Onco Actu du 9 décembre 2019

	2.13 ETIOLOGIE - NDMA
EMA update on metformin diabetes medicines [EMA] Patients in the EU should continue taking their metformin medicines as normal. The risk from not having adequate diabetes treatment far outweighs possible effects of the low levels of NDMA seen in tests. Healthcare professionals should remind patients of the importance of keeping their diabetes under control.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Update: Demographic, Product, and Substance-Use Characteristics of Hospitalized Patients in a Nationwide Outbreak of E-cigarette, or Vaping, Product Use–Associated Lung Injuries — United States, December 2019 [CDC] These data further support the association of EVALI with THC-containing products; it is unlikely that one brand is responsible for the outbreak. CDC recommends that persons not use e-cigarette, or vaping, products that contain THC.
	5.10 TRAITEMENTS - ESSAIS
BRAF Inhibitor Shows Promising Results in Pediatric Patients with Low-Grade Glioma [AACR] In this phase I/IIa study, Hargrave and colleagues examined the efficacy of an oral targeted therapy called dabrafenib in patients with pediatric low-grade glioma. Dabrafenib selectively inhibits a mutated form of the BRAF protein that causes cell growth.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Novartis downsizing internal efforts on CAR T in solid tumors [BioCentury] Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use internal talent to solve the problems of first-generation products.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
Watch out, Keytruda. Ferring's bladder cancer gene therapy rival has new data—and they look competitive [Fierce Pharma] Priority reviews in hand, the two companies could be looking at FDA approvals soon. The burning question is, how does FerGene plan to price a gene therapy, which belongs to a class of drug that’s notoriously costly?
Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma [Janssen] Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory multiple myeloma.
	5.12.8 IMMUNOTHÉRAPIES - ECONOMIE
Swiss approve insurance cover for Novartis, Gilead cell therapies [Reuters] “The contract between hospitals and the health insurers will be approved until the end of 2020, granting the affected patients immediate access to these therapies,” the government said after a cabinet meeting.
	5.2.6 PHARMA - BIOTECH
On the heels of a PhIII implosion, cancer biotech Mologen is turned over to the liquidator [EndPoints] Mologen filed for insolvency a few days ago, months after its lead drug — the TLR9 agonist lefitolimod — failed badly in Phase III.
Black Diamond raises another $85M to bring new oncogene approach into clinic [EndPoints] Allosteric therapies are essentially like other oncogenetic therapies, such as kinase drugs, that inhibit a protein fueling cancer. But rather than try to inhibit the protein straight-on, these therapies target cancers that emerge from mutations in networks, or an “ensemble,” of domains that affect each other from a distance.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
FDA Approving Drugs at Breakneck Speed, Raising Alarm [Bloomberg] The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates.
	5.7 SABCS
SABCS to Showcase Advances in Breast Cancer Treatments [Cancer Research Catalyst] Among several eagerly anticipated studies on this year’s program is a phase II trial of the HER2-targeted treatment tucatinib, given in combination with trastuzumab (Herceptin) and capecitabine for patients with metastatic HER2-positive breast cancer.
	5.8.1 ASH - COMMUNIQUÉS
The Leukemia & Lymphoma Society (LLS) and The American Society of Hematology (ASH) Team Up to Connect Blood Cancer Patients to Clinical Trials that Can Lead to New and Better Treatments [ASH] With only approximately five percent of adult cancer patients enrolling in clinical trials, this collaboration aims to bridge this gap and connect more blood cancer patients to appropriate clinical trials.
	5.8.2 ASH - PHARMA
Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer [Pfizer] “Results from these analyses are a welcomed addition to the growing body of data around recurrent VTE in patients with active cancer.”
	5.8.4 ASH - CAR-T
Bristol-Myers Squibb Announces Studies Evaluating liso-cel in Multiple Additional Patient Populations, Site of Care and Disease Areas Presented at American Society of Hematology (ASH) Annual Meeting [BMS] Heavily pre-treated patients with chronic lymphocytic leukemia receiving liso-cel achieved durable complete responses, including undetectable minimal residual disease.
New Approaches Aim to Enhance CAR T-Cell Therapy [ASH] Second-generation products may overcome resistance, reduce toxicity, simplify treatment.
	5.8.5 ASH - MYÉLOME MULTIPLE
Myeloma cell therapies, now in pharma hands, move into spotlight [Biopharma Dive] While Bristol-Myers and Bluebird currently lead, earlier-stage data from Johnson & Johnson suggest that advantage may be rapidly diminishing.
ASH: Gilead Sciences touts 'astounding' Yescarta survival results at 3 years [Fierce Pharma] The data highlight “one of the most important features of the molecule because it consistently delivers that response rate,” he added. “Essentially what it’s saying is, you’ve got an approximately 50% chance of being alive at three years. There really is no other data set like it.”
Next Wave for CAR T-Cell Therapy Brings Off-the-Shelf, Multiple Myeloma Therapies [AJMC] Successors to the first generation of chimeric antigen receptor (CAR) T-cell treatments will attack multiple targets and address the complexity of the manufacturing process by bringing uniformity to the creation of therapies.
Janssen Presents Initial Results for BCMA CAR-T Therapy JNJ-4528 Showing Early, Deep and High Responses in the Treatment of Relapsed or Refractory Multiple Myeloma [Janssen] Results from the Phase 1b portion of the CARTITUDE-1 study showed early and deep responses among patients (n=29) with a median of five prior multiple myeloma treatment regimens (range, 3-18) treated with JNJ-4528 (median administered dose 0.73x106 CAR+ viable T cells/kg), with 100 percent of patients achieving a response (95 percent confidence interval [CI], 76-95) at a median six-month follow-up.
J&J team shows off 'breakthrough' BCMA CAR-T data, and that could cause a big headache at bluebird and Bristol-Myers [EndPoints] Bluebird and Bristol-Myers attempted to steal some of the CAR-T thunder at ASH this year with a release on ide-cel just ahead of the confab. But they’re having trouble with durability when it comes to the excitement level.
Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from the Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma [BMS] Study met its primary endpoint and key secondary endpoint, demonstrating deep and durable responses in a heavily pre-treated multiple myeloma patient population.
	5.8.6 ASH - LEUCÉMIES
IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) [AbbVie] New results from the Phase 2 CAPTIVATE clinical trial show the potential of this fixed-duration, combination therapy for CLL patients starting treatment for the first time.
	5.8.6.1 ASH - LEUCÉMIES - ACALABRUTINIB
ASH: AstraZeneca's Calquence posts sky-high survival numbers in previously untreated CLL [FiercePharma] That same study, dubbed Elevate-TN, showed the Calquence-Gazyva pairing could cut patients’ risk of disease progression or death by 90% and that Calquence monotherapy could slash the same risk by 80%.
Calquence significantly prolonged the time patients lived without disease progression or death in previously untreated chronic lymphocytic leukaemia [AstraZeneca] Full results from the Phase III ELEVATE TN trial showed 93% of patients on Calquence combined with obinutuzumab vs. 47% of patients on chlorambucil plus obinutuzumab remained free of disease progression or death at 24 months.
	5.8.6.2 ASH - LEUCÉMIES - IBRUTINIB
Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL) [AbbVie] Data featured at the 2019 American Society of Hematology (ASH) Annual Meeting further supports IMBRUVICA as the most comprehensively studied Bruton's tyrosine kinase inhibitor, with 10 FDA approvals and 170,000 patients treated worldwide.
IMBRUVICA® (ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leukemia [Janssen] Results from a 48-month follow-up analysis of the Phase 3 E1912 clinical study reported a statistically significant difference in PFS and OS for IMBRUVICA® plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR).
E1912 follow-up shows ibrutinib effective, well tolerated by majority of CLL patients [ECOG-ACRIN] Follow-up data from the phase 3 E1912 study shows previously untreated patients (aged 70 or younger) with chronic lymphocytic leukemia who received ibrutinib-based therapy lived longer and with sustained benefit, supporting the earlier trial findings.
	5.8.6.3 ASH - LEUCÉMIES - VENETOCLAX
ASH: AbbVie, Roche pad their case for fixed-duration Venclexta use in CLL [FiercePharma] With those efficacy numbers in tow, AbbVie and Roche are looking at the combination’s fixed duration as a positive for patients who don’t want constant reminders of their disease.
New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) [AbbVie] Sixty-eight percent of the 130 patients who completed the treatment course were free of disease progression and maintained OS benefit 24-months after being off therapy.
New data demonstrate the continued clinical benefit of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based treatments in chronic lymphocytic leukaemia [Roche] At four-year follow-up of the MURANO study, Venclexta/Venclyxto plus MabThera/Rituxan continued to reduce disease progression compared to a standard-of-care therapy in previously treated chronic lymphocytic leukaemia.
	5.8.7 ASH - LYMPHOMES
More than Seven-Year Analysis of Early Treatment with IMBRUVICA® (ibrutinib) Monotherapy Showed Improved Progression-Free Survival in Patients with Mantle Cell Lymphoma (MCL) that Relapsed or Were Unresponsive to Prior Regimen [AbbVie] The updated pooled analysis includes three clinical trials: Phase 2 SPARK, Phase 3 RAY and Phase 2 PCYC-1104.
MSK Experts Report Advances in Lymphoma Treatment at the 2019 ASH Meeting [Memorial Sloan Kettering Cancer Center] MSK medical oncologist Steven Horwitz presented findings from a phase 2 study testing cerdulatinib in 61 people with PTCL or CTCL that didn’t go away or came back after other treatments. The drug appears to be safe and somewhat effective in both lymphoma types, primarily in specific subtypes.
Lymphoma Patients May Have New Path to Remission, Even When CAR T Therapy Fails [Penn Medicine] A global, multi-center trial found almost half of patients with slow growing lymphomas had complete responses to the antibody called mosunetuzumab. Among patients on the study whose lymphoma progressed after CAR T therapy, 22 percent went into complete remission when treated with the drug.
Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study [BMS] Data from the pivotal liso-cel TRANSCEND NHL 001 study demonstrate patients with relapsed/refractory large B-cell lymphomas experienced high rate of durable responses.
Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment [Gilead] Separate Cohort Finds Earlier Steroid Use May Reduce Risk of Severe Cytokine Release Syndrome and Neurologic Events.
Bristol-Myers reports positive data on cancer treatment acquired in Celgene deal [Reuters] The study tested three dose levels of liso-cel in the 269 patients with relapsed or refractory large B-cell lymphoma.
Half of lymphoma patients alive three years after Gilead cell therapy treatment: study [Reuters] Out of 101 patients teated with Yescarta for an aggressive blood cancer known as refractory large B-cell lymphoma in the study, 47 were still alive at least three years later, the data presented at the American Society of Hematology meeting in Orlando showed.
	6. LUTTE CONTRE LES CANCERS
'Holy grail' of cancer cure hides progress made, says charity [The Guardian] The average patient now lives more than 10 years after diagnosis, turning it into a manageable disease long term. But only 28% of people believe cancers can be controlled long term, and 26% think major progress is being made against the disease, the poll – conducted by YouGov – found.
Cancer research offers more hope than people think [Institute of Cancer Research] The ICR commissioned polls of 2,103 members of the public and 355 people who have been treated for cancer to inform the development of its new Centre for Cancer Drug Discovery by assessing public understanding of the major challenge of cancer evolution and drug resistance.
	6.10.1 POLITIQUES (USA)
Labor Unions Team Up With Drug Makers to Defeat Drug-Price Proposals [NY Times] A low-profile group, financed by the pharmaceutical industry, has hired former union officials to oppose drug-price proposals around the country.
	6.11 PATIENTS
‘I’m more stressed about my money than my cancer’: the hidden cost of living with a serious illness [The Telegraph] About 10,000 people in Britain are diagnosed with the cancer each year. The debilitating nature of the illness leaves many unable to work, potentially driving them into debt and financial ruin.