Company Announcement
- Preliminary data shows responses achieved in 11 of 34 evaluable patients with cervical cancer
treated with tisotumab vedotin
- Next steps in clinical development of tisotumab vedotin in this indication under active
consideration
Copenhagen, Denmark; June 16, 2017 – Genmab A/S (Nasdaq
Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors
(GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort
achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression.
The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjugates (ADC), including peripheral
neuropathy and neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin specific toxicity, which led to
introducing of prophylactic management. In the cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse events:
gastro-intestinal related (5 patients), anemia (2 patients), infections (1 patient), neuropathy (2 patients), bleeding (2
patients), other (10 patients). Genmab is considering plans for further clinical development of tisotumab vedotin in cervical
cancer. The GEN701 study is ongoing and further data in both cervical cancer and other solid tumor indications will be published at
a later date.
“The preliminary data we see in patients with cervical cancer treated with tisotumab vedotin are
encouraging. We believe further development of this novel antibody-drug conjugate may be warranted in cervical cancer and are
actively looking into possible next steps,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Genmab intends to submit data from this study for presentation at an upcoming medical conference.
About the GEN701 study
The GEN701 study is a 173 patient, two-part Phase I/II study of tisotumab vedotin in seven types of solid tumors:
ovarian, cervical, endometrium, bladder, prostate, esophageal, and lung. Part 1 was a classical 3+3 dose escalation design
testing various doses of tisotumab vedotin once every three weeks to establish the recommended Phase II (RP2D) and maximum
tolerated dose as well as the safety profile of tisotumab vedotin. The still ongoing Part 2 of the study investigates all
seven indications in parallel expansion cohorts. Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three
weeks. The primary objective of this part of the study is to further investigate the safety profile of tisotumab vedotin and
preliminary efficacy.
About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human antibody that binds to tissue factor
(TF) conjugated to Seattle Genetics’ clinically validated cytotoxic drug MMAE. TF is a protein involved in tumor signaling
and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for
an ADC approach. Tisotumab vedotin is in Phase I/II clinical development for solid tumors in two studies (GEN701 and GEN702).
Genmab has a license and collaboration agreement for tisotumab vedotin with Seattle Genetics under which Seattle Genetics has
the right to exercise a co-development option at the end of Phase I clinical development.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of
differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies,
DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab)
for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional
multiple myeloma indications, other blood cancers, and solid tumors. A subcutaneous formulation of ofatumumab is in
development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline.
Genmab's technology base consists of validated and proprietary next generation antibody technologies - the
DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector
function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or
co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more
information visit
www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”,
“intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such statements. The important factors that could cause
our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical
development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the
competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified
personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated
entities, changes and developments in technology which may render our products obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake
any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in
relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab
logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™;
HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra®
is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
Company Announcement no. 22
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
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http://www.globenewswire.com/NewsRoom/AttachmentNg/90a9331c-7c70-49ca-8dda-439fd7a5cf14
