Filled with blessings and making a virtual mess on my kitchen counter, my cup runneth over these days, so I am LONG overdue in sharing my incredible experience at the AACR (American Association for Cancer Research) Annual Meeting as a participant in the Scientist <->Survivor Program.
AACR: AN UPDATE
If you’ve been to AACR you will totally get this. If you’ve been to SABCS, you’ll come close to getting this. If you’ve never attended a medical conference as an advocate, you may not get this, but rest assured most of us conference junkies really don’t either.
The seemingly simple task of creating a conference schedule is a Herculean effort. The full AACR Program guide is – I kid you not – 724 pages. Sure, there’s an app for that, but mastering the categories in which the app sorts sessions is beyond my chemo-addled mind. All this to say, my primary goal was to collect as much information as I could about the latest advances in MBC and I’m sure there were sessions I never even found. In addition, my AACR’s Scientist <-> Survivor Program team was tasked with the responsibility with preparing a presentation on clinical trials. Plus Jody Schoger (of #BCSM fame) and I presented a poster on Breast Cancer Advocacy. The challenge: too few hours in a day! I had greater success on the clinical trials front than I did with MBC breaking news, but below you will find a hodgepodge of updates I hope you find helpful.
The most significant headline for MBC patients:
The drug formerly known as PD-0332991 (aka PD-991) and I first met at SABCS 2012, and it has now entered Phase III trials with continued positive results. Lifespans for MBC patients are measured in months, and patients are generally expected to live 24-30 months from the time of diagnosis. The hope has been that this drug given in combination with letrozole (PFS of 26.1 months vs. 7.5 months on letrozole alone), is a game changer. This could more than double the time to progression, having a critical impact on the life expectancy of MBC patients. Palbociclib is a CKD 4/6 inhibitor and letrozole is an aromatase inhibitor. The Phase III trials will look at palbociclib in combination with letrozole or fulvestrant in ER+/Her2-/postmenopausal women. Since AACR the drug has been given FDA Breakthrough Status, hopefully it will arrive soon to a clinic near you. Palbociclib is being developed by Pfizer.
OTHER CDK 4/6 INHIBITORS
In the same class of drugs are LEE011 (Novartis) and LY2835219 (Lilly), which both show promise as well. LEE011 is moving into Phase II trials for a variety of cancers. In MBC it is in Phase I/II in combination with a variety of aromatase inhibitors. LY2835219 is in Phase II with fulvestrant and in Phase I for other cancers. The latter is of special significance since it is being evaluated for patients with prior therapies, those patients who often have very few options.
There were other updates, continued good news about the success and possible expanded use of trastuzumab, focus on cancer stem cells, and one of my personal pet peeves – a continued lack of biomarkers so we know what drugs work best for which patients. All in all, not a ton of news that I could find. Which remains the frustration of MBC patients everywhere…
BUSINESS AS USUAL?
Our lives hang in the balance of research, which many feel is a painfully slow process. Experimental drugs typically go through a multi-phase clinical trial process after which, assuming they fare well, get in line for FDA approval. All in all, it can take a decade or more for some drugs to make it from the scientist’s bench through trials, to the FDA and onto the pharmacy. You would be hard pressed to find anyone in the research or advocate community who thinks the current trial/drug approval process is effective, efficient or good for patients. And while the pharmaceutical companies that sponsor much of the research are for-profit institutions, their financial investment is great. Between the cost of running trials, and the reality that not all trials bring a product to market, you can begin to see one cause of the extraordinary price of therapy – especially new ones.
So let’s just call the system “broken.” We can bemoan it, but can we change it? Some are trying. For those interested, read on about new models in research and clinical trials…
An “adaptive trial design,” I-SPY 2 seeks to more quickly evaluate the benefit of trial, constantly shifting the agents used in the trial. Drugs that work for a particular patient group are focused on them, while agents that don’t provide benefit are dropped from the trial. In order to best evaluate the impact of the therapies for trial participants, chemotherapy is given before surgery (neo-adjuvant). At the same time, the trial tracks markers that will allow more efficient targeting of drugs in the clinic. Patients are monitored throughout the treatment and once chemo is finished, they go on to other treatments such as surgery, radiation and/or endocrine therapies. The trial was developed in cooperation with a variety of researcher centers and pharmas as well as the NCI and FDA, in order to ensure to would be a collaborative effort and drugs could proceed to the approval process.
Stand Up To Cancer
A little less trial design and more research design is the Stand Up To Cancer effort. Founded in 2008, the laudable goal is to bring an end to cancer. Leveraging the efforts of the entertainment industry, the media and more, the goal is to fund “Dream Teams” and innovative, high-risk/high-reward research. They seek to eliminate barriers, foster collaboration and seek rapid progress, and with more than a hundred clinical trials and thousands and patients enrolled, let’s hope they’re on the right track!
Global Alliance for Genomics and Health
There’s a lot of health data out there. A LOT! And it’s stored all over the place, from individual Electronic Medical Records (EMRs) to clinical trial databases, to personal genomic testing such as BRCA tests. It’s everywhere and there is invaluable information to be mined. The challenge is that everyone has their own system and we don’t yet have a means to share de-identified data safely and efficiently. This is where Global Alliance comes in. Their mission is to bring together stakeholders from all parts of the system, and across the globe, to identify and address issues related to access to and the evaluation of this data. And when they achieve that there will be a goldmine of information that can be analyzed to the benefit of all of us.
AACR SCIENTIST <-> SURVIVOR PROGRAM
I was thrilled to participate in this program and if you’re interested in conferences, this is the way to go. I put my toes in the water with the wonderful program offered by the Alamo Breast Cancer Foundation at SABCS last year, and I found this to be a great progression! We had access to top scientists who support and partner with survivor advocates, faculty who were available to answer questions and make sense out of each day’s news, and the opportunity to delve more deeply into critical topics facing cancer research.
Personal highlight: A Night at the Lab with Peter Kuhn, PhD and his team. It was a GREAT opportunity to get up close and personal with a working lab, seeing how things operate and meeting the people who are changing the world. You can learn more about the program here.