Pharmaceutical Market Europe • February 2025 • 18
THOUGHT LEADER
Standing out in a crowded precision oncology landscape
‘Oncology developers should be prioritising three factors to help their emerging therapy stand out’
By Bea Mann
A 2024 ICON survey of over 100 oncology developers’ pipelines reflected a diverse and highly complex landscape of emerging precision oncology therapies. These emerging therapies in oncology are displacing traditional toxic treatments such as chemotherapy and radiation.
However, the emerging therapies also share limitations. Most targeted cancer characteristics are not universal and therefore benefit is only seen in specific patient subpopulations. They also face high rates of drug resistance due to tumour heterogeneity, which limits the effectiveness of treatment. Many cancer survivors are now outliving what would have been a terminal cancer diagnosis through the implementation of successive or combination treatments rather than a singular therapy.
From a drug developer’s perspective, the specificity of emerging cancer therapies has contributed to an increasingly crowded market, in which many emerging oncology therapies can coexist. At the same time, many drug developers, uncertain about the future success of any single treatment approach, are diversifying their pipelines by pursuing multiple therapeutic indications concurrently, either as monotherapy or combination strategies.
Furthermore, establishing therapeutic efficacy and safety does not guarantee commercial success. Distributors may withdraw a drug despite regulatory approval if it is too expensive to run the confirmatory trials needed for distribution. Other drugs may be discontinued because of a lack of patients.
In this increasingly crowded market, oncology developers should be prioritising three factors to help their emerging therapy stand out beyond a compelling mechanism of action.
A competitive target product profile
A target product profile (TPP) is a structured summary of critical drug labelling details, established during 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 2024 ICON survey of oncology developers revealed that over 60% 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, real-world data and primary market research to guide the creation of a strategic TPP that maximises the likelihood of investor interest and market access.
Biomarker-informed treatment
The development of biomarkers for patient screening has become another crucial, but challenging, way to differentiate an emerging oncology therapy. In response to 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 treatment susceptibility. Exploring new opportunities for AI-driven biomarker detection and assessment could help bridge the gap between personalised treatment 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.
Combination therapy approaches
Combination therapy approaches can gain more leverage against cancer resistance mechanisms and enhance treatment efficacy by simultaneously blocking independent pathways of cancer survival or treatment resistance. Combination approaches to emerging therapies are so promising that some oncologists believe finding highly effective combinations of existing therapies could provide greater clinical benefit to patients than developing next-generation monotherapies. For example, researchers have observed synergistic effects on efficacy when combining mRNA-based cancer vaccines, which help immune cells identify cancer cells, with immune checkpoint inhibitors that combat a common method of immune evasion.
In the 2024 survey, most respondents (68%) reported developing at least one combination therapy. While such an investment may help insulate developers against the failure of any one therapeutic approach, it’s important to remember that pursuing multiple therapeutic approaches at the same time demands a broad and deep understanding of the oncology therapeutic landscape. It also requires an understanding of diverse scientific and practical limitations that emerging oncology treatments are likely to face during clinical development.
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 white paper and survey report.
Bea Mann is Senior Director, Oncology Drug Development at ICON
Pharmaceutical Market Europe (PME)
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