Onco Actu du 19 novembre 2018

	2. Etiologie
Science Surgery: ‘Why do never-smokers get lung cancer?’ [Cancer Research UK] “Smokers can develop all types of lung cancers, although the association is stronger for small cell lung cancer and squamous cell carcinoma, whereas never-smokers are more likely to develop a non small cell lung cancer called lung adenocarcinoma,” says Jamal-Hanjani. There are also differences when you look at the DNA inside the tumour cells. Non-smokers who develop lung cancer are more likely to have cells with a fault in a gene called EGFR.
	3.1.1 Prévention - Tabac - e-cigs
She Couldn’t Quit Smoking. Then She Tried Juul. [NY Times] Millions embrace e-cigarettes as smoking cessation aids. Will restricting the devices for teenagers put former adult smokers who vape at risk to start again?
	4.2 Dép., diag. & prono. - Génome
These DNA Startups Want to Put Your Whole Genome on the Blockchain [Wired] Two different marketplaces for genetic data, Nebula and EncrypGen, recently launched with the promise of better protections for their users.
	5.1 Traitements - Pré-clinique
PI3K Inhibitors: You’re Doing It Wrong [In the Pipeline] Overall, it looks like the insulin receptor effect on tumor growth only really kicks in at quite high insulin levels. Which perversely is what the PI3K inhibitors are providing!
	5.10 Traitements - Essais
Standard chemo still most effective for throat cancers caused by HPV [Cancer Research UK] The study, published in The Lancet, found that patients taking either the standard chemotherapy drug cisplatin or another targeted cancer drug called cetuximab (Erbitux) experienced little difference in side effects. But survival was significantly better in those who received the standard of care drug cisplatin. Their cancers were also less likely to return.
Patients with HPV-positive throat cancer should keep taking chemotherapy [Institute of Cancer Research] The study found that in fact, people treated with cetuximab survived for a shorter time than those treated with cisplatin, and the occurrence of side-effects was similar in both treatment groups.
	5.12 Immunothérapies
New dual-action cancer-killing virus [MRC] “We hijacked the virus’s machinery so the T-cell engager would be made only in infected cancer cells and nowhere else in the body. The T-cell engager molecule is so powerful that it can activate immune cells inside the tumour, which are being supressed by the cancer, to attack the fibroblasts.”
	5.12.4 Immunothérapies - Essais
AstraZeneca’s Mystic OS analysis paints tremelimumab as a dud in NSCLC [FierceBiotech] Research is continuing, though. AstraZeneca thinks the OS data justify further analysis in exploratory subgroups, although the available evidence leaves little scope for optimism about tremelimumab.
MYSTIC deals another blow to AstraZeneca as Imfinzi misses on OS [BiopharmaDive] In MYSTIC, NSCLC patients with 25% or greater PD-L1 expression were given either Imfinzi, Imfinzi plus a CTLA-4 inhibitor called tremelimumab, or standard of care chemotherapy. Results published last summer showed the combination failed to significantly improve progression free survival, dampening hopes that it would succeed on the tougher co-primary endpoint of OS. Indeed, the pairing missed on that measure.
	5.12.6 Immunothérapies - AMM
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018 [EMA] The CHMP also adopted a positive opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer), after re-examining its negative opinion adopted in July 2018.
	5.12.8 Immunothérapies - Economie
Innovative skin cancer drug available on Cancer Drugs Fund [NICE] Patients with a type of advanced skin cancer have a new treatment option as pembrolizumab, also known as Keytruda, has been recommended for use on the Cancer Drugs Fund. This recommendation applies to adults who have melanoma that has spread to the lymph nodes, an important part of the body’s natural defence system.
	5.2 Pharma
Belgium’s Camel-IDS reels in €37M to push breast cancer radiotherapy [FierceBiotech] Its lead program, CAM-H2, is based on its technology that links radionuclides—radioactive atoms or nuclei—with single-domain antibodies derived from, you guessed it, the camel family.
With radiotherapy en vogue, Belgian startup nabs nearly $42M in Series A funding [EndPoints] In this class of drugs, the radioactive agent is taken up in the cancerous tumor and the radioactive toxins are specifically targeted to destroy the affected tissue, versus chemotherapy, which does not discriminate between mutated tissue and healthy cells.
	5.2.1 Pharma - Partenariats
After historic win, Lilly partner Chi-Med’s Elunate flops in lung cancer [FiercePharma] It was only two months ago that the drug made history as the first China-discovered medicine to be cleared for a major cancer type when China’s drug regulator green-lighted the product as a treatment for third-line colorectal cancer. Through a collaboration deal signed back in 2013, Lilly is now preparing for that launch in China.
	5.2.3 Pharma - économie
Pfizer preps a laundry list of drug price hikes for the New Year — let the political fireworks begin [EndPoints] Two years ago, that news would have been greeted as a sign of remarkable moderation. But for early 2019, after Trump has repeatedly excoriated the majors for “getting away with murder” on drug prices, it’s likely going to be seen as a call to legislative arms.
Pfizer to raise U.S. drug prices in January after previously backing down [Reuters] The company rolled back a set of price increases in July after Trump said in a tweet that the drugmaker “should be ashamed” and that his administration would respond. Pfizer said then that it would defer price increases until the end of the year or until the president’s drug pricing plan went into effect, whichever was sooner.
	5.3 Traitements - FDA, EMA, NICE...
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs [FDA] Recently, new tools for capturing data in the post-market period, including more sophisticated use of real world data and real-world evidence (RWE), are providing new approaches to address important questions about the safety and benefits of new drugs in real world settings. These approaches have the potential to do to so more rapidly and with greater efficiency than traditional methods.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab) In Patients With Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia [Amgen] Application Based on Data From the Phase 2 BLAST Study, the Largest Prospective Trial in Minimal Residual Disease-Positive Acute Lymphoblastic Leukemia.
Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer [Novartis] CHMP opinion is supported by two pivotal Phase III trials showing clinical benefit of Kisqali-based regimens, regardless of combination partner or menopausal status, as first or second-line treatment.
Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease [Janssen] Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years.
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot [FDA] This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
EMA Recommends Granting a Marketing Authorisation for Apalutamide [ESMO] On 15 November 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product apalutamide (Erleada), intended for the treatment of non-metastatic castration resistant prostate cancer.
	5.9.4 ENA
Agendia Breast Cancer Tests Show Promise for Improved Therapy Prediction [Genome Web] The Agendia investigators asked in their I-SPY 2 analysis whether HR-positive HER2-negative tumors classified as basal by BluePrint might be more responsive to targeted chemotherapy than those classified as the more typical, or more expected, luminal type.
	6.11 Patients
Tackling Cancer Anxiety [NY Times] No matter how long I deal with ovarian cancer, scanxiety threatens to assert its nasty vigor in advance of periodic blood tests and abdominal CTs.