GSK: Billions in, billions out

British pharmaceutical giant GSK had a pretty crazy news day on Monday, announcing two massive deals. First, the money going out: GSK will acquire the oncology biopharma company Tesaro for $5.1B. This deal adds Tesaro’s Zejula to the GSK portfolio, which will give it a foothold to fight AstraZeneca, Merck and Clovis Oncology in the PARP inhibitor market. That probably gives Clovis a big ol’ target on its back saying “Acquire me!” GSK should have enough cash to cover the deal after its other big Monday announcement where the company announced it will be divesting its healthcare nutrition business to Unilever for a cool $4B. GSK and its nutrition products had a good run, but sounds like someone didn’t drink their Horlicks and their relationship got tired.

Brother, can you spare a dime

Turns out pharma companies can spare a dime (or more) for cancer patients who want to participate in clinical trials. Pennsylvania recently became the 2nd state (after California) to sign a bill that “provides for reimbursement of patient expenses associated with participation in cancer clinical trials.” Wait, we need a bill for that? Guess so. The participation rate for people with cancer in the US is really low, like 3% low. Maybe these bills will create some positive momentum for clinical trial participation. Just a 1% increase in participation rates would be huge, given there are over 1,000 assets in the development pipeline targeting cancer. Apparently FDA came out with some guidance that reads “paying research subjects in exchange for their participation is a common and, in general, acceptable practice.” Good to know.

Cell phone cancer

I didn’t mean to imply cancer of the cell phone. My bad. According to NBC News, the US government’s National Toxicology Program released its report on the effects of cell phone-like radiation on tumor development. According to one rat participant “it’s not a tumor” (but really it was). Exposure to radiation of the types from 2G and 3G phones led to “cancerous heart tumors” in male mice. “…the totality of the available scientific evidence continues to not support adverse health effects in humans caused by exposures at or under the current radiofrequency energy exposure limits,” said a very dull-sounding Dr. Jeffrey Shuren from the FDA. Ok, but what about that heart tumor thingy? If that’s not confusing enough, the irradiated male rats also lived longer than the non-radiated rats. Must be a Spider Man thing. These results were about as clear as the reception from Straight Talk mobile service. Here’s a list of the best and worst mobile carriers in the US. Spoiler…Straight Talk suuuuuuuuks.

SSU, SIV, FPI and KPIs – oh my

It isn’t often you find real data in conference presentations, but we did. Clinical trials get delayed, no news there. A 2017 report from CenterWatch showed each additional month in a phase III trial added a median expense of $671,000. There are lots of “fixes” out there, but if you’re involved in oncology trials, you’ll find an insightful site start-up presentation from Alicia Williams, Senior Project Manager at MedSource here. InsightCity reached out and asked her “What’s the one thing people should know?” Her response, “The key to improving site start-up time and efficiency lies in proper planning, information sharing, and transparency. Working collaboratively with our sponsors and sites and putting in the preparation to drive timelines leads to success.  It’s not easy, but it has a proven track record.”  Well said and thanks for not creating another conference presentation that looks like this.

Not playing by your own rules

The well-known oncology researcher José Baselga has resigned his position as Chief Medical Officer at Memorial Sloan Kettering after an NYT/ProPublica investigation showed he failed to disclose millions in payments from pharma and healthcare companies in dozens of his research articles. The payments themselves aren’t at issue, it’s the fact that he didn’t make his ties explicitly known. Which is kinda funny since those financial reporting rules were set by the American Association for Cancer Research while he was president of the group. Critics say Baselga’s fall illustrates the bigger problem of the revolving door between academic research and industry, as well as a general laziness towards enforcing ethical standards from the academic community. Expect a rush of researchers who ‘forgot’ to include their financial ties in previous papers to quietly go add those in.

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.

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!