Biomarkers for Clinical Development | Industry Spotlights & Insight Articles

Improving Approaches for Patient Selection Using Immuno-Oncology Biomarkers

ICIs – immune checkpoint inhibitors – have changed the landscape of therapeutic treatment for cancer and improved survival rates for patients with advanced malignancies. However, the wide variability in clinical response is a significant limitation to treatment.

Immuno-oncology biomarkers are key for providing insights into the status of a patient’s individual cancer. 

Several biomarkers for patient selection in immunotherapy have been evaluated in prior and ongoing trials to investigate their predictive role of patient response. 

In the context of immunotherapeutic treatment, an ideal biomarker test accurately matches therapies with patients who will benefit from them. 

However, biomarkers for immunotherapies can be as unique as the indications they treat.

Unlike targeted therapies where diagnostic assays are simpler and more focused on specific genes, immunotherapy requires complex testing, with the assessment of multiple biomarkers of the tumour and tumour microenvironment. 

There have only been a few biomarkers approved for patient selection, such as PD-L1 IHC – the first predictive biomarker for checkpoint inhibitors. 

While these biomarkers identify certain patients and may work with certain drugs, the challenge lies in identifying patients who are likely to respond. 

Response rates will always be limited with a one-biomarker approach, especially for new biomarkers currently in development. 

Improving Success Rates for Immuno-Oncology Biomarkers 

Some tactics for improving patient success rates with immuno-oncology biomarkers include standardisation of strategies for biomarker selection. 

In particular, the tactic selection of combinatorial biomarkers approaches will improve the clinical benefit of ICI therapy for subsets of cancer patients. 

Biomarkers with high sensitivity and selectivity are required to identify subpopulations who are more or less likely to elicit a sustained response. 

Many patients who exhibit solid and hematologic malignancies have the potential to respond to ICI therapy. 

To overcome issues associated with immune-resistance, rational combinatorial approaches have been evaluated and implemented into clinical practice for various tumour types, such as checkpoint inhibitors used in combination with chemotherapy. 

Biomarkers ideally will be multifaceted in identifying patients who are most likely to derive a benefit from ICI while also limiting exposure and toxicity. 

Remembering the Importance of Patient Experience 

Clinicians assessing the validity of different approaches for immuno-oncology biomarkers should strive to be as accommodating as possible when working with their patients. 

This includes being transparent about a trial’s aims and probable success rate, as well as what it will involve. 

It is also important to learn about what an individual patient is willing and unwilling to do — if a particular treatment approach is particularly invasive the patient may not wish to go through with it. 

Surveys conducted before or after a trial can also provide valuable insights into best-practice approaches for patient selection in immunotherapy.

Ultimately, the work and research that goes into identifying immuno-oncology biomarkers for patient treatment assists in improving the patient’s overall quality of life, and this should always be an aspect of treatment. 

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