Company Announcement
- Interim analysis of PROLONG study met primary
endpoint
- Further analysis of safety and efficacy data
underway
- Interim analysis to be shared with regulatory agencies
to evaluate the potential for future regulatory
filings
GlaxoSmithKline plc (LSE/NYSE: GSK) and Genmab A/S
(Copenhagen:GEN) announced today that an Independent Data
Monitoring Committee (IDMC) interim analysis of a Phase III study,
PROLONG (OMB 112517), reached the predefined significance level for
efficacy (p<=0.001). The interim analysis
demonstrated that treatment with ofatumumab (Arzerra(tm)) met the
primary endpoint of improving progression free survival (PFS).
The study evaluated ofatumumab maintenance therapy
versus no further treatment (observation) in patients with relapsed
chronic lymphocytic leukemia (CLL) who responded to treatment at
relapse. The IDMC did not identify any new safety signals and will
continue to monitor patients for safety until all study patients
complete therapy. Further analysis of the safety and efficacy data
is underway and will be shared with regulators and the scientific
community in the coming months. "This interim result from the
PROLONG study demonstrated that maintenance therapy with ofatumumab
lowered the risk of disease progression in patients who responded
to treatment at relapse. We look forward to sharing the
results of the interim analysis with regulatory agencies to
evaluate the potential for future regulatory filings," said Dr.
Rafael Amado, Head of Oncology R&D, GSK. "We are very pleased
that this study of ofatumumab, the first Phase III study to
evaluate maintenance therapy for relapsed CLL, met the primary
endpoint at the interim analysis. This result indicates the
potential of ofatumumab in this setting where there are currently
no approved treatments. We look forward to presenting the detailed
data from this study at a future medical conference," said Jan van
de Winkel, Ph.D., Chief Executive Officer of Genmab. About
PROLONG This pivotal Phase III study was designed to
randomize up to 532 patients with relapsed CLL who have responded
to treatment at relapse, to either ofatumumab maintenance treatment
or no further treatment (observation). Patients in the ofatumumab
arm receive an initial dose of 300 mg of ofatumumab, followed one
week later by a second dose of 1,000 mg, then doses of 1,000 mg
every 8 weeks for up to two years, while patients in the
observation treatment arm receive no further treatment. The primary
endpoint of the study is PFS. Secondary objectives will evaluate
clinical benefit, safety, tolerability, the health-related quality
of life of subjects treated with ofatumumab versus no further
treatment, and pharmacokinetics among relapsed CLL patients
receiving maintenance therapy with ofatumumab. About
CLL CLL, the most commonly diagnosed adult leukaemia in
western countries, accounts for approximately one-third of all
cases of leukemia.1,2,3 In the USA, it is estimated that more
than 105,000 people currently live with or have been previously
treated for CLL and an estimated 15,680 new cases of CLL were
diagnosed in the past year.3,4 The average age of diagnosis is
72 years, and approximately 90 percent of patients with CLL are
estimated to be over the age of 55 years.3,5 The majority of
patients with CLL have at least one comorbidity such as
hypertension, diabetes, cardiovascular disease, or COPD.6
About ofatumumab (Arzerra) Ofatumumab--a
monoclonal antibody that is designed to target the CD20 molecule
found on the surface of CLL cells and normal B lymphocytes--is not
approved or licensed anywhere in the world as maintenance treatment
for relapsed CLL. In the USA, ofatumumab is approved for use in
combination with chlorambucil for the treatment of previously
untreated patients with CLL for whom fludarabine-based therapy is
considered inappropriate. In the EU, ofatumumab is approved for use
in combination with chlorambucil or bendamustine for the treatment
of patients with CLL who have not received prior therapy and who
are not eligible for fludarabine-based therapy. Ofatumumab is also
approved for first-line use in Russia. In more than 50 countries
worldwide, ofatumumab is indicated as monotherapy for the treatment
of patients with CLL refractory to fludarabine and alemtuzumab.
Ofatumumab is being developed under a co-development and
collaboration agreement between Genmab and GSK. Arzerra is a
trademark of the GSK group of companies. Important Safety
Information for ofatumumab (Arzerra) The overall safety
profile of ofatumumab in CLL (previously untreated and relapsed or
refractory) is based on data from more than 500 patients treated
alone or in combination with other therapies in clinical trials.
The most common undesirable effects for ofatumumab include adverse
events associated with infusion reactions, cytopenias (neutropenia,
anemia, febrile neutropenia, thrombocytopenia, leukopenia) and
infections (lower respiratory tract infection, including pneumonia,
upper respiratory tract infection, sepsis, including neutropenic
sepsis and septic shock, herpes virus infection, urinary tract
infection). Contraindications: Hypersensitivity to
ofatumumab or to any of the excipients. Special warnings
and precautions for use of ofatumumab are summarized as
follows: Infusion reactions Ofatumumab
has been associated with infusion reactions. These reactions
may result in temporary interruption or withdrawal of treatment or
death. Pre-medications attenuate infusion reactions but these
may still occur, predominantly during the first infusion.
Infusion reactions may include, but are not limited to,
anaphylactic reactions, bronchospasm, cardiac events (eg myocardial
ischemia / infarction, bradycardia), chills/rigors, cough, cytokine
release syndrome, diarrhea, dyspnoea, fatigue, flushing,
hypertension, hypotension, nausea, pain, pulmonary edema, pruritus,
pyrexia, rash, and urticaria. Even with pre-medication, severe
reactions, including cytokine release syndrome, have been reported
following ofatumumab use. In cases of severe infusion
reaction, the infusion of ofatumumab must be interrupted
immediately and symptomatic treatment instituted (see Dosage and
Administration for changes to infusion rates following infusion
reactions). Infusion reactions occur more frequently on the first
day of infusion and tend to decrease with subsequent
infusions. Patients with a history of decreased pulmonary
function may be at a greater risk for pulmonary complications from
severe reactions and should be monitored closely during infusion of
ofatumumab. Tumor lysis syndrome In patients with
CLL, tumor lysis syndrome (TLS) may occur with use of
ofatumumab. Risk factors for TLS include a high tumor burden,
high concentrations of circulating cells (>= 25,000/mm3),
hypovolemia, renal insufficiency, elevated pre-treatment uric acid
levels and elevated lactate dehydrogenase levels. Management
of TLS includes correction of electrolyte abnormalities, monitoring
of renal function, maintenance of fluid balance and supportive
care. Progressive multifocal leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML) and death has been
reported in CLL patients receiving cytotoxic pharmacotherapy,
including ofatumumab. If a diagnosis of PML is suspected,
ofatumumab should be discontinued and referral to a neurologist
should be considered. Immunizations The safety of,
and ability to generate a primary or anamnestic response to,
immunization with live attenuated or inactivated vaccines during
treatment with ofatumumab has not been studied.
Hepatitis B Hepatitis B virus (HBV) infection
and reactivation, in some cases resulting in fulminant hepatitis,
hepatic failure and death, has occurred in patients treated with
drugs classified as CD20-directed cytolytic antibodies, including
ofatumumab. All patients should be screened for HBV infection
before initiation of ofatumumab treatment, patients previously
exposed to HBV should be followed closely in consultation with an
expert in this disease. Patients with evidence of prior HBV
infection should be monitored for clinical and laboratory signs of
hepatitis or HBV reactivation. Cardiovascular
Patients with a history of cardiac disease should be monitored
closely. Ofatumumab should be discontinued in patients who
experience serious or life-threatening cardiac arrhythmias.
The effect of multiple doses of ofatumumab on the QTc interval
was evaluated in a pooled analysis of three open-label studies in
patients with CLL (N=85). Increases above 5 msec were observed in
the median/mean QT/QTc intervals in the pooled analysis. No
large changes in the mean QTc interval (ie, >20 milliseconds)
were detected. Bowel obstruction Bowel obstruction
has been reported in patients receiving anti-CD20 monoclonal
antibody therapy, including ofatumumab. Patients who present
with abdominal pain, especially early in the course of ofatumumab
therapy, should be evaluated and appropriate treatment instituted.
For the full US Prescribing Information,
including Boxed Warning, visit
https://www.gsksource.com/gskprm/htdocs/documents/ARZERRA.PDF.
For the full EU Summary of Product
Characteristics (SPC) visit
http://health.gsk.com/.
GSK - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com. About Genmab A/S Genmab is a publicly
traded, international biotechnology company specializing in the
creation and development of differentiated human antibody
therapeutics for the treatment of cancer. Founded in 1999,
the company currently has one marketed antibody, Arzerra(tm)
(ofatumumab) for the treatment of certain chronic lymphocytic
leukemia indications, a clinical pipeline with both late and early
stage programs, and an innovative pre-clinical pipeline.
Genmab's technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody(r) platform for
generation of bispecific antibodies, and the HexaBody(tm) platform
which creates effector function enhanced antibodies. Genmab's deep
antibody expertise is expected to provide a stream of future
product candidates. Partnering of selected innovative product
candidates and technologies is a key focus of Genmab's strategy and
the company has alliances with top tier pharmaceutical and
biotechnology companies. For more information visit
www.genmab.com. GSK enquiries:
UK Media enquiries: David
Mawdsley
+44 (0) 20 8047 5502
(London) Simon
Steel
+44 (0) 20 8047 5502
(London) David
Daley
+44 (0) 20 8047 5502
(London) Catherine
Hartley
+44 (0) 20 8047 5502
(London) Sarah
Spencer
+44 (0) 20 8047 5502
(London)
US Media enquiries: Melinda
Stubbee
+1 919 483
2510
(North Carolina) Bernadette
King
+1 215 778
3027
(Philadelphia) Anna
Padula
+1 215 751
4271
(Philadelphia) Karen
Collins
+1 919 483
2527
(North Carolina) Stephen
Rea
+1 215 751
4394
(Philadelphia)
Analyst/Investor enquiries: Ziba
Shamsi
+44 (0) 20 8047 5543
(London) Kirsty Collins (SRI & CG) +44 (0) 20
8047 5534 (London) Tom
Curry
+ 1 215 751
5419
(Philadelphia) Gary
Davies +44
(0) 20 8047 5503 (London)
James
Dodwell
+44 (0) 20 8047 2406
(London) Jeff
McLaughlin
+1 215 751
7002
(Philadelphia) Lucy
Singah
+44 (0) 20 8047 2248
(London)
Genmab enquiries
: Rachel Curtis Gravesen T: +45 33 44 77 20
M: +45 25 12 62 60 E: r.gravesen@genmab.com
Cautionary statement regarding forward-looking
statements GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for
2013. Registered in England & Wales: No.
3888792 Registered Office:
980 Great West Road Brentford, Middlesex TW8 9GS Forward
Looking Statement for Genmab 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(r); the Y-shaped Genmab logo(r);
Genmab in combination with the Y-shaped Genmab logo(tm); the
DuoBody logo(tm); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r);
DuoBody(r); HexaBody(tm) and UniBody(r). 1 Wadhwa P, Morrison
VA. Infectious complications of chronic lymphocytic leukemia.
Seminars in Oncology. 2006;33:240-249.
http://www.cllsupport.org.uk/infections.pdf. Accessed February 12,
2014. 2 Leukemia & Lymphoma Society. Chronic Lymphocytic
Leukemia.
http://www.lls.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/.
Accessed January 3, 2014. 3 American Cancer Society. What are
the key statistics for chronic lymphocytic leukemia?
http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-key-statistics.
Accessed January 3, 2014. 4 Leukemia & Lymphoma Society.
The CLL Guide.
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/leukemia/pdf/cllguide.pdf.
Accessed January 3, 2014. 5 Eichhorst B, Hallek M, Dreyling
M. Chronic lymphocytic leukemia: ESMO clinical recommendations for
diagnosis, treatment and follow-up. Ann Oncol. 2011;22 Suppl 2,
50-54.
http://annonc.oxfordjournals.org/content/22/suppl_6/vi50.full.
Accessed January 3, 2014. 6 Shanafelt, TD, et al. Quality of
life in chronic lymphocytic leukemia: an international survey of
1482 patients. British Journal of Hematology. 2007;139,
255-264.
Company Announcement no. 38 CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark
Genmab A S (PK) (USOTC:GNMSF)
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