Oncology
Insights on the major trends in oncology including the development of targeted therapies in clinical trial designs and patient care.
The future of oncology biosimilars: Considerations for development through 2040
As patents for over 100 biologics—mainly in oncology—expire, biosimilars have a growing opportunity to expand access and enter established and underserved markets. This whitepaper explores the evolving oncology biosimilars landscape, regulatory strategies, challenges to market access, and innovations in post-market monitoring.
De-risking clinical development of precision medicines in oncology
This whitepaper reviews the most pressing challenges and opportunities facing the oncology therapeutic landscape in the emerging era of precision medicine, and reports on how those opportunities and challenges vary by organisational size and region.
ICON survey report: Innovation in oncology - Accelerating R&D in an evolving landscape
In Spring of 2024, ICON conducted a survey of 104 professionals engaged in oncology drug development in North America and Europe, representing organisations ranging from small to large biotech and pharmaceutical companies.
Advances in imaging biomarkers: Estimating drug efficacy with tumour growth rate modelling
This whitepaper compares the use of imaging biomarker methodologies such as RECIST 1.1 with novel tumour growth rate (TGR) modelling. Using this methodology eliminates the need for a comparable control arm which can reduce research costs. TGR modelling also more efficiently captures heterogeneous tumour measurements and whole-body tumour burden.
Strategies for commercialising oncology treatments for young adults
In this whitepaper we delve into the dynamic landscape of oncology treatments tailored specifically for young adults. As cancer incidence among young individuals surges globally, it's imperative to explore innovative strategies that address their unique needs and challenges.
Approaching the CAR T-cell therapy horizon
Approved CAR T-cell therapies have shown remarkable results in patients with certain types of blood cancers, but further innovations are needed before the technology can reach its full potential. In this whitepaper, we explore the most exciting clinical developments in CAR T-cell therapy, and relate them to limitations of approved therapies.
Research strategies to support the acceleration of oncology antibody drugs to market
This presentation will address important issues in antibody drug development, including choosing the right biomarker, drug formulation and manufacturing. It will also discuss critical aspects of clinical trial design and leveraging regulatory pathways, in addition to outlining the differences between fast track, break through therapy, priority review regulatory designations and accelerated approval pathways.
Oncology clinical development media contributions
Mission (im)possible? Efficient Global Antibody Drug Conjugate Product Approvals
Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. See page 42.
More than a statistic: What EU Joint Clinical Assessment changes for oncology patients
This article by Dr. Liz O’Brien of ICON, outlines how the EU Joint Clinical Assessment is reshaping global oncology drug development by driving earlier evidence generation, strengthening patient‑centered trial design and enabling more equitable access to innovative treatments across Europe. It underscores the growing emphasis on patient insights, PROs and cross‑functional evidence planning one year after JCA implementation.
Next-generation modalities, precision trials, and AI-driven breakthroughs in oncology
The panelists discussed promising scientific and strategic pathways in oncology, including next-generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.
Precision medicine meets machine learning: AI and oncology biomarkers
AI is redefining oncology biomarker discovery, unlocking new precision in patient selection and trial design. Explore how this evolving technology is shaping the future of cancer drug development.
Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
As patent expirations in oncology biologics increase, what are the opportunities, regulatory pathways and challenges this presents for developers? Publication: Citeline Generics Bulletin
What sets oncology biosimilars apart: Anticipating key challenges in the development landscape
With patent expirations encompassing numerous notable oncology biologics, opportunities for oncology biosimilar development are abundant. Publication: Drug Discovery & Development Magazine
Marking the Path Ahead: Integrating Oncology Biomarkers Into Clinical Development
In this article, ICON experts discuss strategies to implement biomarkers in clinical development, saving sponsors time and money while positioning therapies for success.
Combination therapies may be the future of oncology – How can we navigate development challenges today?
In this article, ICON experts discuss common ways oncology therapies are combined to achieve synergistic effects, and considerations oncology developers should employ to de-risk combination therapy development.
Standing out in a crowded precision oncology landscape
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.
Advances in imaging biomarkers: Estimating efficacy with tumour growth rate modelling
Imaging biomarkers are an essential part of oncology trials, tracking the efficacy of the new treatment and comparing it to the existing gold standard therapies. The insights gleaned from imaging biomarkers steer the course of oncology clinical trials, informing decision-making and endpoints. This article discusses the benefits of tumour growth rate modelling.
Oncology R&D: emerging therapies and new challenges
Worldwide demand for cancer therapies is set to soar – and biomanufacturers are in the spotlight. Explore emerging industry data to distinguish trends and prepare for the future of oncology.
To be precise: How oncology therapies can stand out in a diverse, uncertain landscape
Targeted product profiles and biomarkers for patient screening are essential elements of success for oncology treatment developers, according to our recent survey. This article explores why both prove challenging for drug developers.
Oncology blogs
Challenges of free payload concentration analysis in ADC studies
Analysing free payload concentration vital to assess the efficacy, toxicity and safety of ADC therapies but doing so requires sophisticated methods.
Rising to the challenge with innovative therapies
Accelerating access to innovative therapies is more than a regulatory ambition - it’s a strategic imperative for sponsors navigating global approvals.
How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA’s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
Oncology biosimilars on the rise: Key clinical development insights
As cancer treatment advances, biosimilars are becoming key players in oncology. While biologics have improved outcomes, their high costs remain a barrier. Biosimilars offer a more affordable alternative, closely replicating biologics whose patents have expired.
Solving common challenges to develop oncology combination therapies
ICON surveyed oncology developers in North America and Europe to explore challenges in therapeutic development. This article highlights key findings and offers strategies to de-risk combination therapy trials—explored further in our whitepaper.
Submission strategies for combined studies in the EU
In this article we look at how an oncology study sponsor managed their submission process which spanned more than 30 countries, many in the EU.
Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay
ICON's new RNA-based NGS assay improves CML monitoring, offering higher sensitivity and specificity, including for the identification of typical and atypical BCR::ABL1 transcript types and the detection of TKI resistant mutation.
Navigating shifting paradigms in dose optimisation and dose selection for oncology therapeutics
MTD is increasingly seen as suboptimal for emerging oncology therapies, which lack chemotherapy’s generalised cytotoxic effects. More contemporary dose-selection designs can now identify the lowest dose of an oncology therapy with the highest rate of efficacy that is tolerable for patients.
Innovations contributing to the reemergence of antibody drug conjugates
ADC candidates that address the limitations of their first-generation predecessors are receiving approvals, and a new wave of ADCs are in clinical development. Read the blog to explore the innovations contributing to the re-emergence of ADCs.
Navigating oncology development decisions for long-term success
Read the blog to learn how to navigate key challenges in oncology and the important decision points including early clinical development, robust registrational strategy and late-stage development.
Leveraging healthcare intelligence to increase diversity of oncology clinical trials
New regulatory requirements for diversity require sponsors to submit a diversity action plan alongside key trial documents to the FDA. Read the blog to learn how healthcare intelligence can be leveraged to increase diversity in oncology clinical trials.
Expanding CAR T-cell Therapy into solid tumours
In this blog, learn more about a range of approaches that researchers are taking to improve the efficacy and safety of CAR T-cell therapies in solid tumours.
Receive more insights on oncology from ICON
Please visit ICON's Preference Centre and select 'oncology' under 'Therapeutic Areas of Interest' to receive new insights on oncology.
ICON's Oncology capabilities
Oncology services
ICON’s Oncology Solution expedites every aspect of a cancer drug trial. It combines global experience in all Phases of oncology drug development (including early phase, immuno-oncology and cell and gene therapies) with expertise in tumor imaging, laboratory (including PK/PD and Biomarkers) IVRS, central data management, electronic data capture and regulatory oncology issues.