Genmab — Regulatory Filings 2017

Aug 24, 2017

Company Announcement

-- Phase III ALCYONE study of daratumumab in combination with bortezomib,
melphalan and prednisone (VMP) in front line multiple myeloma met the
primary endpoint at a pre-planned interim analysis
-- Independent Data Monitoring Committee recommends unblinding the data
-- Data will be discussed with health authorities to prepare for regulatory
filings

Copenhagen, Denmark; August 24, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN)
announced today topline results from the Phase III ALCYONE study (MMY3007) of
daratumumab in combination with bortezomib, melphalan and prednisone (VMP)
versus VMP alone as front line treatment for newly diagnosed patients who are
not considered candidates for autologous stem cell transplantation (ASCT). The
study met the primary endpoint of improving progression free survival (PFS) at
a pre-planned interim analysis (Hazard Ratio (HR) = 0.50 (95% CI 0.38-0.65), p
< 0.0001). Treatment with daratumumab reduced the risk of disease progression
or death by 50%, as compared to those who did not receive daratumumab. The
median PFS for patients treated with daratumumab in combination with VMP has
not been reached, compared to an estimated median PFS of 18.1 months for
patients who received VMP alone.

Overall, the safety profile of daratumumab in combination with VMP is
consistent with the known safety profile of the VMP regimen and the known
safety profile of daratumumab.

Based on the results at the pre-planned interim analysis conducted by an
Independent Data Monitoring Committee (IDMC), it was recommended that the data
be unblinded. All patients will continue to be monitored for safety and overall
survival. Further analysis of the safety and efficacy data is underway and
Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, will
discuss with health authorities the potential for a regulatory submission for
this indication. The data are expected to be submitted for presentation at an
upcoming medical conference and for publication in a peer-reviewed journal.

“The interim results of the ALCYONE study yet again illustrate the potential of
daratumumab in multiple myeloma in combination with existing treatment
regimens; this time with VMP in the front line setting. We are very pleased
with the outcome of the pre-planned interim analysis in this study, which adds
further to our hope that daratumumab could potentially become the critical
driver redefining combination treatment in multiple myeloma,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.

Today’s news does not impact Genmab’s 2017 financial guidance.

About the study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter
study and includes 706 newly diagnosed patients with multiple myeloma who are
ineligible for autologous stem cell transplantation (ASCT). Patients were
randomized to receive 9 cycles of either daratumumab combined with VMP
[bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic
agent) and prednisone (a corticosteroid)], or VMP alone. In the daratumumab
treatment arm, patients received 16 mg/kg of daratumumab once weekly for six
weeks (cycle 1; 1 cycle = 42 days), followed by once every three weeks (cycles
2-9). Following the 9 cycles, patients in the daratumumab treatment arm
continued to receive 16 mg/kg of daratumumab once every four weeks until
disease progression. The primary endpoint of the study is progression free
survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow
and is characterized by an excess proliferation of plasma cells.1 Multiple
myeloma is the third most common blood cancer in the U.S., after leukemia and
lymphoma.2 Approximately 30,330 new patients were expected to be diagnosed with
multiple myeloma and approximately 12,650 people were expected to die from the
disease in the U.S. in 2016.3 Globally, it was estimated that 124,225 people
would be diagnosed and 87,084 would die from the disease in 2015.4 While some
patients with multiple myeloma have no symptoms at all, most patients are
diagnosed due to symptoms which can include bone problems, low blood counts,
calcium elevation, kidney problems or infections.5 Patients who relapse after
treatment with standard therapies, including proteasome inhibitors or
immunomodulatory agents, have poor prognoses and few treatment options.6

About DARZALEX® (daratumumab)
DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the
United States in combination with lenalidomide and dexamethasone, or bortezomib
and dexamethasone, for the treatment of patients with multiple myeloma who have
received at least one prior therapy; in combination with pomalidomide and
dexamethasone for the treatment of patients with multiple myeloma who have
received at least two prior therapies, including lenalidomide and a proteasome
inhibitor (PI); and as a monotherapy for the treatment of patients with
multiple myeloma who have received at least three prior lines of therapy,
including a PI and an immunomodulatory agent, or who are double-refractory to a
PI and an immunomodulatory agent.7 DARZALEX is the first monoclonal antibody
(mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat
multiple myeloma. DARZALEX is indicated in Europe for use in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the
treatment of adult patients with multiple myeloma who have received at least
one prior therapy and as monotherapy for the treatment of adult patients with
relapsed and refractory multiple myeloma, whose prior therapy included a PI and
an immunomodulatory agent and who have demonstrated disease progression on the
last therapy. DARZALEX is the first human CD38 monoclonal antibody approved in
Europe. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high
affinity to the CD38 molecule, which is highly expressed on the surface of
multiple myeloma cells. Daratumumab triggers a person’s own immune system to
attack the cancer cells, resulting in rapid tumor cell death through multiple
immune-mediated mechanisms of action and through immunomodulatory effects, in
addition to direct tumor cell death, via apoptosis (programmed cell death).
7,8,9,10,11

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive
worldwide license to develop, manufacture and commercialize daratumumab from
Genmab. Five Phase III clinical studies with daratumumab in relapsed and
frontline multiple myeloma settings are currently ongoing, and additional
studies are ongoing or planned to assess its potential in other malignant and
pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma,
NKT-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors.
Daratumumab has received two Breakthrough Therapy Designations from the U.S.
FDA, for multiple myeloma, as both a monotherapy and in combination with other
therapies.

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.

References
1 American Cancer Society. "Multiple Myeloma Overview." Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what
-is-multiple-myeloma.Accessed
June 2016.
2 National Cancer Institute. "A Snapshot of Myeloma." Available at
www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016.
3 American Cancer Society. "What are the key statistics about multiple
myeloma?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-
statistics.
Accessed June 2016.
4 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence
Worldwide: Number of New Cancers in 2015. Available at:
http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selecti
on_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Exe
cute.
Accessed June 2016.
5 American Cancer Society. "How is Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diag
nosis.
Accessed June 2016.
6 Kumar, SK et al. Risk of progression and survival in multiple myeloma
relapsing after last therapy with IMiDs and bortezomib: a multicenter
international myeloma working group study. Leukemia. 2012; 26:149-57.
7 DARZALEX Prescribing information, June 2017. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf.
Last accessed June 2017.
8 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal
Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors.
The Journal of Immunology. 2011; 186: 1840-1848.
9 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the
anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.
10 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells,
Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma.
Blood. 2016; 128: 384-94.
11 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of
myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;
120(21): abstract 2974.

Company Announcement no. 28
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark