Personalized Healthcare: What It Means and Why It Matters

When it comes to cancer treatment, one size does not fit all. Of the estimated 1.6 million Americans who will be diagnosed with cancer in 2016, no two will be exactly the same. More and more, we’re hearing (and using) buzzwords to this effect: Personalized healthcare. Precision medicine. Targeted therapy.

Transforming the way we use medicine

At AstraZeneca, personalized healthcare is about helping physicians identify patients who may be eligible for appropriate treatment options. We start with an intricate understanding of the biology of the disease, then use that knowledge to identify biomarkers: biological molecules found in body fluids or tissues that provide insight into the state of the disease, such as gene mutations or protein expressions. Finally, we leverage biomarker tests, known as companion diagnostics, which doctors can use to inform treatment decisions for individual patients.

While so-called “personalized medicines” have existed for more than a decade, advances in science and technology have made diagnostics smarter, more targeted, and more accessible. We’re excited that AstraZeneca is consistently at the forefront of this science, analyzing gene mutations and protein expression, developing targeted therapies, and working with leading diagnostic partners to develop tests.

Ultimately, personalized healthcare is about more than medicine: it is a philosophy that guides our approach to research, delivery, and everything in between as we work to improve the lives of patients whom we serve.

Biomarkers in cancer

In the field of oncology, the impact of personalized healthcare is particularly evident: targeted treatments are helping cancer patients live longer, healthier and more productive lives. Since its peak in 1991, the cancer death rate is down about 20 percent and the five-year relative survival rate has climbed to about 68 percent.

One of the most landscape-altering advances in the last decade has been the discovery that tumors are driven by individual genes. Each individual’s cancer has a unique set of genetic information and every tumor has its own set of mutations and genetic alterations. The ability to identify which genes are important and target them directly has enabled us to develop new medicines and tailor their use for the right patients.

Importantly, while this understanding has already led to critical advances, our research is ongoing to ensure that as many cancer patients as possible can benefit from personalized approaches.

For example, tissue biopsies have become the gold standard for determining the presence of the epidermal growth factor receptor (EGFR) mutation in non-small cell lung cancer (NSCLC) patients. The presence of EGFR in a tumor suggests that these patients are more likely to respond to drugs that inhibit the EGFR pathway. There are times, however, when obtaining a tissue sample presents challenges –  such as when the tumor is difficult to locate due to its size or location, or when tissue heterogeneity results in different molecular biomarker expression in different parts of a sample. For certain patients with metastatic EGFR mutation-positive NSCLC, who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine, AstraZeneca has collaborated to develop a blood-based test that has the potential to detect a specific mutation (T790M) in the tumor’s deoxyribonucleic acid (DNA) that may be circulating in the bloodstream. Put simply, blood-based testing may offer a convenient, less-invasive option to identify the biomarker (eg, EGFR) of a patient’s tumor, which may inform treatment decisions.

Other notable cancer biomarkers informing clinical decisions in various tumors today include but are not limited to:

  • ER (breast cancer)
  • HER2 (breast cancer)
  • c-KIT (gastrointestinal cancer)
  • ALK (lung cancer)
  • BRAF (melanoma)
  • KRAS (colorectal cancer)
  • BRCA 1 & 2 (breast and ovarian cancers)
  • EGFR T790M (for certain patients with EGFR mutation-positive metastatic non-small cell lung cancer, who have progressed on or after an EGFR TKI medicine)
  • PD-L1 expression (biomarker for immuno-oncology therapies in various tumor types)

There are many more biomarkers still to be discovered and explored that could potentially lead to new targeted therapies.  

Additionally, despite the wealth of evidence that biomarker testing is helping to advance progress in cancer treatment as one of several factors that influence therapy selection, many patients are still not being tested for biomarkers that could identify them as candidates for targeted treatment options. We are committed to changing this by raising awareness and broadening scientific exchange around testing to improve patient outcomes.

Over time, personalized approaches to cancer care have the potential to improve the overall survival rate across a broad range of tumor types, giving us the opportunity to change outcomes for patients on a meaningful scale.

A personalized pipeline

Every day, our teams are motivated by one simple question: how can we make devastating diseases like cancer less devastating? More often than not, our answer is this: we are committed to continuing research that focuses on tailoring treatment options to address serious unmet needs in the right patients at the right time.  

To get there, we’re ensuring that our robust pipeline of investigational therapies is focused on the future. In fact, more than 80 percent of our pipeline across all AstraZeneca therapeutic areas is being developed with a personalized healthcare strategy and more than 20 research programs have a companion diagnostic test. Our personalized healthcare team works to identify biomarkers early on in the drug development process, as this has been shown to actually shorten the time needed to bring new medicines to patients.

That said, no one company has all the ideas – partnership and collaboration are essential aspects of innovation. We are pairing our highly skilled drug development teams with diagnostic partners, working with physicians at respected institutions, and collaborating with regulatory authorities to help shape the treatment pathways for personalized healthcare and support smart clinical trial design.

Working together – with researchers, regulators, payers, healthcare providers, policymakers and key stakeholders – we can deliver more personalized treatments on a patient-by-patient basis that will ultimately improve care for individuals, families and society as whole.

 

3302105 Last Updated 11/16