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!

Trade wars don’t include cancer drugs

US stock markets have been roiling over a possible trade war between the world’s largest economies, the US and China. American President Donald Trump proposed nearly $50B in tariffs on Chinese goods, leading Chinese leaders to propose some of their own, but one product they’re not interested in taxing is foreign cancer drugs. China does have the world’s largest population of cancer patients after all. Drugmakers like Roche, Novartis and AZ should be pretty happy with the zero-tariff arrangement, while Chinese leadership hopes the move will push local pharma to improve their technological capabilities. Why can’t we go back to the good ol’ days when both the Chinese and Americans could ask “War, HUH, yeah, what is it good for?”

4. And this is why you go to school

AbbVie is now in a 5-year relationship with Johns Hopkins and Northwestern University. The goal?  Advancing oncology R&D. The pharmaceutical giant will work with each university independently, providing funding for preclinical research and access to AbbVie’s existing research. Of course, in the spirit of reciprocation, AbbVie can exclusively claim any new discoveries as its own. Therapeutic areas of research will include breast, lung, prostate, and colorectal cancers, among others. This is not the first time AbbVie has tapped the power of academic institutions. They entered a multi-million dollar oncology research collaboration with University of Chicago last April.  Arrangements like these have the potential to be a win-win-win for pharma, academia and patients alike. After all, sharing is caring.

4. A 21st century gold rush

The alchemists might have been aiming for something beyond wealth in attempting to turn base metals into gold. Recent research into the precious metal could lead to a new type of treatment for two of the deadliest cancers—i.e., pancreatic and ovarian—based on gold nanoparticles. Scientists already knew gold nanoparticles could be used to carry chemo drug molecules to tumors and to boost the effect of radiation on tumors, but new research shows that the gold nanoparticles interrupt cellular communication in the areas surrounding the pancreatic tumor. By butting in on the cell convo, the particles reduced cell proliferation and migration that usually occurs near these tumors. Added bonus—gold nanoparticles are not toxic to normal cells.