CLIMATE - Marking time

While there have been huge improvements in the treatment of cancer in the past decade, for some cancers the therapies still fall short in their efficacy.

Despite an estimated $307 billion due to be invested into cancer drug development globally by 2026 as pharmaceutical and biotech companies strive to develop the most effective treatments, certain cancers continue to have low survivability rates.

Meanwhile, for patients the side effects of life-prolonging treatments can be severe.

Taking lung cancer as an example, while the five-year survival rate for the condition has more than doubled since 2005, it remains a very difficult cancer to detect and treat, with only 10% of people surviving ten years following diagnosis.

In 2024, an estimated 234,580 new cases of lung cancer will be diagnosed in the US and 125,070 people will die from the disease.

The clinical need for improvements in the treatment of lung cancer is clear. When consulted, our pharmaceutical and biotechnology clients confirmed that having access to more in-depth and accurate information on lung cancer biomarkers and assays would be valuable.

We all want to move towards more ‘personalised’ cancer treatments to provide better outcomes for individual patients and more cost-effective therapies for healthcare providers. It is in no one’s interest to spend billions on developing drugs with low efficacy rates or harsh side effects.

A greater understanding of the biomarkers and assays landscape for specific cancers and aligning targeted treatments to an individual’s specific biomarkers to create ‘personalised treatments’ will be the next significant step forward in the treatment of cancer.

Data is key here, and we are only just beginning to scratch the surface in understanding the range of available biomarkers and assays, and their potential.

Biomarkers are an increasingly vital tool for providing cancer patients with the most effective and cost-efficient therapies.

Lung cancer has emerged as one of the fastest-growing oncology biomarker markets and given the urgent need to utilise biomarkers to develop novel treatments, Beacon has researched the global lung cancer biomarkers and assays clinical trial landscape.

It is our first standalone database since 2014. Our aim is to provide comprehensive data on research in this area so that our pharmaceutical and biotechnology clients can use this information in their drug development programmes.

Our research has collated publicly available information from over 6,100 existing trials and preclinical data and found information on over 2,300 established biomarkers and over 480 assays, just relating to lung cancer!

Significantly, our data shows that there are a far greater number of lung cancer biomarkers and assays than previously thought.

This increase has huge potential for the future treatment of lung cancer as it broadens the range of information available on biomarkers and assays for pharmaceutical and biotech companies to study and use as the basis for the development of new lung cancer treatments.

Further, it will help scientists to design clinical trials where drugs are effectively targeted to the patient, resulting in less toxicity and increasing the chances of the treatment’s success.

But it is the quality of the data that is important. There is a plethora of data but it needs to be collated and condensed to achieve actionable outcomes for drug development scientists. AI is driving innovation, and it can play a vital part in collating global clinical and preclinical data, but it is essential that this information is curated by human experts so that it can be reviewed, ensuring the most valuable and accurate information is available quickly and within a usable format.

Sharing accurate and relevant data and knowing the outcomes of previous clinical trials enable scientists to learn from others and implement that knowledge in their own trials. This will enable them to make faster, better drug development decisions.
We are already seeing the positive outcomes of this in terms of the number of preclinical trials for lung cancer using biomarkers.

Between 2013 and 2021 there has been an 11% compound annual growth rate in the number of trials starting, and an average of 60% of these trials disclose their biomarker approach, which highlights their importance in drug development and clinical research.

With the growth in the number of trials, tracking numerous biomarker strategies used across thousands of trials has become a daunting challenge for translational and clinical scientists.

There are over 2,300 lung cancer biomarkers, but currently only 22% of these are used in clinical trials across a range of capacities. This needs to increase as we are only just beginning to scratch the surface of the potential of biomarkers.

For example, they can be helpful in defining patient characteristics for either inclusion or exclusion of patients in a given trial, thereby selecting the most suitable cohort. Biomarkers can also aid in measuring the outcome as well as efficacy of the drug of interest.

This leaves over 1,800 preclinical lung cancer biomarkers with the potential to become effective clinical stage biomarkers in lung cancer. This presents a significant opportunity for pharmaceutical and biotech companies.

The effective implementation of the potential of biomarkers in developing new therapeutics goes hand in hand with a greater understanding of associated assays.

The US Food and Drug Administration defines an assay as an analytic procedure for detecting or measuring the presence, amount, or functional activity of a biomarker.

It is a component of a test, tool or instrument. Overall, assays provide the capability to detect a specific biomarker. Different assays have varying performance metrics, including sensitivity, specificity, precision, reproducibility and accuracy.

All of these parameters are highly important to consider when choosing the most optimal assay for a given biomarker of interest, which can differ in biology and sample type depending on the study.

Assays can also be developed as companion diagnostics (CDx), which help clinicians make crucial treatment decisions. CDx are able to detect specific biomarkers, allowing patients to be paired with the most effective drug for their cancer and increasing the likelihood of treatment success.

For an assay to receive CDx approval, it must first pass through a rigorous regulatory process to ensure its reliability and effectiveness. If successful, the approval is granted for specific biomarkers and an associated drug.

There is huge potential here as currently, as CDx approved assays make up just 5% of the available lung cancer assays. While CDx-approved assays demonstrate high accuracy and reliability, there are hundreds of other assays available with the potential to become decisive treatment tools for lung cancer patients.

Almost 500 assays are available for the lung cancer market, making uncovering new options and evaluating their associated performance metrics a challenging task.

Our work has collated detailed information regarding performance metrics, sample type, platform technology and regulatory requirements of a given assay collated in one database, which makes selecting the correct and most effective assay for a given research objective much easier.

Marking time

Range rover

Data day

Trial basis

Assays submission

Final analysis