Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

Hastening the search for novel treatment options therefore benefits from exploration of how these complex early and late-phase designs interact with each other, and what special design considerations can be implemented in early phases of clinical research for strategic late-phase clinical development. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

• Which dose-escalation designs are best suited for trials where the new treatment aspires to join a basket trial in later phases?
• Is data acquired using a complex early phase design like BLRM, TITE-BOIN, or dual-agent escalation recommended for use if a seamless design will thereafter be used to confirm efficacy?
• What are the adaptive strategies that best serve specific trials?

A recent webinar by Cytel’s Michael Fossler and James Matcham reviews the various trial design considerations confronting modern immunotherapy sponsors. After introducing the relative benefits of a number of algorithm-based and model-based escalation designs, Fossler and Matcham dive into strategic uses of target population, clinical pharmacology considerations, and exposure-response modeling for efficient clinical development.

Taken together, these questions can help sponsors have more in-depth conversations with their statistical design consultants about specific adaptive design and modeling strategies for their immunotherapies.

Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new eBook features a set of articles exploring various topics related to Bayesian statistical methods.

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