This article was originally published on LinkedIn.
As I sat down to write this latest post, I was suddenly struck by how little I have written about breast cancer over the course of these articles. This came as quite a surprise given that breast cancer research has played an important, if not always welcome part in both my professional and personal life.
I’ve been lucky enough to be involved in breast cancer research throughout my career, and incredibly fortunate that it continues to be at a time of such monumental change in oncology. When I finished College, chemotherapy was standard of care for all cancer types, but soon after we started entering the era of personalized medicine with the arrival of Gleevec, followed by Herceptin.
Later, I had the opportunity to run the HER2 franchise at Genentech and see first-hand the impact of the three HER targeted treatments that were the result of 30 years of dedicated research.
These early approaches pioneered in breast cancer began an unstoppable avalanche of research, progress and change that spanned multiple decades and shaped the oncology landscape of today. It changed our whole approach to oncology, not just in treatment, but diagnostics and monitoring, ultimately paving the way for next generation molecular diagnostics and comprehensive genomic profiling (CGP). When I think about today’s environment, I truly believe that we are on the cusp of another monumental change, one that we have been building towards for a number of years.
BIG DATA HAS BIG POTENTIAL
Making personalized medicine the standard of care in the clinical setting relies on good data; diagnostic data, monitoring data, outcomes data. The more data that can be studied (from as many patients, tumor types, countries and settings as possible), the more we are able to learn about cancer biology and genomics. With consistent data, we can feed discovery through research and optimize treatment decisions via real-time insights in the clinic.
My passion for what we offer at Foundation Medicine stems from my belief that CGP can play a fundamental role of advancing personalized medicine, by amplifying the volume of data we feed into the precision medicine engine and improving the consistency, quality and potential of that data.
So, as we approach the San Antonio Breast Cancer Symposium, the leading breast cancer meeting of the year, I wanted to take some time to provide my perspectives on the latest milestone we have reached with one of our oncology partners, and its significance for patients living with advanced breast cancer and for personalized medicine as a whole.
ANOTHER STEP FORWARD FOR METASTATIC BREAST CANCER (MBC) PATIENTS
FoundationOne®CDx is now FDA approved as a companion diagnostic (CDx) for Novartis’ PIQRAY® (alpelisib), the first targeted treatment for patients living with HR+, HER2-, PIK3CA-mutated advanced breast cancer.
40% of HR+/HER2- patients have PIK3CA mutations and the availability of the first PIK3CA targeted treatment earlier this year was wonderful news for patients. The approval of FoundationOne CDx as a CDx for this targeted treatment means that patients with PIK3CA mutations can be identified through a comprehensive and validated approach. This allows the physician to determine the right treatment roadmap for each patient based on their individual mutations – a roadmap that may include approved targeted treatments, like PIQRAY, or clinical trial options.
But why do I feel this approval has a wider significance for personalized medicine as a whole? To me, a comprehensive approach to genomic testing maximizes its potential. The evidence to support this is overwhelming – genomic drivers of cancer do not operate in isolation; the cross-talk, interplay and feedback loops between oncogenic pathways is huge, and that is why cancer is such a formidable enemy.
Teresa McKeown’s personal story encapsulates the importance of a comprehensive approach to genomic testing. Teresa was diagnosed with advanced breast cancer in 2016 and quickly ran out of options when her cancer didn’t respond to treatment. By chance, she took part in the I-PREDICT trial exploring the utility of CGP, and her results suggested a non-standard treatment approach that would not have been considered otherwise (and indeed, was not funded by her insurers). She managed to secure the medicine under a compassionate use program, her tumor markers rapidly improved, and two years later, she is living her life and helping to support other patients through awareness and education. Teresa’s story powerfully reinforces our motivation to continue to collaborate with our partners across the oncology landscape to improve the uptake of CGP.*
We are at a tipping point in the treatment of MBC and CGP is increasingly being utilized in this tumor type. This PIQRAY companion diagnostic approval marks a key advancement in personalized breast cancer treatment, taking us one step closer to helping more patients benefit from personalized medicine. My hope is that one day we will have multiple personalized treatment options for every MBC patient. With more than 120 biomarker-led, industry sponsored trials currently active in advanced breast cancer, I am optimistic about the future.
A VERY PERSONAL HISTORY
I wanted to finish by reflecting on my personal shared history with breast cancer. Both my mother and my aunt survived breast cancer although my aunt tragically passed away later due to colorectal cancer. Back in 2002 when my mother was first diagnosed, the options available to her were very limited. We just didn’t have the knowledge around multiple molecular drivers or the ability to test at a molecular level to inform treatment decisions.
When I think back to what my mother and my aunt went through, the resounding memory is one of seeing the people you love in pain and full of fear, with the constant stress of waiting for results or the worry that the treatment would stop working. It was an incredibly difficult time for both of them, both physically and emotionally, as well as for our family. A cancer diagnosis rocks your family to the core, regardless of your background, role or how much knowledge you have in the area.
Today the treatment landscape looks vastly different. There are many more treatment options and directions available for people living with advanced breast cancer today, many of which offer fewer side effects and a vastly improved quality of life. That doesn’t mean that a cancer diagnosis today is any easier, and I’m certain that for any family who is reeling from a similar diagnosis right now, the impact is just as keenly felt.
But today, many cancer diagnoses come with more options, better outcomes and more hope. This, above all else, is why we need to continue to fuel innovation and lay the groundwork for the advancements in personalized medicine that are yet to come - for all people like Teresa, and my mother and my aunt. With that in mind, I hope you all have a very fruitful time at San Antonio.
* Personalized Precision Cancer Therapy Offers New Hope. October 2019. Teresa Mckeown. Cure Today. Teresa’s experience with genomic testing is unique to her and treatment outcomes will vary based on your cancer type and unique genomic profile. https://www.curetoday.com/share-your-story/personalized-precision-cancer-therapy-offers-new-hope.
FoundationOne CDx is a test intended to help doctors identify which cancer patients may benefit from certain treatments or clinical trial options. Use of the test does not guarantee that you will be matched to a treatment or clinical trial, or that all relevant alterations will be detected. Some patients may require a biopsy, which could pose a risk. For the full labeling, including indications for use and safety information, visit our website at www.startwithstepone.com.