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GUSTAVE ROUSSY AT THE ASCO
PRESS RELEASE
29
TH
MAY
02
ND
JUNE
2015
PAEDIATRIC
CANCERS
www.gustaveroussy.fr/asco2015
Press release
Gustave Roussy at the 51th Congress of the American Society of Clinical Oncology
PAEDIATRIC CANCERS
TARGETED THERAPIES
EVALUATED IN PHASE I:
PROMISING RESULTS
Dr Birgit Geoerger of the Gustave Roussy Department of
Childhood and Adolescent Oncology (Villejuif) delivered
two oral communications in the session devoted to
paediatric oncology on the 30th May at the 51st ASCO
Conference. Both communications reported beneficial
effects of targeted therapy in phase I paediatric clinical
trials. These agents had already been shown to be useful
in adults with different conditions. The first trial assessed
dabrafenib, a tyrosine kinase inhibitor, in children with
various solid tumours expressing the BRAF V600E
mutation. Notably, this targeted therapy was found to be
effective in high grade glioma. This is a world first.
The second study demonstrated the efficacy of ceritinib,
an inhibitor of the ALK pathway, in children with a variety
of tumour types, all displaying damage to the ALK gene.
Both trials show that it is important to adjust an
anti-cancer treatment to the abnormal molecular
characteristics of the patient’s tumour, illustrating the
principle of “precision medicine”, a project launched in
paediatrics at Gustave Roussy in 2012.
III PROMISING PHASE I
RESULTS FOR DABRAFENIB
IN CHILDREN
Dabrafenib is an agent which up
till now has been used in adults
with non-resectable or metastatic
melanoma bearing the BRAF
V600E mutation.
This phase I clinical trial was
designed to determine the dose to
recommend for children with solid
tumours, which are refractory to
treatment or in relapse (low and
high grade glioma, Langerhans
cell histiocytosis and other solid
tumours), and which have the
same mutation.
27 patients with a median age of
9 years participated in this study.
Dabrafenib was taken twice daily.
The drug was well tolerated with
an acceptable level of toxicity. The
ASCO
2015
Flash and find
#10005
1. Phase I study of ceritinib in
pediatric patients (Pts) with
malignancies harboring a genetic
alteration in ALK (ALK+): Safety,
pharmacokinetic (PK), and efficacy
results
Birgit Geoerger, Johannes Schulte,
Christian M. Zwaan, Michela
Casanova, Matthias Fischer, Lucas
Moreno, Toby Trahair, Irene Jimenez,
Hyoung Jin Kang, Alberto S. Pappo,
Eric Schafer, Brian D. Weiss, Mary
Ellen Healy, Ke Li, Tiffany Lin, Anthony
Boral, Andrew DJ Pearson
recommended dose in patients
aged less than 12 years was 4.5 mg/
kg/day and for those aged 12 years
and over it was 5.25 mg/kg/day.
A high proportion of the group
responded to treatment with a
reduction in size of the tumour on
imaging. This applied to various
types of cancer. 21 children are
still taking the medication. In the
8 patients with high grade glioma,
there were 3 complete responses
and 2 durable partial ones (63%
objective response). Both patients
with Langerhans cell histiocytosis
had a complete response.
These results demonstrate that
this treatment should be instituted
once a diagnosis of malignant
glioma with a BRAF V600 mutation
has been made.
III EFFICACY OF CERITINIB
IN PHASE I
Ceritinib has been shown to be
effective in adults with non-small
cell lung cancer expressing
abnormalities of the ALK gene.
All the children recruited
for this phase I international
paediatric clinical trial had
the same gene affected. The
principal conditions seen were
anaplastic large cell lymphoma,
myofibroblastic tumours,
inflammatory myofibroblastic
tumours, rhabdomyosarcoma and
neuroblastoma.
The median age of the 22
participating patients was 10
years. They came from 22 centres
in 10 countries. They received
doses of ceritinib ranging from
300 to 560 mg/m2/day and the
drug was administered in the
fasting state. The study has
been proceeding for 18 months.
It is still ongoing and the dose
that should be administered
with food is being assessed.
The side effect profile is similar
to that observed for this agent
in the adult. The main adverse
effects are gastrointestinal. The
recommended dose in the fasting
state is 510 mg/m2/day.
Ceritinib has been shown to
be very effective in children
with anaplastic large cell
lymphoma and in inflammatory
myofibroblastic tumours, both
conditions being associated with
the presence of a fusion protein
which activates ALK.
ASCO
2015
Flash and find
#10004
2. Phase 1 study of dabrafenib
in pediatric patients (pts) with
relapsed or refractory BRAF V600E
high- and low-grade gliomas (HGG,
LGG), Langerhans cell histiocytosis
(LCH), and other solid tumors (OST).
Paediatrics at Gustave Roussy
In 1950 Gustave Roussy established the
first Paediatric Oncology Department
in France. It has developed innovative
treatments which have become standard
therapy throughout the world. It has
engaged in research to reduce the
unwanted consequences of treatment
and conducted early trials of new
drugs. It argued for a law to oblige the
pharmaceutical industry to provide drugs
which are effective in adults in forms
suitable for children.
Dr Dominique Valteau-Couanet is Head
of the Department of Childhood and
Adolescent Oncology, which specialises
in the diagnosis of solid tumours and
lymphomas. Since 2012 the department
has been responsible for an innovative
project in which former patients, now
adults and cured of their childhood cancer,
are followed in the long term.
Each year Gustave Roussy sees more than
410 new patients aged less than 18 years
with a diagnosis of cancer. The medical
team consists of 16 doctors and 80 other
care staff (nurses, psychologists, nursing
assistants, etc.)
Mark W. Kieran, Darren R Hargrave,
Kenneth J. Cohen, Isabelle Aerts,
Ira J. Dunkel, Trent Ryan Hummel,
Irene Jimenez, Andrew DJ Pearson,
Christine A. Pratilas, James Whitlock,
Eric Bouffet, Wei-Ping Violet Shen,
Alberto Broniscer, Anne-Isabelle
Bertozzi, Joan L Sandberg, Allison
M. Florance, Benjamin B. Suttle, Pat
Haney, Mark W. Russo, Birgit Geoerger
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
christine.lascombe@gustaveroussy.fr
MEDIAL :
Claire Parisel
01 53 83 81 52
claireparisel@medial-rp.com
www.gustaveroussy.fr
www.gustaveroussy.fr/asco2015
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