Onco Actu du 4 mars 2019

	2. ETIOLOGIE
FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall [FDA] Recent FDA analyses of NDMA and NDEA in recalled valsartan found that overall, the risk to individual patients is very low, although this doesn’t diminish the significance of this issue or the FDA’s concerns. The agency continues to evaluate the risks nitrosamines pose to patients.
New cancer-causing toxin found in recalled blood pressure pills [Reuters] The toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero’s losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.
	3.1 PRÉVENTION - TABAC
Quebec appeals court upholds C$15 billion tobacco class action ruling [Reuters] The two Quebec suits, called the Letourneau and Blais cases, were filed in 1998 and certified as class actions in 2005. They were consolidated into one before the 2012 start of trial proceedings, which ended in 2014.
Tobacco companies will pay out $17B to smokers after losing appeal [CTV Montreal] In June 2015, Quebec Superior Court Justice Brian Riordan ordered the companies to make payments of more than $15-billion to smokers who either fell ill or were addicted. At the time, the ruling was believed to be the biggest class action award in Canadian history.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Electronic cigarettes: a task force report from the European Respiratory Society [European Respiratory Journal] There is not enough scientific evidence to support ECIGs as an aid to smoking cessation due to a lack of controlled trials, including those that compare ECIGs with licenced stop-smoking treatments. So far, there are conflicting data that use of ECIGs results in a renormalisation of smoking behaviour or for the gateway hypothesis.
	4. DÉPISTAGE, DIAGNOSTIC ET PRONOSTIC
Protein content as a marker for response to therapy in brain cancer [DKFZ] 7-Tesla MRI machines of the type that was used for the present study are only available at a small number of research locations. Fewer than 100 of these scanners, which weigh 25 tons and cost over €10 million, are running worldwide.
	4.12 BIOPSIES LIQUIDES
Liquid biopsy is as effective as tissue biopsy in lung cancer, study finds [Biopharma Dive] The FDA has so far only approved one blood-based cancer test, which detects mutations in the EGFR gene in non-small cell lung cancer patients. Such mutations are present in about 10% to 20% of these patients. The test, marketed by Roche, was approved in 2016.
	5. TRAITEMENTS
Investigators map genomic landscape of very rare cancer [Vanderbilt University Medical Center] A team of Vanderbilt researchers mapped out the genomic landscape of a metastatic malignant proliferating tricholemmal tumor and identified a targeted treatment for this very rare cancer. The patient case report, published recently in npj Precision Oncology, was only the 28th instance of the cancer documented in medical literature and the first instance where genotyping occurred.
	5.10 TRAITEMENTS - ESSAIS
ImmunoGen’s ADC misses endpoint in ovarian cancer phase 3 [Fierce Biotech] Mirvetuximab soravtansine numerically outperformed the control in a prespecified high folate receptor alpha subgroup. But the failure of the overall study and statistical approach used meant the p value of 0.049 was above the threshold for success.
ImmunoGen's lead therapy misses in Phase 3, tanking shares [Biopharma Dive] ImmunoGen, a Waltham, Massachusetts-based biotech founded in 1981, has racked up an accumulated deficit of roughly $1.1 billion and still has no product revenue, according to its last quarterly filing with the Securities and Exchange Commission.
ImmunoGen Announces Top-Line Results from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine in Ovarian Cancer [ImmunoGen] Trial Did Not Meet Primary Endpoint of Progression-Free Survival.
ImmunoGen drug fails cancer study, shares slide 40 percent [Reuters] While the drug was tested as a standalone treatment in this instance, ImmunoGen is also evaluating it in combination with other therapies, as well as developing other drugs for different forms of cancer.
	5.12.1 IMMUNOTHÉRAPIES - PARTENARIATS
Abpro bags $60M in near-term R&D cash in tie-up with China’s NJCTTQ, with eyes on bispecific T cell engagers [EndPoints] With the promise to latch T cells onto the tumor antigens of choice, bispecifics are emerging as the next big breakthrough in cancer immunotherapy hot on the heels of CAR-T, inspiring big bets from the likes of Amgen and Genentech.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Gilead’s Kite pens 10-target CAR-T tech deal with MaxCyte [Fierce Biotech] The quick decision to expand the agreement suggests Kite, like other companies before it, was won over by the technology. MaxCyte’s platform uses an electrical field to reverse the permeability of cell membranes and enable molecules to pass into the cell, eliminating the use of chemicals or viruses.
	5.12.9 IMMUNOTHÉRAPIES - SITC
2019 Symposium Features Noteworthy Research on Immunotherapy for Cancer [ASCO] Nine studies exploring a variety of trends and approaches in immuno-oncology, including adaptive cell therapies, immune checkpoint inhibitors, the use of predictive biomarkers, and more, were presented at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.
	5.2.2 PHARMA - FUSIONS & ACQUISITIONS
Big Pharma’s Hunt for New Drugs Is Pushing Up Cost of Deals [NY Times] Competition for the takeover targets, however, has also meant big pharma companies are having to pay high prices. That is being reflected in the premiums being offered in the deals this year.
Can BMS rebels scuttle its Celgene buy? Analysts do the math—and so far, the votes don't add up [Fierce Pharma] Only “aggressive shareholder activism” could derail the merger, he said—and that would most likely have to come in the form of a bidder swooping in to take out Bristol-Myers before the Celgene deal wraps up. That scenario has come up many times since BMS announced the Celgene buy earlier this year. Bristol-Myers has been under pressure from investors unhappy that its immuno-oncology blockbuster, PD-1 inhibitor Opdivo, has been losing ground to Merck & Co.’s Keytruda.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Roche wins US approval of more convenient Herceptin [Biopharma Dive] The regulatory thumbs up could help Roche to keep sales from its HER2 breast cancer franchise up in the U.S., where biosimilar competitors to Herceptin are expected to launch later this year. Three of the copycat biologics are already approved by the FDA.
Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer [Pfizer] The Marketing Authorization Application (MAA) for LORVIQUA was based on results from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multi-center Phase 1/2 study, B7461001, evaluating LORVIQUA for the treatment of patients with ALK-positive advanced NSCLC, who were previously treated with one or more ALK TKIs.
Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer [AstraZeneca] OlympiAD was a global, randomised, open-label, multi-centre Phase III trial of 302 patients, assessing the efficacy and safety of Lynparza tablets (300mg twice daily) compared to the physician’s choice of chemotherapy (capecitabine, eribulin or vinorelbine); 205 patients were randomised to receive Lynparza and 97 patients were randomised to receive chemotherapy.
FDA Approves New Formulation of Herceptin for Subcutaneous Use [ESMO] Approval is based on results from two randomised trials, HannaH and SafeHER.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019 [EMA] The CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Lorviqua (lorlatinib), for the treatment of patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer.
	5.9 AACR
Media Gets Sneak Peek at Annual Meeting Scientific Presentations [Cancer Research Catalyst] These studies reflect key scientific topics from this year’s meeting: precision medicine, immunotherapy, health disparities, and clinical trials.
	6.6 PUBLICATIONS
California Tells Elsevier to Take a Hike [In The Pipeline] This is a big move. The California system accounts for about 10 per cent of all the scientific publications in the US, and they are definitely the largest US academic defection from Elsevier journals.
	6.7 DMP, BIG DATA & APPLIS
'Information Blocking' Plan Seeks to Free Data for Precision Medicine [Genome Web] The proposals actually follow a model being tested in the Sync for Genes pilot program. Sync for Genes is an extension of a data standardization effort called Sync for Science, which itself is part of the National Institutes of Health's All of Us research program.
	6.7.1 IA/BIOINFORMATIQUE
The A.I. Diet [NY Times] For now, it’s striking that it took big data and A.I. to reboot our perceptions about something as fundamental as what we eat. We’re still a ways away from “You Paleo, me Keto,” but at least we’re finally making progress, learning that there is no such thing as a universal diet.