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GUSTAVE ROUSSY AT THE ASCO
PRESS RELEASE
29
TH
MAY
02
ND
JUNE
2015
EARLY
CLINICAL TRIALS
www.gustaveroussy.fr/asco2015
Press release
Gustave Roussy at the 51th Congress of the American Society of Clinical Oncology
EARLY CLINICAL TRIALS
FIRST EVALUATIONS OF THE
THERAPIES OF THE FUTURE
Early trials at Gustave Roussy are led by the Drug
Development Department (DITEP), which is directed
by Professor Jean-Charles Soria. Four of the DITEP
doctors presented promising results on Saturday, 30th
May and Monday, 1st June.
Dr Andrea Varga showed that an immunological
therapeutic agent shown to be effective in melanoma
produced good results in patients with advanced
ovarian cancer which had not responded to more
than one drug. Dr Eric Angevin assessed a new
immunological agent (anti-CD26) for the first time in
man. Dr Antoine Hollebecque studied a combination of
two known anti-cancer agents analysing their activity in
patients with solid tumours where previous medication
had been ineffective. Dr Anas Gazzah reported results
obtained in solid tumours using a different combination
of two targeted drugs.
III NEW HOPE FOR
IMMUNOTHERAPY THERAPY
IN OVARIAN CANCER
Pembrolizumab is a highlyselective monoclonal antibody
which relieves inhibition of T
lymphocyte anti-cancer activity
by blocking the interaction
between PD-1 and its ligands
(PD-L1, L2). It was recently
evaluated in melanoma where
it has very convincingly been
shown to be superior to another
immunological agent (phase III
study).
The PD-L1 ligand may be overexpressed in ovarian tumours and
this phenomenon may contribute
to their invasiveness.
The KEYNOTE-028 phase Ib
study was delivered as an oral
communication on Monday,
1st June by Dr Andrea Varga, a
doctor in the DITEP team. This
study assessed the efficacy and
safety profile of pembrolizumab
in 26 patients with advanced
ASCO
2015
Flash and find
# 5510
1. Antitumor activity and safety of
pembrolizumab in patients (pts)
with PD-L1 positive advanced
ovarian cancer: Interim results
from a phase Ib study.
Andrea Varga, Sarina Anne Piha-Paul,
Patrick Alexander Ott, Janice M.
Mehnert, Dominique Berton-Rigaud,
Elizabeth A. Johnson, Jonathan D.
Cheng, Sammy Yuan, Eric H. Rubin,
Daniela E. Matei
ovarian cancer, cancer of the
Fallopian tubes or primary
peritoneal cancer. The PD-L1
ligand was over-expressed in
these tumours. The patients
had experienced at least one
therapeutic failure.
Pembrolizumab was
administered at a once-weekly
dose of 10 mg/kg for two years
or until tumour progression was
noted or side effects became
too prominent. The commonest
adverse effects were: fatigue
(42.3%), anaemia (30.8%) and loss
of appetite (30.8%). A reduction
in tumour size was observed in
23% of the patients in whom the
previous chemotherapeutic load
had been substantial (failure
of 2 to 4 lines of treatment). At
present 6 patients remain on
pembrolizumab in the context of
this trial.
III FIRST STUDY IN MAN OF
A NEW ANTIBODY DIRECTED
AGAINST CD26
CD26 is a biomarker which is
strongly expressed on the cell
surface of certain cancers such
as mesothelioma. It is also
involved in immune regulation.
YS110 is a new antibody directed
against CD26 and its potential
has been demonstrated in
pre-clinical studies. Dr Eric
Angevin led a study to evaluate
its effects in man for the first
time. This involved 34 patients
with solid tumours expressing
CD26, principally advanced
mesothelioma, so as to
determine a recommended dose
and to assess its safety profile.
YS110 was administered at a
dose ranging from 0.1 to 6 mg/
kg without reaching dose-limiting
toxicity.
The adverse effects seen were:
asthenia (33.3%), hypersensitivity
(30%), shivering (13.3%), pyrexia
(13.3%), nausea (13.3%), vomiting
(10%) and headache (10%). These
were not dose-dependent. The
initial results, presented on
Saturday, May 30th, showed that
disease was stabilised in 13 of
the patients treated (of the 25
whose results could be assessed)
and that YS110 appears to be well
tolerated.
III EVALUATION OF THE
SYNERGISTIC EFFECT OF
TWO KNOWN THERAPEUTIC
AGENTS
Temsirolimus is a selective
inhibitor of the mTOR protein,
which is currently used to treat
renal carcinoma and mantlecell lymphoma. Cetuximab is a
monoclonal anti-EGFR antibody
and is used in metastatic
colorectal cancer and in locally
advanced squamous cell
carcinoma of the head and neck.
Their synergistic effects had
been evaluated in pre-clinical
studies. In a Gustave Roussysponsored phase I study, Dr
Antoine Hollebecque examined
the activity and safety of a
combination of these two drugs
in 39 patients with a variety
of solid tumours, who had
already received more than one
treatment.
The objectives were to ascertain
the recommended dose, to
study the pharmacokinetics
and to examine the safety
profile of the drug combination.
The recommended dose
was fixed at 250 mg/m2/
week for cetuximab and 25
mg/week for temsirolimus.
The results presented on
30th May demonstrate that
this combination has a
role, particularly in those
patients who have molecular
ASCO
2015
Flash and find
#2519
2. First-in-human phase I
administration of YS110,
a monoclonal antibody
directed against the CD26
immunostimulatory molecule in
advanced cancer patients.
Eric Angevin, Nicolas Isambert,
Veronique N. Trillet-Lenoir, Benoit You,
Jérôme Alexandre, Gerard Zalcman,
Philippe Viehl, Françoise Farace,
Fanny Valleix, Thomas Podoll, Yu
Kuramochi, Itaru Miyashita, Osamu
Hosono, Nam H. Dang, Kei Ohnuma,
Taketo Yamada, Yutaro Kaneko, Chikao
Morimoto
Flash and find
#2599
3. Phase I study of temsirolimus
in combination with cetuximab
in patients with advanced solid
tumors.
Antoine Hollebecque, Rastislav
Bahleda, Jean Christophe Thery,
Laura Faivre, Marie-Cécile Le Deley,
Angelo Paci, Andrea Varga, Anas
Gazzah, Christophe Massard, Vianney
Poinsignon, Katty Malekzadeh, Vincent
Ribrag, ERIC ANGEVIN, Sophie PostelVinay, Carlos Alberto Gomez-Roca,
Myriam Gharib, Fabienne Dufour,
Jean-Charles Soria, Jean-Philippe
Spano
abnormalities affecting the EGFR
and/or the PIK3 pathways. The
safety profile is acceptable.
III COMBINATION OF TWO
TARGETED THERAPEUTIC
AGENTS
In another phase I study,
presented on Saturday, 30th
May, Dr Anas Gazzah reported
efficacy data from a study in
49 patients of the two targeted
drugs, cetuximab and afatinib, in
combination. This combination
was tolerated and the
recommended doses were 40 mg
daily for afatinib and 250 mg/m2
weekly for cetuximab.
Prolonged disease stability was
observed both in cancers of the
upper airways and squamous cell
cancer of lung.
ASCO
2015
A department devoted
to early clinical trials
The Gustave Roussy’s Drug Development
Department (DITEP) is committed to
the conduct of phase I clinical trials. Its
objective is to offer patients access to
novel agents in a situation where previous
therapy has failed, and to streamline the
development of new drugs.
It has been designated an Early Phase
Centre (CLIP) by the National Cancer
Institute. 100 whole-time equivalent
personnel work within the Department.
DITEP’s activities are guided by a
multidisciplinary committee of experts
in medical oncology, radiotherapy,
haematology, imaging, biology and
pathology.
Its director is Professor Jean-Charles
Soria. By virtue of the productive
partnerships created by Gustave Roussy,
DITEP helps a continually increasing
number of patients to gain access to
innovative drugs. Since its establishment
in September 2013, this department
has continued to grow and extend its
work. 22% of its phase I trials involve
immunological targeting, which makes
DITEP the leading European centre for
early exploration of immuno-oncological
agents.
Flash and find
#2536
4. Phase Ib study of afatinib plus
standard-dose cetuximab in
patients (pts) with advanced solid
tumors.
Anas Gazzah, Valentina Boni, JeanCharles Soria, Esther Holgado,
Caroline Even, Mahmoud Ould Kaci,
Serge Nazabadioko, Wenqiong Xue,
Emiliano Calvo
The Gustave-Roussy medical researchers reveal
their research findings in 56 presentations at the
American Society of Clinical Oncology Conference.
The ASCO scientific committee selected 22 oral
communications, 5 of which were to be presented
directly by the Institute, 7 posters for discussion,
5 of which to be presented by Gustave-Roussy, and
25 posters.
At this 51st meeting of the most important world
conference in oncology, Gustave Roussy confirms
its leading position in two therapeutic fields which
are being absorbed into day-to-day management
and are resulting in changes in practice within
the Department of Medical Oncology (DMO):
immunotherapy which is being developed in new
disease areas, and targeted therapies and novel
approaches to tumour resistance to treatment.
This 2015 meeting will also be noteworthy for
the early evaluation through phase I clinical
trials of what will become tomorrow’s therapies,
in particular within DITEP (Drug Development
Department) at Gustave Roussy.
ASCO
MAY 29TH – JUNE 2ND, 2015
51 TH CONGRESS
American Society of Clinical
Oncology (Asco, Chicago, USA,
May 29th – June 2nd 2015).
ABOUT GUSTAVE ROUSSY
About Gustave Roussy
Gustave Roussy is the first
comprehensive cancer centre
in Europe. It is a focus of
comprehensive expertise in the
cancer field, entirely dedicated to
patients. The campus houses 3,000
professional staff engaged in patient
care, research and teaching.
– www.gustaveroussy.fr
PRESS CONTACT
GUSTAVE ROUSSY :
Communication Department
Christine Lascombe
+33 1 42 11 47 05
+33 6 26 36 76 17
[email protected]
MEDIAL :
Claire Parisel
01 53 83 81 52
[email protected]
www.gustaveroussy.fr
www.gustaveroussy.fr/asco2015
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