Onco Actu du 21 janvier 2019

	2. ETIOLOGIE
FDA: Irbesartan lots recalled over likely carcinogen [UPI] Prinston Pharmaceutical, doing business as Solco Healthcare, has voluntarily recalled of eight more lots of irbesartan blood pressure medication after detecting trace amounts of impurity in an active pharmaceutical ingredient, the Food and Drug Administration announced Friday.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
FDA chief threatens to take e-cigarettes off the market [NBC] Experts agreed it won’t be easy to help addicted youth kick the vape habit.
	4.12 BIOPSIES LIQUIDES
How new tests might help find treatments for cancers with no known origin [Cancer Research UK] “In Manchester, we are profiling a lot of patients as part of one of our academic trials called TARGET,” Cook says. “We are taking blood tests from patients, analysing the DNA in the blood and looking at whether there are any molecular changes in that DNA related to the cancer. We can then see whether there is an existing drug we have access to that targets that molecular change.”
New combination blood test for pancreatic cancer may catch disease earlier [Van Andel Institute] The improved detection rate offered by the combined use of the sTRA and CA19-9 tests makes this approach a viable option for screening and early intervention, particularly in people who have a higher risk for developing the disease.
	4.7 DÉP., DIAG. & PRONO. - COL DE L'UTÉRUS
Smear tests: women asked to discuss fears as test rate plummets [The Guardian] Jo’s Cervical Cancer Trust surveyed more than 2,000 young women about their experiences. It found that of 915 women who had delayed a test or never gone for screening, 71% felt scared while 75% felt vulnerable. Eight out of 10 (81%) said they felt embarrassed, while 67% said they would not feel in control.
	5.10 TRAITEMENTS - ESSAIS
AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer [AbbVie] The RESOLVE (PCYC-1137) trial evaluated ibrutinib in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents. The study did not show statistically-significant progression-free or overall survival benefit with ibrutinib in combination versus the placebo combination study arm.
AbbVie's Imbruvica fails to meet main goal in pancreatic cancer study [Reuters] The treatment, Imbruvica, failed to show statistically significant improvement in progression-free survival (PFS) or overall survival in metastatic pancreatic cancer patients, compared with the combination of placebo and two chemotherapy agents.
	5.12.1 IMMUNOTHÉRAPIES - PARTENARIATS
Celgene strikes Obsidian deal to boost CAR-T options [Fierce Biotech] Obsidian thinks the immunomodulatory factors can enhance adoptive cell therapies but only if they are closely controlled. To achieve such control, Obsidian has designed small, fully human protein domains that facilitate regulation of the expression of transduced genes by small molecules.
Despite Buyout, Celgene Dealmaking Rolls On With Kyn, Obsidian Tie-Ups [Xconomy] Both deals come with some uncertainty: Kyn and Obsidian will now join the long line of biotechs wondering what the future might hold for their partnerships if the $74 billion mega-merger goes through.
Celgene inks first deals since Bristol-Myers announced $74B buyout — bets $80M on immunometabolism [EndPoints] The latest tie-up involves Kyn Therapeutics, a Boston startup backed by Atlas Venture and OrbiMed to go after metabolites that keep the immune system from attacking cancer.
	5.12.6 IMMUNOTHÉRAPIES - AMM
Canada Health approves Novartis' CAR-T therapy Kymriah [Pharmafile] While providing Kymriah for young patients with ALL is expected to cost just $25.6 million in the first three years; the panel believe it may cost as much as $387.4 million to cover adults with lymphoma due to the higher prevalence of the disease.
	5.2 PHARMA
On heels of Loxo buy, Lartruvo setback deals a blow to Lilly's oncology hopes [Fierce Pharma] Now, Lartruvo is in crisis mode. Lilly is “working with global regulators to determine the appropriate next steps” for the med and is taking a pre-tax charge of $70 million to $90 million this quarter. For the year, it expects a 17-cent hit to earnings per share from the trial failure.
Failed Clinical Trial Puts Eli Lilly Cancer Drug in Limbo [Xconomy] Olaratumab is an antibody drug developed to bind to a protein thought to play a role in tumor growth. The FDA approved olaratumab on an “accelerated” basis—that is, on a thinner body of evidence than is usually required—in 2016.
Lilly suspends Lartruvo promotion after Phase 3 failure [Biopharma Dive Lartruvo isn't the only drug to secure accelerated approval and later run into trouble in subsequent clinical study.
Lilly’s approved cancer drug Lartruvo fails confirmatory study, setting the stage for withdrawal of regulatory endorsement [EndPoints] Data from the previous, positive Phase II trial had helped Lilly secure accelerated approval in the United States, and conditional approval in Europe.
Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO® [Lilly] Study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population.
Lilly cancer drug fails key trial, will no longer be prescribed [Reuters] Lilly oncology chief Anne White said in a phone interview the results were “completely unexpected.”
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod [Reuters] The approval here comes just a few weeks after the health regulator gave Celltrion Inc's Herzuma - another biosimilar to Herceptin - its nod to market it commercially.
	5.5.5 ASCO (GASTRO-INTESTINAL)
Lilly Phase 3 REACH-2 Trial Data Published in The Lancet Oncology Shows Improvement in Overall Survival with CYRAMZA® (ramucirumab) in Second-Line AFP-High Hepatocellular Carcinoma Patients [Lilly] Pooled data analyses of AFP-High patients in the REACH-2 and REACH trials showed an improvement of 3.1 months in median overall survival.
Servier and Taiho Oncology Present Latest LONSURF® (trifluridine/tipiracil) Data at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) [Servier] The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in overall survival (OS) compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo).
	6. LUTTE CONTRE LES CANCERS
Dr. John Mendelsohn, 82, Researcher Who Led Top Cancer Center, Dies [NY Times] Dr. Mendelsohn began his career as a researcher. He made his name in the 1980s at the University of California, San Diego, where he developed cetuximab, the first so-called targeted cancer therapy, which blocks receptors on cancer cells to halt their growth.