Onco Actu du 13 mars 2019

	1. BIOLOGIE
The tumor as organizer model [Science] As they grow, tumors evolve multiple subclones with divergent genetic and epigenetic features and distinct repertoires of stromal-recruiting factors. But, unlike embryonic organizers, which are evolutionarily preprogrammed, tumor organizers are shaped by genetic and epigenetic events selected during tumor progression.
	2.6 ETIOLOGIE - ENVIRONNEMENT
Bayer Roundup cancer trial goes to jury after closing arguments [Reuters] If the jury finds Roundup to have caused Hardeman’s cancer, the trial will proceed into a second stage, where his lawyers can present evidence allegedly showing the company’s efforts to influence scientists, regulators and the public about the safety of its products.
	3.1 PRÉVENTION - TABAC
Study evaluates mobile telephone interventions for socioeconomically disadvantaged smokers [CA: A Cancer Journal for Clinicians] When telephone‐delivered counseling was added to a program of standard nicotine replacement therapy (NRT) and text messaging support, the quit rate among socioeconomically disadvantaged smokers was more than double that of individuals receiving NRT alone.
	4.10 DÉP., DIAG. & PRONO. - POUMON
Artificial intelligence cuts lung cancer screening false positives [University of Pittsburgh] Comparing the model's assessment against the actual diagnoses of these patients, the researchers found that they would have been able to save 30 percent of the people with benign nodules from undergoing additional testing, without missing a single case of cancer.
	5.10 TRAITEMENTS - ESSAIS
FDA takes new steps to broaden patient participation in cancer clinical trials, advancing policies to promote inclusion of pediatric patients and patients with medical conditions that can occur alongside cancer [FDA] These guidances provide recommendations on how sponsors can safely and effectively broaden the criteria for the inclusion of certain patient populations in clinical trials, when appropriate, for pediatric patients, and patients with Human Immunodeficiency Virus, Hepatitis B and Hepatitis C Virus Infections, brain metastases, prior or concurrent malignancies or organ dysfunction.
	5.12.7 IMMUNOTHÉRAPIES - VACCINS
Vaccine for HER2 Breast Cancer Shows Early Promise [Duke Cancer Center] In a phase 1 clinical trial that enrolled 22 women with recurrent cancers that overexpress the HER2 protein, the vaccine demonstrated an ability to halt tumor growth and improve survival for a subset of patients. A phase 2 trial is being planned at Duke.
	5.2 PHARMA
Lilly's CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer [Lilly] Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.
Lilly's Cyramza scores in targeted lung cancer—but major competition awaits [Fierce Pharma] Even if it can snag them, entering the EGFR field will be no walk in the park. Plenty of rivals are already duking it out in that arena—not the least of which is AstraZeneca’s Tagrisso, which grabbed its first-line nod last April and rocketed to $1.86 billion in 2018 sales.
Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible [Janssen] Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot program.
Cyramza takes on Tarceva, but Tagrisso is the real opponent [Vantage] Unless the drug can beat Astra’s Iressa follow-on, Tagrisso, the success – reported today from Lilly’s pivotal Relay trial – will count for very little.
With Alimta patent cliff looming, Lilly plots stronger foothold in frontline NSCLC with Cyramza [EndPoints] This Phase III 449-patient trial, called RELAY, tested the Cyramza+Tarceva combo in previously untreated patients with EGFR-positive mutations.
Lilly's combo therapy succeeds in late-stage lung cancer study [Reuters] Cyramza, which made more than $800 million in revenue for Lilly in 2018, is approved in the United States to treat other forms of cancers, including stomach and another type of lung cancer.
	5.2.3 PHARMA - ÉCONOMIE
Backed by OrbiMed, Lilly and now Advantech, China’s InventisBio loads up $70M to propel cancer, metabolic pipeline [EndPoints] Benjamin Qiu, co-head of Healthcare Investment at Advantech, took the chance to highlight D-0502, an estrogen receptor degrader (SERD) for ER-positive breast cancer that’s brewing in Phase I as a “front-runner of similar products being developed globally.”
Top drugs and companies by sales in 2018 [Nature Reviews Drug Discovery] The continued achievements of Merck & Co.’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) in first-line lung cancer indications and other tumour types have seen it rocket from outside the top ten last year to number three this year.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Ned Sharpless, director of the National Cancer Institute, to be named acting FDA commissioner [STAT] Even from his post within the National Institutes of Health, Sharpless spoke often about how his agency could work with the FDA — and how, at NCI, his powers to better regulate and improve cancer care were limited.
NCI’s Ned Sharpless gets the nod to run the FDA in wake of Scott Gottlieb’s surprise exit [EndPoints] While not formally nominated, the move positions Sharpless as Gottlieb’s likely successor. If so, Sharpless won’t encounter much, if any, opposition in the biopharma industry.
NCI Director Norman Sharpless named acting FDA chief [Science] Physician-scientist has headed NCI for 17 months; Deputy Director Doug Lowy to serve as acting NCI director.
National Cancer Chief, Ned Sharpless, Named F.DA.’s Acting Commissioner [NY Times] Although Dr. Sharpless has been previously mentioned as a possible successor to Dr. Gottlieb, Mr. Azar said this is a temporary appointment and that the search for a permanent commissioner is underway. A successor must be nominated by President Trump and confirmed by the Senate.
National Cancer Institute chief to serve as acting FDA head [Reuters] Cancer experts and advocates praised the appointment of Sharpless as acting FDA chief after Gottlieb’s abrupt resignation earlier this month.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Pfizer's Herceptin biosimilar gets FDA approval as US entry nears [Biopharma Dive] Roche has a plan for extending Herceptin's profitable run. Just a couple weeks ago, the FDA approved a subcutaneous version of the cancer therapy, which has already been available in Europe for a number of years. That offering could help Roche sustain sales of its Herceptin offering even amid biosimilar competition.
	5.4 TRAITEMENTS - ECONOMIE
NICE u-turn backs use of Darzalex combo for myeloma relapse [Pharma Times] “While it is positive news that patients will now be able to access DVd, it is disappointing that NICE – despite recognising the life-extending, step-change this combination represents for patients – did not recommend routine access on the NHS.”
Asia Regulatory Roundup: India Expands Cost Controls for Cancer Drugs [RAPS] The changes impose a 30% trade margin cap on the products, resulting in price cuts of up to 87% on certain products.
Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma [NICE] It is recommended only if the conditions in the managed access agreement for daratumumab plus bortezomib plus dexamethasone are followed.
‘Game-changing’ myeloma drug combo approved for NHS use in England [Cancer Research UK] The combination will be paid for through the Cancer Drugs Fund. And will be an option for patients whose myeloma has got worse or come back after their first round of treatment.
	6.1 OBSERVATION
Does air pollution really kill nearly 9 million people each year? [New Scientist] The bigger picture is air pollution has been gradually falling over the decades in Europe due to tighter controls on vehicle emissions – though in some places a rise in wood burning is counteracting this trend. So air pollution contributed to far more deaths in the past – we just didn’t know about it.
Infertile women a fifth more likely to develop cancer in middle age [The Telegraph] Researchers stressed that the overall risk of cancer at this stage in life remained low. Overall, those with fertility problems had an absolute risk of 2 per cent, compared with that of 1.7 per cent among other women.
NI cancer rates increase by 15% [BBC News] Lesley Anderson of the NI Cancer Research Registry said the overall increase was largely due to the ageing population.
	6.10.1 POLITIQUES (USA)
President’s FY2020 Budget Threatens Progress Against Cancer, Patient Access to Care [ASCO] While we’re pleased that the President’s budget does include $50 million specifically for pediatric cancer research, any possible gains will be undermined by the nearly 15 percent proposed funding cut to both the NIH and the NCI overall.