Onco Actu du 18 janvier 2019

	1. BIOLOGIE
Scientists learn how common virus reactivates after transplantation [Fred Hutchinson] A new study in Science challenges long-held theories of why a common virus — cytomegalovirus, or CMV — can reactivate and become a life-threatening infection in people with a compromised immune system, including blood cancer patients undergoing bone marrow transplantation.
	5. TRAITEMENTS
Proteus Digital Health® Launches Digital Oncology Medicines to Improve Patient Outcomes [Proteus] Proteus developed the care model for oral digital oncology medicines with University of Minnesota Health and Fairview, which is the first health system in the world to prescribe digital capecitabine, a common chemotherapy drug prescribed with the Proteus ingestible sensor. Currently it is being used to help treat stage 3 and 4 colorectal cancer patients.
A ‘digital pill’ for cancer patients is rolled out for the first time, in hopes of improving outcomes [STAT] The idea is that, by tracking when patients take their drugs, health care providers will be better able to ensure medication adherence and to provide treatment guidance, with the goal of improving health outcomes.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Engineered immune cells target broad range of pediatric solid tumors in mice [Stanford] The team is now planning a series of phase-1 clinical trials for the B7-H3 CAR-T cells, starting with adult brain tumor patients. B7-H3 is not expressed on healthy tissues in the central nervous system, making it a good starting point for human trials.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application [Immunomedics] “We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”
FDA rejects Immunomedics breast cancer drug, extending long regulatory drought [STAT] The FDA rejection is a setback for Immunomedics, one the industry’s oldest companies — in operation for 37 years without ever securing a drug approval.
Immunomedics' cancer treatment fails to win accelerated approval from the FDA [Reuters] The company said it will request a meeting with the agency and work closely with the health regulator in its effort to launch the treatment (sacituzumab) as soon as possible.
	5.2.2 PHARMA - FUSIONS & ACQUISITIONS
Lilly rushed its Loxo deal to have a big reveal at JPM [Biopharma Dive] Lilly representatives wanted to "expeditiously" complete due diligence and execute a transaction to meet the JPM timeframe, according to Loxo. Deal talks began and concluded in about a two-week window.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
EU licence granted for Erleada in prostate cancer [Pharma Times] The decision is based on the results of the Phase III SPARTAN trial, which found that Erleada (apalutamide), in combination with Androgen Deprivation Therapy (ADT), significantly decreased risk of death or distant metastasis by 72%.
	5.4 TRAITEMENTS - ECONOMIE
Lilly price break reverses NICE’s 'No' ruling on breast cancer drug Verzenio [Fierce Pharma] With a new price break from Lilly, Verzenio is now as good a deal as Ibrance and Kisqali are, NICE ruled. The three drugs “have different side effects, but they all appear to work as well as each other,” NICE said in its guidance document.
NICE approval for Verzenios in metastatic breast cancer [Pharma Times] Following an improved patient access scheme for Verzenios, it is now considered cost effective by the Institute and thus has been recommended as an option for these patients, meaning that they will be able to access the drug immediately. Verzenios is one of a new type of drug called a CDK4/6 inhibitor.
Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptorpositive, HER2-negative, locally advanced or metastatic breast cancer [NICE] Abemaciclib is recommended only if the company provides it according to the commercial arrangement.
Thousands of adults with chronic lymphocytic leukaemia to benefit from new treatment option [NICE] Thousands of people will benefit as NICE recommends venetoclax with rituximab for adults with relapsed or refractory chronic lymphocytic leukaemia.
	5.5.5 ASCO (GASTRO-INTESTINAL)
2019 Symposium to Highlight Notable Research Advances in Gastrointestinal Cancers [ASCO] Five noteworthy studies exploring new approaches in the treatment and management of liver, esophageal, colorectal, and colon cancers will be presented at the 2019 Gastrointestinal Cancers Symposium, taking place January 17-19, 2019 at the Moscone West Building in San Francisco, California.
	6.1 OBSERVATION
Breast cancer up to five times more likely to metastasise even 10 years after childbirth [ecancerNews] The increased risk for metastasis was highest in the women up to ten years postpartum and was most pronounced in women with stage I or II breast cancer, with a 3.5-to-5 times higher risk than women with similar, non-pregnancy associated cancers.
Long-lasting menopause symptoms may be tied to slightly higher breast cancer risk [Reuters] They also pointed out that obesity, alcohol use, breast density and having never been pregnant are all associated with well documented and far more substantial risks of breast cancer. Unlike the duration of menopause symptoms, they noted, “These risk factors are not only important but (in the case of) obesity and alcohol use are modifiable.”
	6.10.1 POLITIQUES (USA)
Patient and medical groups blast Trump administration drug pricing proposal in new ad campaign [STAT] “When you limit drug therapies, you threaten lives,” reads the headline of the advertisement. It goes on to say the policy “could interfere with what doctors think is the best course of treatment for their patients and if finalized, could delay patients’ access to lifesaving innovative therapies.”
“Right to try” laws create tremendous legal uncertainties; FDA expanded access preferable [Science-Based Medicine] The “right-to-try” movement was fueled by the Goldwater Institute and the Koch brothers (at the suggestion of the CAM-friendly Cancer Treatment Centers of America) who were looking for a stick with which to poke the FDA in the eye and apparently not overly concerned with how the process would play out in actual practice.
	6.12 ETHIQUE
Tackling legal and ethical challenges that big data brings [ESMO] A paper published in the Nature Medicine on 7 January 2019 outlines the legal and ethical challenges that big data brings in terms of patient privacy. Topics discussed include the concept of health privacy, the importance of equity, consent, and patient governance in data collection, discrimination in data uses, how to handle data breaches and possible ways forward for the regulatory system.
	6.7 DMP, BIG DATA & APPLIS
Novartis teams up with Oxford researchers to crunch big data into clinical insights [EndPoints] "We are spending a lot of our energy just trying to get all of our data harmonized, so that some algorithm could maybe find anything of use." It appears that Novartis is now ready to dive into that lake with the help of an esteemed academic partner.
	6.7.3 DMP
Report: Study shows promise of Apple’s Health Records service [Fierce Biotech] Widespread use of electronic databases has been difficult for hospitals due to complicated technology interfaces, privacy and coordination of sometimes multiple information platforms, however, with the increased adoption of mobile platforms by consumers, the trend may be moving toward such use.