Strategies for commercialising oncology treatments for young adults

The oncology landscape is evolving, with a marked rise in cancer incidence among young adults globally. This challenges the traditional view of cancer as primarily an ailment of the elderly. The escalation of cancer cases in this demographic is a significant public health concern that requires tailored therapeutic approaches.

This article explores the imperatives and strategies for commercialising oncology treatments targeting young adults, highlighting the need for innovative regulatory and commercial strategies to ensure successful market entry and improved patient outcomes.

Rising cancer incidence among young adults

Recent data indicates a concerning increase in the incidence of various cancers among young adults, a trend that is gaining global attention. Even as cancer rates among older adults have stabilised, younger populations are experiencing a surge in cases, particularly in specific organ systems such as the gastrointestinal system, female reproductive organs, and the endocrine system. One example is colorectal cancer: once considered a disease of the elderly, it is now increasingly diagnosed in individuals under 50. This demographic shift in cancer incidence necessitates a re-evaluation of existing treatment paradigms.

Several factors are likely contributing to this trend, including genetic susceptibility, environmental toxins, and lifestyle choices, such as diet and physical inactivity. The financial burden associated with cancer in young adults is staggering, exceeding $1m¹ per patient when accounting for direct treatment costs and societal impacts. This economic strain is exacerbated by the underinsured status of many young adults, who often lack adequate coverage to manage the high costs of cancer care.

Cancer in young adults often presents differently than in older populations, both in terms of pathophysiology and aetiology. Younger patients may have different molecular signalling pathways, genetic mutations, and biomarkers that influence how they respond to treatment. For instance, breast cancer in young women is more likely to be diagnosed at a later stage and may be more aggressive, often presenting as triple-negative breast cancer, which has fewer treatment options.

Given these differences, there is an urgent need for therapies specifically designed to target the unique characteristics of cancer in young adults. This includes exploring novel drug combinations, personalised medicine approaches based on biomarkers, and treatment regimens that account for the generally higher tolerance levels and fewer comorbidities in younger patients. These tailored approaches have the potential to both improve patient outcomes and also offer compelling value propositions for drug developers and treatment providers.

Strategic considerations for commercialisation

Commercialising oncology treatments for young adults presents a distinct set of challenges and opportunities. To navigate this landscape effectively, drug developers must address several key considerations.

Accurately defining the target population is crucial. Unlike older individuals, young adults may present with cancers that have unique biological characteristics, necessitating specialised therapeutic approaches. Younger patients may also have a better tolerance of aggressive treatments. Recognising these differences and designing treatments that address them can set a product apart in the market.

Securing regulatory approval for treatments aimed at young adults may require innovative strategies. In the United Kingdom, mechanisms such as the early access to medicines scheme (EAMS) and other expedited review processes can accelerate the development and approval of drugs that address unmet needs in this population. For instance, demonstrating superior efficacy or a favourable safety profile in young adults could facilitate faster approval through these pathways.

Developing a compelling value proposition is essential for market success. This involves not only proving the clinical efficacy and safety of the treatment, but also showcasing its long-term benefits, such as improved quality of life and potential life-years saved. Given that young adults are often at pivotal stages of their lives, balancing their career and family responsibilities, treatments that restore or preserve their ability to work and live fully are likely to be highly valued by patients, providers, and payers alike.

Financial barriers are another significant concern. Many young adults face challenges in accessing cancer treatments due to inadequate insurance coverage. Hence, pricing strategies that improve affordability and expand access are crucial. Collaborative efforts with payers to secure favourable coverage terms and establish patient assistance programmes can help overcome these financial obstacles.

Clinical trials designed for young adults should reflect the unique aspects of cancer in this demographic. This includes addressing geographic variations in cancer incidence, ensuring diverse representation in trial populations, and focusing on endpoints that are particularly relevant to younger patients, such as long-term survival and quality of life.

Once a treatment is approved, ongoing efforts to collect real-world evidence on its efficacy and safety in young adults are vital. This continuous engagement with regulatory bodies and healthcare providers helps ensure that the treatment remains effective and accessible for the target population, supporting potential label expansions or updates.

The role of biomarkers in personalised medicine

The rise of personalised medicine offers significant potential for improving the outcomes of cancer treatments in young adults. Biomarkers, which are indicators of biological processes, can guide the development of therapies that are tailored to the specific genetic and molecular profiles of younger patients. For example, the presence of certain biomarkers in colorectal or breast cancer could indicate a higher likelihood of response to targeted therapies, leading to more effective and individualised treatment plans.

Moreover, younger patients often tolerate aggressive treatments better than older patients due to fewer comorbidities, making them more suitable candidates for novel therapeutic approaches as a clinical trial involving young adults may require fewer exclusion criteria. By leveraging biomarkers and other molecular indicators, drug developers can create treatments that not only target the disease more precisely, but also reduce the risk of adverse effects, thereby enhancing the overall benefit-risk profile of the therapy.

Conclusion

The increasing incidence of cancer among young adults is a clarion call for the oncology community to develop and commercialise treatments that address the unique needs of this demographic. As the landscape of cancer treatment continues to evolve, it is imperative that the healthcare industry remains proactive in addressing the challenges and opportunities presented by this growing patient population. By understanding the distinct characteristics of cancer in young adults, leveraging innovative regulatory strategies, and focusing on personalised medicine approaches, drug developers can start to better understand how treatment of cancer for this demographic can progress.