ONCOLOGY
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Pioneers in solid tumours:
A spotlight on Janssen Oncology
Dr Joaquín Casariego discusses Janssen’s solid tumour portfolio and pipeline,
highlighting their commitment to improving outcomes in the solid tumour space
Joaquín Casariego
MD EMBA
Janssen Therapeutic Area
Lead Oncology, Europe,
Middle East & Africa
Cancer doesn’t
have a
‘one-size fits all’
approach,
and neither
should we
Having worked in the pharmaceutical industry for
over 20 years, I joined Janssen in 2016 as EMEA
Medical Director Oncology and began my current
role as EMEA Therapeutic Area Lead Oncology in
2019.
At Janssen we have been active in oncology for
over 30 years, significantly contributing to
improved patient outcomes in the solid tumour
space. Our driving passion is to bring innovative
medicines to patients at the earliest stages of their
disease where there is maximum potential for cure
and, when not possible, have the highest impact
on patient outcomes.
Within the last seven years, we have recognised
numerous milestones across our solid tumour
portfolio in Europe – from launching two
treatments in prostate cancer, abiraterone acetate
(Zytiga ® ) 1 and apalutamide (Erleada ® ), 2 to seeing
abiraterone acetate included in the World Health
Organization (WHO) Essential Medicines List for
the treatment of metastatic castration-resistant
prostate cancer (mCRPC). 3
In addition to our approved products in prostate
cancer, we have a strong late-stage pipeline in solid
tumours. Our focus is on discovering best-in-class,
innovative medicines for cancers where patient
and their families’ needs are greatest. We do this
by pursuing the cancer types and sub-types that we
know best, and where we can achieve the highest
impact – both in transforming patients’ lives today
and in moving closer to a cure tomorrow.
This is demonstrated by the ongoing Phase II
GALAHAD study, exploring niraparib, an orally-
administered poly-ADP-ribose-polymerase (PARP)
inhibitor for third-line treatment of adult men
with mCRPC with bi-allelic DNA-repair defects
(DRD). 7 There is currently a high unmet need in
this particular patient group and we were
delighted to share positive preliminary results
from the GALAHAD study earlier this year. 7 In
addition, the Phase III MAGNITUDE trial is
exploring the efficacy and safety of the novel
combination of niraparib plus abiraterone acetate
as first line treatment of mCRPC patients with and
without DRD. 10
In recent years, drug development in early
disease stages of cancer has been limited by a lack
of clinically relevant endpoints. As our research
explores earlier stages there is a greater need to
find endpoints to replace long term endpoints such
as overall survival. To address this, Janssen created
a pioneering development strategy to address how
our medicines are evaluated and approved.
6
HHE 2019 | hospitalhealthcare.com
Timeline of European milestones
in solid tumours
• September 2011 European Commission (EC)
approval of abiraterone acetate for mCRPC 4
• November 2017 EC extends licence for
abiraterone acetate for high-risk mHSPC 5
• January 2019 EC approval of apalutamide for
high-risk non-metastatic castration-resistant
prostate cancer 6
• February 2019 Preliminary results of Phase II
GALAHAD study announced 7
• May 2019 First presentation of TITAN data at
ASCO annual meeting 8
• June 2019 Submission to EMA for a Type II
variation to the apalutamide label based on TITAN
data in mHSPC 9
• July 2019 Inclusion of abiraterone acetate into
the WHO Essential Medicines list 3
Janssen’s use of novel primary
endpoints in solid tumours
• Metastasis-free survival (MFS): SPARTAN study, 12
ATLAS, 13 PROTEUS 14
• Pathologic complete response (pCR): PROTEUS
study 14
Although overall survival is still considered the
gold standard of interventions in trials, together
with clinical experts in the field, we are developing
clinical trial programmes that maximise the
impact of novel surrogate and intermediate
endpoints with a view to redefine patient
outcomes at all disease stages. 11
Our use of novel efficacy endpoints has
supported several submissions to regulatory bodies
including the submission and approval of
apalutamide for patients with high-risk non-
mCRPC (nmCRPC). 1 This approval was based on the
Phase III SPARTAN study, which showed
statistically significant improvement versus
placebo for the primary endpoint of metastasis-
free survival. 12
Not only is it important to develop innovative
medicines for the treatment of cancer, but it is
vital that patients have the opportunity to get the