U.S. and will lead commercial
operational activities in China once approved in connection with the sublicense of its rights to develop and
commercialize tisotumab vedotin in China to Zai Lab. In the U.S. market there is a 50:50 profit split. Effective
January 1, 2025, Genmab and Pfizer agreed to amend the License and Collaboration Agreement and the Joint
Commercialization Agreement for Tivdak, assigning Genmab sole responsibility for the development and
commercialization of Tivdak for second line plus recurrent or metastatic cervical cancer in Europe and all other
regions globally, excluding the United States and the China region. Genmab will record sales for Europe, Japan
and rest of world markets (excluding the United States and the China region), and will provide royalties to Pfizer
on net sales in the low teens. The companies have joint decision-making power on the worldwide development
and commercialization strategy for Tivdak. Please consult the U.S. Prescribing Information and the European
Summary of Product Characteristics for the labeled indication and safety information for Tivdak.
First Quarter 2025 Updates
• January: Genmab and Pfizer agreed to amend the License and Collaboration Agreement and the Joint
Commercialization Agreement for Tivdak, assigning Genmab sole responsibility for the development
Interim Report for the First Three Months of 2025
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby, Denmark
Tel: +45 7020 2728
www.genmab.com
Company Announcement no. 25
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CVR no. 2102 3884