Onco Actu du 20 décembre 2018

	1. Biologie
FSU researchers identify ways breast cancer avoids immune system detection [Florida State University] The team broke the data down into different groups and identified seven clusters of breast cancer patients based on the immune evasion mechanisms that breast cancer uses to avoid detection. Some of the types even used a combination of ways to hide from the immune system.
Immune cells cast DNA ‘webs’ that may help ovarian cancer spread [Cancer Resarch UK] Researchers from the University of Texas found that ovarian cancer cells spread to new tissue in mice after being caught in DNA webs released by specialised immune cells, called neutrophils.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
Recommendations by UK's NICE [Genome Web] Meanwhile, NICE did not recommend Agendia's MammaPrint for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2‑negative, and lymph node-negative early breast cancer, deciding it is not cost effective. Also, NICE did not recommend IHC4+C for this purpose "because the analytical validity of the test is uncertain."
Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer [NICE] EndoPredict (EPclin score), Oncotype DX Breast Recurrence Score and Prosigna are recommended as options for guiding adjuvant chemotherapy decisions for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer, only if...
United Kingdom’s National Institute for Health and Care Excellence (NICE) Recommends NanoString’s Prosigna Breast Cancer Gene Signature Assay to Guide Chemotherapy Treatment Decisions for Qualified Early-Stage Invasive Breast Cancer Patients [nanoString] “NICE’s recommendation of Prosigna is an important milestone in achieving in-country delivery of personalized medicine to breast cancer patients in England.”
	4.7 Dép., diag. & prono. - Col de l'utérus
Too soon to say cervical cancer DNA test will ‘revolutionise screening’ [Cancer Research UK] The new test correctly found the most advanced pre-cancerous cell changes in 93 in 100 samples on average, compared with 86 in 100 advanced pre-cancerous cell changes that were detected using a combination of HPV testing and cytology. Based on statistical tests, the researchers couldn’t rule out whether or not this difference was just down to chance.
	5. Traitements
Pancreatic cancer [NICE] This quality standard covers diagnosis of pancreatic cancer and management of pancreatic ductal adenocarcinoma in adults aged over 18. This quality standard describes high-quality care in priority areas for improvement. It does not cover national initiatives, such as cancer screening or audit.
	5.10 Traitements - Essais
Lynparza meets primary endpoint in Phase III SOLO-3 trial for the treatment of relapsed BRCA-mutated advanced ovarian cancer [AstraZeneca] “We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed. We look forward to sharing the full results at a forthcoming medical meeting.”
Whole- and Partial-Breast Radiation Effective at Preventing Breast Cancer from Returning [NCI] In the randomized clinical trials, both whole-breast irradiation (WBI) and accelerated partial-breast irradiation (APBI) were associated with low rates of the cancer recurring in the breast where the disease originally developed. The median follow-up ranged from more than 5 years to more than 10 years.
AstraZeneca's ovarian cancer and anemia treatments meet goals in late-stage studies [Reuters] AstraZeneca said it plans to discuss results of the Lynparza study with the U.S. Food and Drug Administration, which has already approved Lynparza as a first-line maintenance treatment for adults with a form of ovarian cancer.
	5.12.3 Immunothérapies-combinaisons
Vaccine, Checkpoint Drugs Combination Shows Promise for Pancreatic Cancers [Johns Hopkins] The findings showed by using PancVAX with the checkpoint drugs, pancreatic tumors had a better response to therapy by converting T cell-poor tumors into tumors that are rich in specific T cells. T cells are critical cells of the immune system to recognize and kill cancer cells.
	5.12.6 Immunothérapies - AMM
FDA approves pembrolizumab for Merkel cell carcinoma [FDA] Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multicenter, non-randomized, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease.
	5.12.7 Immunothérapies - vaccins
Anticancer Vaccines Gain new Lease of Life with Personalisation Techniques [ESMO Press Release] “We are counting on new technologies that have now matured. Next generation sequencing has made identification of vaccine targets more efficient, reliable, and cheaper. The algorithms to interpret this data are benchmarked and validated for predicting which targets are most likely to be immunogenic. Sequencing technologies are only going to get better and prediction tools will become even more accurate.”
	5.2.1 Pharma - Partenariats
Expect more transparency around pharma's advocacy group partnerships in 2019 [FiercePharma] "Instead of seeing these widespread calls for transparency as a reason to retreat, it is wiser to view them as a reminder of two simple truths: transparency is the key to trust and trust is the most important currency we have as an industry."
	5.2.3 Pharma - économie
The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more? [FiercePharma] The levels of those substances found in some drugs exceeded those scientists say are safe, and the findings have pushed the FDA to dive deep into their cancer risks. While the risk is low, the agency has said, it is still a risk. Among patients who have taken the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer in 8,000 people.
	5.3 Traitements - FDA, EMA, NICE...
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics - Guidance for Industry [FDA] This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.
	5.3.4 Traitements - AMM (FDA, EMA,...)
FDA approves olaparib for first-line maintenance of BRCA-mutated advanced ovarian cancer [FDA] Approval was based on SOLO-1 (NCT01844986), a randomized, double-blind, placebo-controlled, multi-center trial that compared the efficacy of olaparib with placebo in patients with BRCA-mutated (BRCAm) advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line platinum-based chemotherapy.
BRACAnalysis CDx® Approved by U.S. Food and Drug Administration as Companion Diagnostic for AstraZeneca’s Lynparza® (olaparib) in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer [Myriad] Lynparza is being commercialized by AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada). The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.
Lynparza approved by US FDA for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer [AstraZeneca] First PARP inhibitor approved in 1st-line maintenance for BRCAm advanced ovarian cancer.
	5.4 Traitements - Economie
NICE recommends Lenvima as alternative first-line therapy for advanced liver cancer [Pharmafile] Lenvima provides another first-line treatment option for the condition, and is thought to benefit around 900 patients a year.
Lenvatinib for untreated advanced hepatocellular carcinoma [NICE] Lenvatinib is recommended as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, only if: they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides it according to the commercial arrangement.
	6.1 Observation
Prostate cancer scoring method may underestimate mortality risk in black men [Dana-Farber Cancer Institute] The death rate – while low – was almost double in the black men with Gleason 6 disease, even after accounting for socioeconomic status and treatment patterns.
	6.10.1 Politiques (USA)
Is a God-fearing scientist the next casualty of the Trump White House? [Washington Examiner] Anti-abortion advocates want President Trump to fire Dr. Francis Collins, the wildly popular, Obama-appointed head of the government’s medical research agency.
	6.12 Ethique
Top Cancer Doctor Resigns as Editor of Medical Journal [NY Times] Dr. José Baselga, the former chief medical officer of Memorial Sloan Kettering Cancer Center, resigned under pressure on Wednesday as one of the editors-in-chief of Cancer Discovery, a prominent scientific journal, after he failed to accurately disclose his conflicts of interest in dozens of articles in medical journals.
	6.2 Implants mammaires
Breast implants linked to cancer withdrawn from sale in Europe [The Guardian] French authorities withdraw approval for Allergan textured implants, popular in UK.
	6.6 Publications
University of California squares off against major publisher, with big stakes for access to research [STAT] This is all coming to a head now because UC’s current five-year contract with Elsevier is set to expire on Dec. 31. UC and Elsevier have spent months in negotiations — and both sides are playing hardball.
Plan S: The Ambitious Initiative to End the Reign of Paywalls [The Scientist] A funder-driven push for freely accessible scholarly literature has divided the scientific community.
	6.8 Communication
No peak in sight: Cancer marketing spreads across media landscape, from TV to digital [FiercePharma] Messaging may evolve as marketing spreads to diverse media and more targeted drugs get into the game. Ads aimed to niche groups of doctors or patients who might use the more specialized cancer treatments will have a more personalized tone than mainstream ads meant to appeal to mass audiences.