Kyowa Kirin Presents Data at EORTC-Cutaneous Lymphoma Task Force Meeting Showing Significantly Improved Quality of Life for Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS) on Mogamulizum

Tokyo (ots/PRNewswire) -

First oral presentation of Quality of Life data from the phase
III trial (MAVORIC), the largest randomised trial in MF and SS -
the two most common types of Cutaneous T Cell Lymphoma[1]

Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces that Quality
of Life (QoL) data from the pivotal MAVORIC trial will be the subject
of an oral presentation,[2] at the European Organization for Research
and Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force (CLTF)
meeting, September 27-29, St. Gallen, Switzerland. A case report of a
long-term responder in the MAVORIC[3] trial will also be reported as
a poster.[4]

Presentation titles at the 2018 EORTC CLTF Mtg:

- Quality of Life in Cutaneous T Cell Lymphoma Patients Treated with
the Anti-CCR4 Monoclonal Antibody Mogamulizumab Versus Vorinostat:
Results from MAVORIC
[Abstract 105; Fri 28th Sept, 11am-12.30pm]
- Long-term complete remission induced by mogamulizumab in a severe
Sezary patient, together with five different possible autoimmune
manifestations [Abstract
#059; Case study poster (external)]

QoL was a secondary end-point of the phase 3 MAVORIC
(mogamulizumab versus vorinostat in previously treated cutaneous
T-cell lymphoma) trial and significant improvements were seen with
mogamulizumab versus vorinostat as early as cycle three and continued
throughout. Using QoL measurements including Skindex-29, Functional
Assessment of Cancer Therapy-General (FACT-G) and EuroQol-5D-3L
(EQ-5D-3L), clinically meaningful improvements in patient-reported
skin-related symptoms and preservation of physical well-being were
observed. >= 61% of mogamulizumab patients reported
clinically-meaningful improvements in skin-related symptoms from
Cycles 3 through to 11 and significantly more vorinostat patients
reported clinically-meaningful declines in physical well-being in
Cycles 1 through to 11. There was also delay in patient reported
deterioration in the Skindex-29 Summary and Emotions subscores in
patients given mogamulizumab.

Dr Pierluigi Porcu, Sidney Kimmel Cancer Center at Jefferson
Health, Thomas Jefferson University, USA elaborates further on the
data: "Cutaneous T cell lymphomas are highly visible cancers, that
can significantly impact patients' QoL. The effects of the disease
can be extremely debilitating, which in turn can affect the patient
both mentally and emotionally. We are extremely excited about these
findings as it demonstrates the potential benefits of mogamulizumab
beyond efficacy and, in particular, for outcomes that are especially
important to people affected by CTCL. It is reassuring to see quick
improvements and benefits across Symptom, Emotional, and Functional
domains. Importantly, patients with the highest symptom burden and
functional impairment derived the most QoL benefit from
mogamulizumab."

Mogamulizumab met its primary endpoint in the MAVORIC trial, which
is the first pivotal trial in CTCL to use progression-free survival
(PFS) as a primary endpoint. The results demonstrated a significant
improvement in PFS and overall response rate (ORR) for mogamulizumab
compared to vorinostat in patients with previously treated MF and
SS.[3] Results of the study were published in Lancet Oncology in
August 2018.

On Friday 21st September 2018, the Committee for Medicinal
Products for Human Use (CHMP), the European Medicines Agency's (EMA)
scientific committee, adopted a Positive Opinion recommending
approval of the marketing authorisation of mogamulizumab for the
treatment of adult patients with MF or SS who have received at least
one prior systemic therapy.

KKI Chief Executive, Tom Stratford, said "There has been limited
innovation in the last fifteen years for patients with MF and SS and
quality of life is a big factor in these diseases. The Kyowa Hakko
Kirin Group companies strive to contribute to the health and
wellbeing of people around the world through advances in life
sciences and technologies and mogamulizumab addresses a universal
unmet need in this patient population. The recent positive CHMP
opinion brings us one step closer to bringing this much needed
treatment to patients with MF and SS."

If mogamulizumab is approved, Kyowa Kirin International PLC, a
Kyowa Hakko Kirin Group company, will be responsible for
commercialising mogamulizumab in Europe.

About Mogamulizumab

Mogamulizumab is a humanised monoclonal antibody (mAb) directed
against CC chemokine receptor 4 (CCR4), which is frequently expressed
on leukemic cells of certain haematologic malignancies including CTCL
(cutaneous T-cell lymphoma). Mogamulizumab was produced using Kyowa
Hakko Kirin's proprietary POTELLIGENT® platform, which is associated
with enhanced antibody-dependent cellular cytotoxicity (ADCC).

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

MF and SS are the two most common subtypes of CTCL[1], a rare type
of non-Hodgkin's lymphoma, which is characterised by localisation of
malignant T lymphocytes to the skin, and depending on the stage, the
disease may involve skin, blood, lymph nodes, and viscera.

About MAVORIC

MAVORIC is a Phase 3 open-label, multi-center, randomised study of
mogamulizumab versus vorinostat in patients with MF and SS who have
failed at least one prior systemic treatment. The study was conducted
in the U.S., Europe, Japan and Australia, and randomized 372 patients
to receive either mogamulizumab or vorinostat.

Additional Data from Analyses

Mogamulizumab resulted in symptomatic and functional improvement
with differences in Skindex-29 Symptoms (Cycle 3 (C3), C5, and C7;
p<0.05) and Functional (C3 and C5; p<0.05) scales.

The proportion of patients who improved by at least the meaningful
change threshold (MCT) from baseline was significantly greater for
mogamulizumab vs vorinostat on Skindex-29 Symptoms at C3 (61.1% vs
45.3%), C5 (64.5% vs 42.4%), C7 (67.1% vs 47.5%), and C11 (84.1% vs
50.0%) and Skindex-29 Functioning domain at C5 (54.3% vs 28.8%).
Significant difference in the FACT-G Physical Well-Being scale (C1,
C3, and C5; p<0.05) were observed in favour of mogamulizumab and a
greater proportion of patients declined by at least the MCT in favour
of mogamulizumab vs vorinostat at C1 (19.3% vs 34.7%), C3 (17.4% vs
42.9%), C5 (13.1% vs 43.3%), and C7 (15.9% vs 37.5%). The median time
to worsening of symptoms on Skindex-29 was 27.4 m for mogamulizumab
vs 6.6 m for vorinostat.

Mogamulizumab Regulatory Status

The Positive Opinion from the Committee for Medicinal Products for
Human Use (CHMP), the European Medicines Agency's (EMA) scientific
committee, recommending approval of the marketing authorisation of
mogamulizumab for the treatment of adult patients with MF or SS who
have received at least one prior systemic therapy has been referred
to the European Commission (EC), which is expected to render its
final decision by the end of 2018. The EC typically adheres to the
recommendation of the CHMP but is not obligated to do so.

On the 8th August 2018, the U.S. Food and Drug Administration
(FDA) granted approval for mogamulizumab for the treatment of adult
patients with relapsed or refractory MF or SS after at least one
prior systemic therapy. Mogamulizumab was granted Priority Review and
Breakthrough Therapy Designation by the FDA in late 2017.

In Japan, mogamulizumab has received approval for: relapsed or
refractory CCR4-positive ATL in March 2012; relapsed or refractory
CCR4-positive PTCL and relapsed or refractory CCR4-positive CTCL in
March 2014; chemotherapy-native CCR4-positive ATL in December 2014;
and, relapsed or refractory CTCL (CCR4-positive removed) in August
2018.

About Kyowa Kirin

Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences
company, with special strengths in biotechnologies. In the core
therapeutic areas of oncology, nephrology and immunology/allergy,
Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on
antibody technologies, to continually discover innovative new drugs
and to develop and market those drugs world-wide. In this way, the
company is working to realise its vision of becoming a Japan-based
global specialty pharmaceutical company that contributes to the
health and wellbeing of people around the world.

Kyowa Kirin International PLC is a wholly owned subsidiary of
Kyowa Hakko Kirin and is a rapidly growing specialty pharmaceutical
company engaged in the development and commercialisation of
prescription medicines for the treatment of unmet therapeutic needs
in Europe and the United States. Kyowa Kirin International is
headquartered in Scotland.

You can learn more about the business at:
http://www.kyowa-kirin.com

1. Leukemia & Lymphoma Society. Cutaneous T-Cell Lymphoma Facts. h
ttp://www.lls.org/sites/default/files/file_assets/FS5_Cutaneous%20T-C
ell%20Lymphoma_2014_Final.pdf . Accessed May 2, 2018

2. Pierluigi Porcu et al. Quality of Life in Cutaneous T Cell
Lymphoma Subjects Treated with the Anti-CCR4 Monoclonal Antibody
Mogamulizumab Versus Vorinostat: Results from MAVORIC. Data presented
at ASCO and EHA, and oral presentation at EORTC, 2018

3. Youn H Kim et al. Mogamulizumab versus vorinostat in previously
treated cutaneous T-cell lymphoma (MAVORIC): an international,
open-label, randomised, controlled phase 3 trial. Lancet Oncology
2018. Sep;19(9):1192-1204

4. Long-term complete remission induced by mogamulizumab in a
severe Sezary patient, together with five different possible
autoimmune manifestations [Abstract #059; Case study poster
(external)]

ots Originaltext: Kyowa Kirin International PLC
Im Internet recherchierbar: http://www.presseportal.de

Contact:
media@kyowa-kirin.co.jp
Debbie Johnston
Spreng Thomson Ltd. (For Kyowa Kirin International PLC)
+44(0)141-548-5191
Mobile: +44(0)532-183811
Email: debbie@sprengthomson.com
Yvette Venable
Kyowa Kirin International PLC
+44-7388-222-769
Email: Yvette.Venable@kyowakirin.com

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