To be precise

How oncology therapies can stand out in a diverse, uncertain landscape

The oncology field is rapidly evolving, particularly with the rise of precision medicines and new targeted treatments.

As the field becomes more crowded, many drug developers are diversifying their pipelines, pursuing various emerging therapies to mitigate the uncertainty surrounding the future success of any specific treatment approach.

In this dynamic environment, emerging oncology therapies can stand out to pharmaceutical companies seeking investment opportunities by focusing on two key elements: a target product profile (TPP) and established biomarkers for patient selection.

The value of these elements was highlighted in a 2024 survey of over 100 oncology developers’ clinical development strategies.

The importance of a target product profile

A TPP acts as a roadmap throughout the drug development journey. It is a structured summary of critical drug labelling details, established during the preclinical stages and refined as development progresses.

A precise and realistic TPP can define a clear path to market and commercial success by bridging the gap between research and development and commercial sectors.  Investors rely on the TPP to assess product viability and determine valuation parameters, even before clinical trial data becomes available.

Despite their importance, robust TPPs are not fully utilised by oncology developers, especially those in the early stages of development.

The survey revealed that over 60% of oncology drug developers differentiated their therapies based on their mechanism of action. However, less than half differentiated their therapies based on other TPP-relevant factors such as target population.

This underutilisation might stem from the complexity of crafting a TPP, particularly in early development. Developers must understand how the TPP will impact clinical development requirements, and how the therapy will fit into the future market post-approval.

Partnering with experts who have successfully developed similar therapies can provide invaluable experience, actionable real-world data and primary market research – all of which can guide the creation of a strategic TPP that maximises the likelihood of investor interest and market access.

Biomarker-based differentiation

The development of biomarkers for patient screening has become another crucial, but challenging, aspect of oncology therapeutic development.

In a reflection of the need for the co-development of screening biomarkers, 65% of survey respondents indicated that classifying cancer solely by tissue of origin was insufficient for their therapies.

However, identifying and implementing biomarkers that could predict a patient’s response to a therapy was challenging for 63% of respondents.

Over half (53%) reported that the difficulty in identifying predictive biomarkers limited the usefulness of their therapeutic approach.

The lag between treatment and biomarker development is partly attributed to the complex, non-binary relationships between individual biomarkers and useful information about a patient’s cancer or their treatment susceptibility.

Exploring new opportunities for artificial intelligence (AI)-driven biomarker detection and assessment could help bridge the gap between precision therapies and precision biomarkers.

In fact, almost half of the survey respondents (49%) identified this application of AI as a potential accelerator for oncology drug development.

While navigating the immediate challenges of proving their therapies’ efficacy, oncology developers must also consider how their therapies will compete in the future market and translate into clinical practice.

A well-defined TPP and the development of precision biomarkers are essential for ensuring that promising precision medicine approaches can be effectively implemented in clinical settings.

By focusing on these key elements, developers can enhance their chances of success in the evolving oncology landscape.

Learn more about de-risking clinical development of precision medicines in oncology in ICON’s whitepaper and survey report. Search ‘precision medicines oncology whitepaper icon’.

Daniel Ryan is Vice President, Project Delivery and Oncology Therapeutic Area Head at ICON. Go to iconplc.com