AACR 2025 | Evaluating the efficacy of lower-/shorter-course ICI regimens
Daniel Goldstein, MD, Davidoff Center, Rabin Medical Center, Tel Aviv, Israel, emphasizes the importance of critically evaluating trial design, pharmacokinetics, and data to inform treatment decisions, rather than being overly reliant on the dose used in the original registration trial. A wide body of evidence, including pharmacokinetic data and Phase I trial results, is needed to determine the optimal dose and regimen for individual patients. This approach allows for a more nuanced understanding of the checkpoint inhibitor’s effectiveness and potential side effects, rather than simply adhering to the protocol-driven design of the original trial. This interview took place at American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL.
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Transcript
What are the most important research questions? I mean, I think it requires looking with a critical eye at the design of the trials, looking with an open eye at the pharmacokinetics and the data, and just looking at the pharmacokinetic data and the Phase I trial data and other data that are around, and not just being totally, I want to say, wedded to what the actual dose was that was used in the trial itself...
What are the most important research questions? I mean, I think it requires looking with a critical eye at the design of the trials, looking with an open eye at the pharmacokinetics and the data, and just looking at the pharmacokinetic data and the Phase I trial data and other data that are around, and not just being totally, I want to say, wedded to what the actual dose was that was used in the trial itself. Because oftentimes the dose that was used in the registration trial, the Phase III trial, may well have been a dose that was much higher than necessary. So it requires looking at the totality of evidence and not just being purely protocol driven and only using regimens that are very strictly according to the Phase III trial design.
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