Onco Actu du 3 avril 2019

	3.3 PRÉVENTION - VACCINS
Court ruling highlights the threat of vaccine misinformation [Nature] On 26 March, a court in Tokyo ruled that Muranaka had defamed a medical scientist who claimed that the HPV vaccine could cause brain damage. Although the case against Muranaka was confined to a single charge of libel and did not address the underlying science, the repercussions of the ruling are cause for concern.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices [FDA] We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained.
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback [Regulations.gov] This discussion paper describes an innovative approach that may require additional statutory authority to implement fully. The proposed framework is being issued for discussion purposes only and is not a draft guidance.
FDA developing new rules for artificial intelligence in medicine [STAT] The white paper describes criteria the agency proposes to use to determine when medical products that rely on artificial intelligence will require FDA review before being commercialized.
	5.10 TRAITEMENTS - ESSAIS
Combination of PARP inhibitor and targeted therapy significantly outperforms PARP inhibitor alone in patients with chemotherapy-resistant ovarian cancer [Dana-Farber Cancer Institute] The results of the phase I trial, which combined the PARP inhibitor olaparib with alpelisib, an investigational drug that targets the cell protein PI3-Kinase alpha, are reported online in the journal The Lancet Oncology.
	5.12 IMMUNOTHÉRAPIES
Scientists prod immune cells to attack pancreatic cancer [UW Medicine] Results challenge the view that immunotherapies are unlikely to be effective against this deadly cancer, the researchers say.
Gut Microbiome Directs the Immune System to Fight Cancer [Sanford Burnham Prebys] The RNF5-lacking mice were able to inhibit the growth of melanoma tumors, provided they had an intact immune system and gut microbiome. Treating these mice with a cocktail of antibiotics or housing the mice with their regular (wildtype) littermates abolished the anti-tumor immunity phenotype and consequently, tumor rejection—indicating the important role of the gut microbiome in anti-tumor immunity.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
FDA Clears the IND for UCARTCS1, the First Allogeneic CAR-T to Treat Multiple Myeloma Patients [Cellectis] UCARTCS1 is the first allogeneic CAR-T therapy for MM to enter clinical development.
The Next Frontier of CAR T-Cell Therapy: Solid Tumors [The Scientist] The technology has wowed the field by all but obliterating some patients’ blood cancers, but solid malignancies present new challenges.
	5.2.3 PHARMA - ÉCONOMIE
OrbiMed, Varian lead $105M round for targeted radiotherapy outfit Fusion Pharma [Fierce Biotech] The company believes that its linker technology—which connects a molecule to a radioactive compound—can clear radiotherapeutics more quickly than commercially available linkers, thereby extending their therapeutic window.
Laser-activated eye cancer drug developer Aura Biosciences scores $40M in Medicxi-led round [EndPoints] The company’s sole drug, AU-011, consists of viral nanoparticles modeled on HPV and is conjugated to infrared-activated small molecules. It is being developed for ocular melanoma (OM), the most common primary cancer of the eye.
Another day, another $100M-plus biotech megaround as radiopharmaceuticals’ popularity grows [EndPoints] Their lead drug, now sitting on the threshold of Phase I, uses an antibody to guide alpha-particle emitting medical isotopes to cancer cells, creating a kind of flash grenade of localized radiation to kill malignant cells.
	5.9 AACR
AACR Annual Meeting 2019: Recent Progress For Patients With Hard-to-treat and Rare Cancers [Cancer Research Catalyst] Death rates for some types of cancer, such as esophageal cancer, have increased in certain populations, and pancreatic cancer is projected to become the second leading cause of cancer-related mortality in the United States by 2030. To address these areas of unmet clinical need, several presentations at the AACR Annual Meeting 2019 focused on clinical trials in patients with rare or hard-to-treat tumor types.
AACR Annual Meeting 2019: Plenary Examines Global Issues in Cancer [Cancer Research Catalyst] The AACR Annual Meeting 2019 features the theme “Integrative Cancer Science • Global Impact • Individualized Patient Care.” That theme provided the structure for Monday’s plenary session, when cancer researchers representing three continents, four cancer types, and diverse areas of interest took the stage.
	5.9.1 AACR - SEIN
Surgery is Associated With Increased Survival for Patients With HER2+ Stage 4 Breast Cancer [AACR] To assess the impact of primary tumor resection on survival in HER2+ stage IV breast cancer patients, they conducted a retrospective cohort study of 3,231 women with the disease, using records from the National Cancer Database from 2010 to 2012.
	5.9.12 AACR - BIOPSIES LIQUIDES
Liquid Biopsy Early Cancer Experiments Presented at AACR Demonstrate Diversity of Methods [Genome Web] In a scientific session at the annual meeting of the American Association for Cancer Research on Sunday, investigators presented data from a diverse set of efforts as audience members and session leaders discussed the challenges that various approaches may face in advancing to the clinic.
Exosomes from Blood Carry RNA Signatures of Liver Cancer [The Scientist] The team presented data on 15 patients at AACR and are hoping to sequence the exosomes from a total of 150 volunteers to see if the trend is consistent. Along with developing better screening methods, the scientists hope that understanding the makeup of these exosomes may lead to new therapies.
	5.9.13 AACR - PANCRÉAS
AACR: Clovis' Rubraca follows Lynparza's big pancreatic cancer win with phase 2 data [Fierce Pharma] While the data are “extremely preliminary” and researchers need more analysis to validate the findings, they still represent “a very exciting, kind of groundbreaking signal” that patients in this pool “might indeed respond to single-agent PARP inhibition therapy,” said lead investigator Kim Reiss Binder, M.D.
Early pancreatic cancer data give Clovis a new path in PARP market [Biopharma Dive] The single-arm study is set up to enroll 42 patients to test whether Rubraca could serve as a less toxic maintenance option following chemotherapy. So far, 30 patients have been recruited, although only data from 19 were ready for analysis.
PARP Inhibitors Can Shrink Tumors in Pancreatic Cancer Patients with Specific Mutations [Penn Medicine] The results are from a study evaluating this therapy in patients with BRCA1, BRCA2, or PALB2 mutations and provides encouraging early evidence that this approach might control cancer growth in patients who carry these genetic mutations.
Maintenance Therapy With Rucaparib Shows Clinical Responses in a Subgroup of Patients With Pancreatic Cancer [AACR] Nineteen of the 24 enrolled patients were evaluable for analysis as of Dec. 31, 2018. The median PFS at time of analysis was 9.1 months following initiation of rucaparib treatment. The ORR was 37 percent, which included one complete response (CR) and six partial responses (PR).
	5.9.2 AACR - HÉMATO
Astellas' AML therapy bests chemo in Phase 3 study [Biopharma Dive] The median overall survival for patients who received Xospata was 9.3 months compared to 5.6 months for patients who received second-line chemotherapy.
	5.9.4 AACR - POUMON
Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients [BMS] In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 ≥1% and <1%, four-year overall survival (OS) rates were 19% and 11%, respectively.
	5.9.6 AACR - PROSTATE
Prostate Cancer Incidence and Mortality Have Declined in Most Countries [AACR] "Future studies should monitor trends in mortality rates and late-stage disease to assess the impact of reduction in PSA testing in several countries."
Prostate cancer diagnoses, deaths decreasing worldwide, study says [CNN] Prostate cancer diagnosis rates decreased in seven countries from 2008 to 2012, and 33 countries showed a stabilization in diagnosis rates, the study found. From 2008 to 2012, the United States had the greatest decrease in the number of men diagnosed with prostate cancer.
	5.9.7 AACR - DIVERS
Combined Analysis of DNA, RNA Gaining Popularity in Pediatric Cancer Research [Genome Web] At the AACR annual meeting in Atlanta yesterday, Co-Executive Director of the Institute for Genomic Medicine at Nationwide Children's Hospital Elaine Mardis detailed her center's efforts to combine DNA and RNA sequencing in the clinical cancer care setting in order to help patients.
Combination of Virotherapy and Radiotherapy Safe, Shows Early Promise in Vulnerable Patients With Esophageal Cancer [AACR] In this open-label, phase I dose-escalation trial, the investigators enrolled 13 patients with histologically confirmed esophageal cancer deemed unfit to receive standard surgery or chemotherapy.
A Genetic Variant Linked to Increased Risk of Stroke in Childhood Cancer Survivors Treated With Cranial Radiation Therapy [AACR] Sapkota and colleagues analyzed whole-genome sequencing data from 686 childhood cancer survivors treated with CRT for their primary cancer from the St. Jude Lifetime Cohort (SJLIFE) study; all survivors in this analysis were of European descent.
Adults at High Risk for HIV Infection Have Low Rates of Vaccination Against Human Papillomavirus [AACR] Wigfall said one potential reason for the low rate of vaccination in high-risk populations is that recommendations for people living with HIV were issued several years after the HPV vaccine first became available to the general population.
	5.9.8 AACR - PHARMA
AACR 2019 – Vitrakvi relapse findings justify Bayer’s interest [Evaluate] Dr. Hyman stressed that the AACR data suggested that LOXO-195 could eventually become a meaningful treatment for subjects whose cancers are resistant to first-generation TRK inhibitors. Bayer will no doubt be keen to point out that one such drug is entrectinib.
	5.9.9 AACR - IMMUNOTHÉRAPIES
Rubius Therapeutics Announces Extensive Preclinical Data for Three Red Cell Therapeutic Oncology Programs at the 2019 American Association for Cancer Research Annual Meeting [Rubius] RCT™ oncology product candidates are engineered to express combinations of co-stimulatory molecules and cytokines on the cell surface in their natural conformation that directly engage T and NK cells to activate the adaptive and innate immune systems through direct cell-cell interaction, replicating how the immune system naturally functions, to attack and kill tumors.
Probiotics are touted as good for the gut. They may be trouble for the immune system [STAT] The latest cautionary note comes in the form of a preliminary study released Tuesday, in which researchers found that melanoma patients were 70 percent less likely to respond to cancer immunotherapy if they were also taking probiotic supplements.
	6. LUTTE CONTRE LES CANCERS
Offbeat approaches to cancer research [Nature] Scientists are making advances through a variety of research methods; here, five individuals share how they’ve built careers in cancer research while taking innovative approaches to this problem.
	6.10 POLITIQUES
Brexit has already irreparably damaged research [Nature] The disastrous process of leaving the European Union is creating casualties of science and communities.
	6.12 ETHIQUE
Duke University’s huge misconduct fine is a reminder to reward rigour [Nature] The problem is that impact has become a means to an end. Ethics training and severe punishments don’t change incentives to cherry-pick results — or worse. Misconduct will be difficult to eradicate without cultural changes to shift rewards and increase safeguards.
	6.7 DMP, BIG DATA & APPLIS
Varian ARIA® Oncology Information System Awarded CancerLinQ Certification [ASCO] ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.