Onco Actu du 8 août 2019

  BIOLOGIE  

NIH researchers uncover role of repetitive DNA and protein sequences in tumor evolution [NIH] 
“This study shows that repetitive sequences, which are ‘hotspots’ of DNA evolution, emerge early in tumor evolution but fade away in later phases, particularly during the transition to metastatic states, though they leave clear marks in the genome.”

  DÉP., DIAG. & PRONO. - PANCRÉAS  

Still No Call for Widespread Screening for Pancreatic Cancer, but USPSTF Says Yes for Those With Known Risk [AJMC] 
It’s an important shift for the diagnosis of a cancer that, while still relatively rare, is becoming a leading cause of cancer death in the United States as survival rates improve for other types.

  DÉP., DIAG. & PRONO. - INDUSTRIELS  

Myriad Will Seek FDA Approval of BRACAnalysis CDx® As a Companion Diagnostic for Lynparza® (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer [Myriad] 
The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.

  DÉP., DIAG. & PRONO. - GÉNOME  

23andMe had devastating news about my health. I wish it hadn’t come by email [STAT] 
That click changed my life forever: To my utter shock, the results showed that I have a mutation in a gene called BRCA1, which puts me at a huge risk of developing breast and ovarian cancer. I broke into tears.

  BIOPSIES LIQUIDES  

Investors keep the faith in cancer liquid biopsies [Nature Biotechnology] 
Despite slow uptake in the clinic, liquid biopsy tests incorporating methylation and other signatures are showing increasingly compelling data for non-invasive detection of cancer.

Highly sensitive blood test could improve breast cancer treatment [Cancer Research UK] 
In this first validation study, the researchers analysed 80 blood samples from 33 women with early stage and locally advanced breast cancer. They found that the test was able to identify circulating tumour DNA in every patient before they started treatment.

New ‘liquid biopsy’ blood test improves breast cancer diagnostics [TGEN] 
TARDIS is a “liquid biopsy” that specifically identifies and quantifies small fragments of cancer DNA circulating in the patient’s bloodstream, known as circulating tumor DNA (ctDNA). According to the study, TARDIS detected ctDNA in as low as 2 parts per 100,000 in patient blood.

Enhanced Glow: Direct detection of circulating tumor cells in blood samples [Wiley] 
In the journal Angewandte Chemie, scientists have now introduced an ultrasensitive method for the direct detection of circulating tumor cells in blood samples. It is based on the amplified, time-resolved fluorescence measurement of luminescent lanthanide ions released from nanoparticles that bind specifically to tumor cells.

  IMMUNOTHÉRAPIES  
 
T Cell Response to Immune Checkpoint Blockade Characterised [ESMO] 
T cell clones that may have just recently entered the tumour may be a cause for T cell response to immune checkpoint inhibitors.

  IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES,...  

CMS Says It Will Cover CAR T for Medicare Beneficiaries Nationwide [AJMC] 
CMS decided not to proceed with a model called Coverage With Evidence With Development (CED), which critics feared could overburden providers, causing some to opt out of offering CAR T-cell treatment to Medicare patients.

Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers [CMS] 
This policy continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

Medicare to cover expensive cancer cell therapies [Reuters] 
The decision follows the agency’s finalization last week of a proposal to raise its maximum CAR-T payment to 65% of estimated costs from 50%. Some hospitals will also be eligible for supplemental payments in certain cases.

CMS finalizes long-sought rules for Medicare CAR-T coverage [STAT] 
The policy is likely a positive development for hospitals, which have groused that lack of clear rules from the Centers for Medicare and Medicaid Services, combined with these treatments’ sky-high price tags, has hindered uptake.

  IMMUNOTHÉRAPIES - VACCINS  

Moderna chugs along, moving a second program into phase 2 [Fierce Biotech] 
The phase 2 study will pit a combination of mRNA-4157 and Merck’s PD-1 drug Keytruda against Keytruda alone in patients at high risk of melanoma recurring after their tumor has been surgically removed. It will enroll 150 patients.

  IMMUNOTHÉRAPIES - ÉCONOMIE  

New lung cancer treatment option approved by NICE [NICE] 
Immunotherapy drug pembrolizumab (also known as Keytruda) used with chemotherapy drugs carboplatin and paclitaxel will now be an option for adults with squamous non-small-cell lung cancer (NSCLC) which has spread to other parts of the body and who haven’t had any previous treatments.

  PHARMA  
 
AstraZeneca, Merck herald PhIII prostate cancer win for Lynparza — overtaking Clovis, J&J in PARP race [EndPoints] 
In their analysis investigators zeroed in on BRCA1/2 — a key qualifier for previous wins in ovarian, breast and pancreatic cancers — and ATM gene mutations. The effects of Lynparza, which blocks a self-repair mechanism adopted by cancer cells, on the other patient subgroups remain unclear.

Merck and AZ pile on more positive Lynparza data in bid to break into prostate cancer [Fierce Pharma] 
It’s the latest twist in what has become a mad race to the finish line for PARP inhibitors in prostate cancer.

Positive clinical trial results for olaparib in advanced prostate cancer [Institute of Cancer Research] 
“We’re now eagerly awaiting the final analysis of the trial. If the results look as good as these initial data suggest, men with advanced prostate cancer who have BRCA mutations should be able to benefit from olaparib – a tablet which doesn’t have the side effects of chemotherapy – in the next couple of years.”

  PHARMA - FUSIONS ET ACQUISITIONS  

Lilly shuffles executives overseeing oncology and M&A [Biopharma Dive] 
Bilenker's interim elevation to head up oncology research and early phase development was prompted by Levi Garrway, currently in the role, leaving his job to pursue other opportunities. Bilenker's duties will come in addition to his job as CEO of Loxo, now a wholly owned subsidiary.

  PHARMA - PARTENARIATS  

Cancer Research UK and Hummingbird Bioscience join forces to advance novel antibody drug into clinical trials [Cancer Research UK] 
HMBD-001 is the only anti-HER3 antibody in development that binds to the most critical region involved in HER3 activation, turning off this signal completely.
 
  LUTTE CONTRE LES CANCERS  

Pediatric Cancer Researchers, Clinicians Look to Enhance Molecular Data Collection, Distribution [Genome Web] 
In order to begin developing a model of data federation that's more in-line with what's been created for adult cancer databases, the NCI last week convened a meeting of stakeholders from academia, government, industry, and advocacy organizations for the Childhood Cancer Data Initiative (CCDI) Symposium, to discuss the challenges unique to pediatric cancer data and how to solve them.

  LUTTE CONTRE LES CANCERS - OBSERVATION  

Cancer statistics for adults aged 85 years and older, 2019 [CA: A Cancer Journal for Clinicians] 
We note differences in trends for some cancers in the oldest age group (eg, lung cancer and melanoma) compared with adults aged 65 to 84 years, which reflect elevated risks in the oldest generations. In addition, cancers in the oldest old are often more advanced at diagnosis.

Cancer screening rates ‘unexpectedly high’ among adults aged 85 years and older [Healio] 
Despite the limited likely benefit, many of the oldest old underwent some form of cancer screening, according to data from the National Health Interview Survey.

Cancer in the Oldest Old: The Fastest Growing Age Group in the U.S. [ACS] 
New report finds high rates of screening; less surgical treatment; and poorer cancer survival.

  LUTTE CONTRE LES CANCERS - ETHIQUE  

An Awful Idea: Paying to Get Into a Clinical Trial [In The Pipeline] 
No, no one needs this. It’s bad news in every direction. The FDA has the authority to do something about this, and they’d better.
 
Pay-to-play clinical trials: The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) weighs in [Respectful Insolence] 
I have a very hard time envisioning a situation in which clinical trial that requires patients to pay can be ethical. Maybe there is such a situation, but I need to be convinced.