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2.10 Etiologie - Alcool
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While
the investigators of this study did attempt to control for difference
in sun exposure, another factor, the use of tanning beds which emit UV
radiation and are a known cause of melanoma, may be the culprit.
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5.12 Immunothérapies
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“We
are playing with fire,” said Dr. John Timmerman, an oncologist and
immunotherapy researcher at the University of California, Los Angeles,
who recently lost a patient to side effects.
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5.12.2 Immunothérapies - CAR-T
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The
resource is a top-line look at how people have fared with the growing
array of products, most of them still experimental, which have attracted
so much attention but come with caveats as well.
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Juno now finds itself one year, if not two years or more, behind rivals Novartis and Kite.
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“In
the Phase I portion of these studies, we only enrolled patients with
high disease burden to rigorously evaluate safety and efficacy of
KTE-C19,” said Kite R&D director David Chang. “We look forward to
initiating the Phase II portions of these studies in 2017.”
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Kite also announced that the United States Adopted Name, or USAN, for KTE-C19 will be axicabtagene ciloleucel.
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5.12.3 Immunothérapies-combinaisons
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In the pooled combination cohorts, median progression-free survival in patients with PD-L1 expression ≥1% was 12.7 months.
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5.2 Pharma
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There
is some movement in the other direction jobs-wise, however, as the
company says it intends to set up a new immuno-oncology research unit at
the Ridgefield site next year. Once up and running that should provide
35 new positions, according to Boehringer spokesperson Erin Crew.
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5.4 Traitements - Economie
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The
recent proposals by NICE and NHS England to change arrangements for
evaluating and funding drugs and other health technologies not only tidy
up the processes, but introduce some important new elements.
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5.8 ASH
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As
we hurtle toward the era of cell therapies, such as CAR-T, one key
question is how to scale up such highly personalized treatments — and
how to do it in a cost effective way.
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5.8.1 ASH - Communiqués
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Nearly nine out of 10 patients (89%) with CLL/SLL achieve complete or partial response at five-year analysis.
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Trial
achieved highly statistically significant improvements in rate of
objective response lasting at least four months, median progression-free
survival and overall response rate, and decrease in symptom burden in
ADCETRIS arm; Safety profile associated with ADCETRIS was generally
consistent with the existing prescribing information.
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New
data available for ibrutinib in relapsed/refractory diffuse large
B-cell lymphoma (DLBCL) and in first-line follicular lymphoma (FL).
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First
Phase III study to show superior progression-free survival compared to
MabThera/Rituxan-based standard of care treatment for most common
slow-growing form of non-Hodgkin lymphoma.
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A
point-of-care blood test, new findings on management of leukemia, and
insights on intravenous lines for children offer tools to support
patient-centered care .
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New methods could significantly advance therapy for trauma, hemophilia, and cancer.
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5.8.3 ASH - Divers
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Thompson
contacted me again yesterday to point out that a much larger follow-up
study had just been presented at the American Society of Hematology
meeting. He said that these new results — from 96 patients, as opposed
to the previous study’s 3 — suggest that there is no role for lysolipids
in most cases of myeloma.
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5.8.4 ASH - CAR T
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Study data support the development of JCAR017 in CLL.
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Juno
now seems to be out of the running after a string of deaths from
several studies this year severely hampered its prospects of getting a
new CAR-T to market any time soon, with big questions over the very
future of the biotech itself.
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In
a small, early phase trial, a high percentage of patients who had
exhausted most traditional treatments for chronic lymphocytic leukemia
saw their tumors shrink or even disappear after an infusion of a highly
targeted, experimental CAR T-cell immunotherapy developed at Seattle’s
Fred Hutchinson Cancer Research Center.
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Five
of 13 (38 percent) patients had ≥ grade 3 cytokine release syndrome
(CRS) and five of 13 (38 percent) had ≥ grade 3 neurological events. One
patient in ZUMA-3 died from KTE-C19 related CRS and one patient in
ZUMA-4 died from a disseminated fungal infection unrelated to KTE-C19.
No cerebral edema has been observed.
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Novartis
pivotal data from ELIANA is supported by CTL019 US multicenter trial
(ENSIGN) as well as earlier single site trial in r/r pediatric and young
adult patients with B-cell ALL.
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Novartis
managed to stun practically everyone in the field when it abruptly
disbanded its cell and gene therapy unit three months ago, laying off
120 and integrating another 280 back into its regular R&D ranks as
CAR-T chief Usman ‘Oz’ Azam hit the exit.
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The
biotech was forced to concede Saturday that investigators had tracked 6
cases of severe, grade 3-5 neurotoxicity out of 24 patients in a
separate JCAR014 trial for chronic lymphocytic leukemia.
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Interim
results from the multi-center trial for 50 patients with acute
lymphoblastic leukemia whose cancer returned or did not respond to other
treatment, showed that 41 were disease-free three months after
treatment with the drug, called CTL019.
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Early
excitement over the drugs has propelled investor interest in biotech
Kite Pharma Inc, whose shares have tripled since a 2014 initial public
offering, as well as rival Juno Therapeutics Inc, whose therapy JCAR015
has generated concerns after five leukemia patients died due to severe
brain swelling. Juno shares now trade about 14 percent below their IPO
price.
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5.8.6 ASH - Leucémies
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The median OS for the combo drug arm was 8.8 months compared to only 4.9 months for LDAC as a monotherapy.
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6.10.1 Politiques (USA)
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House
passage of this legislation is only the first step forward. We urge the
Senate to also pass the bill. It is also vitally important that the
National Institutes of Health (NIH) receive robust, sustained, and
predictable funding increases through the regular appropriations
process.
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6.4 Médico-éco
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On
average, for example, patients with Medicaid paid $2,116, those insured
by the Veterans Health Administration paid $2,367, those with
employer-sponsored insurance paid $5,492, those with Medigap policies
paid $5,670, those insured by a Medicare HMO paid $5,976, and those with
traditional Medicare and no supplemental insurance paid $8,115.
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6.6 Publications
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Reading
a paper in “final form” without access to the back-and-forth of reviews
and editorial commentary deprives readers of key insights into how the
research was conducted.
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