Onco Actu du 5 décembre 2016

	2.10 Etiologie - Alcool
Melanoma and Alcohol: Another Explanation [ACS] 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.
	5.12 Immunothérapies
Immune System, Unleashed by Cancer Therapies, Can Attack Organs [NY Times] “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.
	5.12.2 Immunothérapies - CAR-T
The Xconomy Immuno-Oncology Resource: A Mid-ASH T Cell Update [Xconomy] 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.
Patient Deaths, Safety Concerns Cause Juno's CAR-T Pipeline to Skid Out [The Street] Juno now finds itself one year, if not two years or more, behind rivals Novartis and Kite.
Kite adds promising leukemia responses in small CAR-T studies, then fires the starting gun on its rolling submission [EndPoints] “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.”
Kite Pharma Initiates Rolling Submission of U.S. Biologics License Application (BLA) for KTE-C19, its Investigational anti-CD19 CAR-T Therapy, for the Treatment of Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL) [Business Wire] Kite also announced that the United States Adopted Name, or USAN, for KTE-C19 will be axicabtagene ciloleucel.
	5.12.3 Immunothérapies-combinaisons
Encouraging Survival Observed With Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Longer Follow-up in First-line Advanced Non-small Cell Lung Cancer, in Updated Phase 1b CheckMate -012 Study [BMS] In the pooled combination cohorts, median progression-free survival in patients with PD-L1 expression ≥1% was 12.7 months.
	5.2 Pharma
Boehringer axes small-molecule discovery ops as R&D focus shifts to immuno-oncology [FierceBiotech] 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.
	5.4 Traitements - Economie
James Raftery: Changes to how NICE appraises drugs and other health technologies [BMJ] 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.
	5.8 ASH
As the world’s top blood experts gather, 5 key questions to watch 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.
	5.8.1 ASH - Communiqués
IMBRUVICA® (ibrutinib) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma 5-Year Analysis and Long-Term RESONATE-2 Follow-up Data at ASH 2016 Show Lasting Efficacy [AbbVie] Nearly nine out of 10 patients (89%) with CLL/SLL achieve complete or partial response at five-year analysis.
Takeda and Seattle Genetics Report Positive Phase 3 ALCANZA Clinical Trial Data of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma [Takeda] 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.
Favorable Response Rates Suggest Promise of Ibrutinib (IMBRUVICA®) Combination Therapy in Two Common Types of Non-Hodgkin's Lymphoma [AbbVie] New data available for ibrutinib in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and in first-line follicular lymphoma (FL).
Roche’s Gazyva/Gazyvaro Helped People With Previously Untreated Follicular Lymphoma Live Significantly Longer Without Their Disease Worsening Compared to MabThera/Rituxan [Roche] 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.
Studies Advance a More Personalized Approach to Treatment [ASH] 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 .
Bioengineering Innovations Show Promise for Improving Treatments and Drug Delivery [ASH] New methods could significantly advance therapy for trauma, hemophilia, and cancer.
	5.8.3 ASH - Divers
When yesterday’s cancer “discovery” is reversed by today’s better evidence — a cautionary tale for PR professionals and journalists [HealthNewsReview] 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.
	5.8.4 ASH - CAR T
Juno Therapeutics Announces Complete Response and Corresponding Early Survival Data for JCAR014 in Patients with Ibrutinib-Refractory CLL [Juno] Study data support the development of JCAR017 in CLL.
Rivals Kite and Novartis post new CAR-T data as both plot FDA approval [FierceBiotech] 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.
CD19-targeting CAR T-cell immunotherapy yields high responses in treatment-resistant CLL [Fred Hutch] 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.
Kite Pharma Reports 82 Percent of Patients Achieved Complete Remission in Preliminary Analysis from Phase 1 ZUMA-3 and ZUMA-4 Trials of KTE-C19 in Adult and Pediatric Patients with High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia [Kite] 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.
Novartis presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL [Novartis] 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.
In wake of a CAR-T restructuring, Novartis says it’s ready to hunt a pioneering OK for lead program [EndPoints] 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.
Lethally severe neurotoxicity continues to haunt Juno’s CAR-T pipeline [EndPoints] 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.
Novartis says 82 percent of leukemia patients in remission after CAR-T [Reuters] 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.
New data on risk vs benefit for potent CAR-T cancer drugs [Reuters] 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.
	5.8.6 ASH - Leucémies
#ASH16: Pfizer offers a thumbs-up on OS data from PhII blood cancer study of glasdegib [EndPoints] The median OS for the combo drug arm was 8.8 months compared to only 4.9 months for LDAC as a monotherapy.
	6.10.1 Politiques (USA)
Statement from the American Association for Cancer Research on the House Passage of the 21st Century Cures Act [AACR] 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.
	6.4 Médico-éco
Medicare recipients with cancer face financial distress [Reuters] 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.
	6.6 Publications
It’s time to overhaul the secretive peer review process [STAT] 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.