And the winner is…

All of us. Thanks to James Allison and Tasuku Honjo, winners of the 2018 Nobel Prize in Medicine, we now have a much better understanding of cancer, and how to treat it. Allison and Honjo characterized two very important and potent pathways – called “immune checkpoints” – that can shut down the immune response (CTLA-4 and PD-1). Anyone heard of “monoclonal antibodies?” Of course you have, and well, that’s thanks to these two smart people. For a really good article on their discovery and what it has led to go here. Dr. Allison is currently working at MD Anderson and you can see a short video of him here. MD Anderson has a very nice 3-minute video on “What is immunotherapy” that is worth a watch. Everyone together now, say “thanks guys”

The verdict is in (until the next study)

“…results show that the safest level of drinking is none,” reported a team of researchers in a recent study, funded by the Gates Foundation and published in the Lancet Medical Journal. The meta-analysis of more than 1,000 studies found alcohol to be responsible for nearly 3 million deaths per year globally. These deaths include—among other things—heart disease, cancer, and accidents. While studies that demonstrate the beneficial effects of alcohol receive much popular media attention, Robyn Burton of King’s College London believes, “the conclusions of the study are clear and unambiguous: alcohol is a colossal global health issue.” According to the study, in 2016, alcohol consumption was the single largest risk factor for early death in people ages 15 to 49. Party on, Wayne. Party on, Garth. And other Wayne’s World quotes. [Warning: semi-mature, stupid, adolescent humor]

Real-Time Oncology Review

Earlier this week, FDA granted its first approval as a part of two new pilot programs that aim to make the development and review of cancer drugs more efficient. The drug is Novartis’ Kisqali and the two programs are the Real-Time Oncology Review (allows for the FDA to review much of the data earlier, after the clinical trial results become available and the database is locked) and the Assessment Aid Pilot Project (used by sponsors to organize their submission into a structured format to facilitate FDA’s review of the application). FDA Commissioner Gottlieb says, “With today’s approval, FDA used these approaches to allow the review team to start analyzing data before the submission of the application and help guide sponsor’s analysis of the top-line data.” Looking for a heavyweight fight? Watch sales of Pfizer Ibrance vs. Novartis Kisqali.

We want you

DYK that ~86% of clinical trials don’t reach recruitment targets within their specified time periods? Did ya? And, DYK that fewer than 5% of adult cancer patients enroll in cancer clinical trials? If you’re in the clinical development space, this is not news to you and we’re here to tell you that CISCRP is trying to do something about it. Not to be confused with Cocoa Krispies, CISCRP is a non-profit organization founded in 2003 and dedicated to educating the public and patients and to engaging these critical stakeholders as partners in the clinical research process. As part of their marching orders, they have developed a “Medical Heroes Campaign” to re-brand how the public thinks about clinical research and those who volunteer for clinical trials. To see the June supplement in USA Today go here. Remember, no clinical trial volunteers, no new medicines. Mic drop.

Cancer caused by CRISPR?

Two studies released this week looked at the tumor-suppressing gene p53 and found that it doesn’t play nicely with CRISPR-Cas9. P53 is responsible for scrambling emergency services when DNA is damaged, which CRISPR-Cas9 does when cutting into DNA strands and adding some new DNA. The emergency response is a take-no-prisoners approach which either ‘fixes’ the DNA, rendering the gene therapy useless, or kills the cell. Astute readers may notice this also makes the therapy useless. That could answer why gene editing can be inefficient, and that’s also where the cancer risk comes in. The only cells that survive this process have faulty p53 genes, thus compromising the cells’ ability to fight future tumors. This was only observed with the DNA insertion process, so don’t sound the death knell for CRISPR just yet.

Cancer spending up. Duh.

According to a new report by the IQVIA Institute for Human Data Science, spending on cancer therapies has doubled over the past 5 years. And the retail price tag on these drugs is up, too. The average retail price of the 2017 launches was over $150,000, compared to $79,000 for those launched in 2013. You know, when they were practically garage sale prices. But before we get our knickers in a twist, IQVIA reports the average annual out-of-pocket spend for someone with commercial health insurance was just $500. With 1.7 million cancer diagnoses and over 600,000 deaths in the US alone forecast for 2018, that doesn’t seem like such a bad deal.

You’re my boy blue

This week, researchers from MD Anderson reported “significant durable disease control seen in patients with lung and thyroid cancers harboring the RET oncogene.” This is great news for people with the RET alteration. RET is linked to half of all medullary thyroid cancers, 20% of papillary thyroid cancers and 1-2% of non-small cell lung cancers. The phase I study of the compound BLU-667 from Blueprint Medicines is being conducted with 84 patients. According to lead investigator Vivek Subbiah “the data show the precision targeted therapy with next-generation kinase inhibitors can have a powerful impact for patients with RET-driven cancers.” All this seems great, unless you own Blueprint stock, which dropped 9% on the news. Wall Street. Anyway, here’s hoping the drug will show continued durability and effectiveness. You’re my boy blue!

This week, coffee bad

Every week it seems science determines coffee is alternately a health benefit and a health detriment. Well, a California judge has declared it settled. If the ruling stands, all California coffee sellers will be forced to place a cancer warning at the point of purchase. Plaintiffs in the case claimed—and apparently demonstrated—that the chemical acrylamide, produced as beans are roasted, increases the risk of cancer. Defendants lead by the likes of Starbucks claimed—and apparently failed to demonstrate—that the levels of acrylamide are not harmful, that coffee has health benefits that outweigh any potential harm, and that they can’t remove the chemical without altering the flavor. Like Shania Twain, the judge said, that don’t impress me much. The good news? If the ruling is upheld, coffee will still only cause cancer in California. Coffee-Cat meme.