Phesi, a provider of AI-powered clinical development analytics, has delved into data from 2.5m breast cancer clinical trial patient participants around the world. Since 2014, the findings indicate, the number of women younger than 60 taking part in such studies has increased dramatically, from 30% to about 90%. As previous Phesi analysis has shown, breast cancer ranks among the most extensively studied diseases globally, topping that list in 2021.
To learn more about the recent analysis and how it might inform future breast cancer studies, Outsourcing-Pharma checked in with Gen Li, Phesi CEO and founder.
OSP: Could you please share some of the reasons Phesi decided to tackle this analysis?
GL: Breast cancer affects 2.2m people a year globally and is the second most common cancer in women in the US. An earlier analysis of global trials that we conducted showed that breast cancer was the most studied disease area globally in 2021. Given these numbers, we decided to take a closer look at clinical trials and breast cancer given its importance to both patients and to the clinical development sector.
OSP: Please share whatever expectations you might have had about the findings before you deployed the analysis.
GL: Our goal is to conduct analyses that are completely objective and to avoid having too many expectations because that is how we work with our customers. We strive to be data-led and to give an unbiased analysis that enables better decision-making.
That said, our experience has taught us that whenever we take a deep dive into a particular area, there is always lots to learn. In analyzing 2,511,046 breast cancer patients from 4,674 total cohorts, we set out to better understand how the patient profile might be changing. Given that breast cancer is the most studied disease area globally, any insights will help to improve breast cancer clinical trial design and execution to ensure patients get the treatments they need faster.
OSP: Were there any surprises or otherwise notable numbers you would like to point out?
GL: The most notable figure is that the number of women under 60 participating in breast cancer trials has increased dramatically since 2014, with an overall increase in trial participants younger than 60 years of age rising from 30% around 20 years ago to 90%. That’s a significant finding.
Data from biomarker analyses also revealed some interesting results. We looked at patients with estrogen receptor (ER) positive biomarkers; there appears to be a decrease in ER-positive diagnosed cases from 45% in 2011 to 26% from 2014.
However, the takeaway here is that the number of ER-positive patients hasn’t decreased, but our understanding of different biomarker subtypes has become more sophisticated. For instance, increasingly comprehensive biomarker analysis has led to an increasing proportion of patients diagnosed with Triple Negative Breast Cancer participating in breast cancer clinical trials (subtype: ER- PgR- HER2- TNBC).
OSP: As you mention, women younger than 60 now make up about 90% of BC trial participants, compared to about 30% just eight years ago. Can you please share any insight you might have about why that might be, and what it indicates about the current or future state of BC research?
GL: One of the biggest reasons for the increase is the success of public health campaigns that raise awareness of the disease and encourage patients to spot signs earlier. Additionally, many developed nations have robust programs to increase screening – including of younger women – by mammogram.
As earlier diagnosis of breast cancer is becoming more common, there is now greater opportunity to develop treatments that target more aggressive forms of the disease early on, as they are identified sooner and offer a bigger window for intervention.
OSP: Specifically, how might having younger women affect trial design and other study considerations?
GL: Clearly one of the biggest challenges will be around potential fertility and pregnancy issues. These concerns that were less of a priority before will now need to be considered to get patients to commit to trialing new treatments.
There will also be differences in a younger cohort to consider for trial design, including comorbidities and medication history. Sponsors must now take advantage of existing patient and trial data to improve enrollment of patients that match protocols. Moreover, breast cancer trials must be dynamically designed around the complexities of this patient profile and be able to adjust in real-time.
OSP: Also, what might these results indicate about precision cancer medicine?
GL: Overall, the analysis shows that a greater understanding of breast cancer is advancing the industry towards developing tailored treatments. The progress made in recent years in genomics and sequencing has given sponsors access to a greater volume of data on biomarkers and disease characteristics. Whilst this has increased complexity it also offers more opportunities to create precision therapies and treatment regimens.
The vast amount of patient data available also increases the likelihood of identifying multiple cohorts of patients matching a specific clinical trial design. This makes it possible to deploy digital twins and synthetic control arms.
What’s really key is that patient-centricity remains the focus. There will inevitably be heavy competition for patients, especially as we learn more about the molecular pathology of their cancer, so it’s important that sponsors put patients at the heart of trials. Existing data will optimize clinical development and accelerate the path to precision cancer medicine while putting patients’ needs first.
