Adaptive clinical trials: Accelerating the future of immunotherapy

The last two decades have witnessed extraordinary progress in immunotherapy. Once considered a frontier science, immunotherapy is now a cornerstone of treatment for many cancers and other serious diseases. Every year, we see new therapies and indications approved, new mechanisms of action explored, and new hope delivered to patients worldwide. This rapid pace of innovation is a testament to the dedication of the global scientific and medical community.

Yet, as we celebrate these advances, we must also recognize the challenges in how we evaluate and deliver new treatments. One of the most significant barriers is the traditional clinical trial model. While these trials remain the gold standard, especially Phase 3 trials typically required to gain global health authority approval, they can be lengthy, rigid, and resource intensive. It is not uncommon for a single trial to take several years from initiation to completion, with additional time required for protocol development, regulatory review, data analysis and publication of trial results.^i,ii In a field where patient needs are urgent and scientific knowledge is evolving rapidly, this can delay access to potentially life-changing therapies.

The promise of adaptive clinical trials

Adaptive clinical trials are one of the strategies we have embraced to accelerate our approach to clinical research. Unlike traditional trials, which are conducted under a fixed protocol that requires formal amendments to introduce even small changes, adaptive trials are designed to be flexible from the start. They allow for preplanned modifications based on interim data—such as adjusting sample sizes, refining patient populations, or even adapting endpoints—while maintaining scientific rigor and integrity.^i,ii

This flexibility is particularly valuable in immunotherapy, where patient responses can be highly variable and the optimal treatment strategy may not be clear at the outset. Adaptive designs enable us to respond to emerging data in real time, making it possible to identify the optimal dose or combination more quickly while discontinuing approaches that are not showing benefit. This not only accelerates the pace of discovery but also ensures that patients are more likely to receive treatments that can truly help them.ⁱ

Making trials faster and more patient centric

One of the most compelling advantages of adaptive trials is their potential to shorten the timeline from discovery to approval. By incorporating interim analyses and decision points, adaptive trials can accelerate reaching critical inflection points months sooner than traditional designs. This means that promising therapies can move more quickly through the development pipeline and reach patients faster—a critical consideration in diseases where time is of the essence.

Adaptive trials also allow us to be more patient centric. For example, if early data suggest that a particular subgroup of patients is responding especially well, the trial can be enriched to focus on those individuals. Conversely, if a treatment arm is not performing as hoped, it can be discontinued.ⁱⁱ This approach not only improves the efficiency of research but also aligns with our ethical responsibility to prioritize patient wellbeing.

Embracing innovation at Immunocore

At Immunocore, we are harnessing, where appropriate, the power of adaptive clinical trials to advance the next generation of immunotherapies. Our teams design studies with built-in flexibility, such as using interim analyses and adaptive enrichment strategies to ensure our trials remain responsive to new data and focused on delivering meaningful outcomes. We also leverage advanced biostatistical methods, translational medicine insights, and real-world evidence to further refine our approach, ensuring that our research is both scientifically rigorous and relevant to the needs of patients.

This commitment to innovation is not just about speeding up the process—it is about making smart, more informed decisions at every stage of development. By embracing adaptive designs, we can better navigate the complexities of immunotherapy research, respond to the unique challenges of each disease, and ultimately, bring new hope to patients and their loved ones.

Looking ahead

The future of clinical research will include incorporating additional adaptive design elements. As the pace of scientific discovery continues to accelerate, we must ensure that our methods for evaluating new therapies keep pace. Adaptive clinical trials offer a powerful tool for doing just that—enabling us to respond to emerging data, focus on what works, discontinue what does not work as well, and ultimately deliver new treatments to patients faster than ever before.

At Immunocore, we are proud to champion this transformation. By combining scientific rigor with flexibility and a deep commitment to patient-centred care, we are helping to shape the next era in immunotherapy—one where innovation and compassion go hand in hand.

ⁱBhatt D, Mehta C. Adaptive designs for clinical trials. N Engl J Med 2016;375:65-74. doi: 10.1056/NEJMra1510061

ⁱⁱKaizer AM, Belli HM, Ma Z, Nicklawsky AG, et al. Recent innovations in adaptive trial designs: A review of design opportunities in translational research. Journal of Clinical and Translational Science 7: e125, 1–11. doi: 10.1017/cts.2023.537