Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Umbrailisib and Duvelisib Clinical Trials

Timothy Smith, Eli Paul, Griffin Hughes, Chase Ladd, Andriana Pena, Ryan McIntire, Brooke Gardner, Farzeen Syed, Jordan Tuia, Alyson Haslam, Vinay Prasad, Matt Vassar

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Abstract

Objective: Assess the risk/benefit profiles of duvelisib and umbralisib through a comprehensive analysis of their clinical trial landscape.

Methods: We performed a literature search for duvelisib and umbralisib clinical trials involving monotherapy or combination therapy for cancer treatment. Key trial characteristics, median overall survival, median progression-free survival, adverse event rates, and overall response rates were extracted. Primary trial endpoints were recorded as positive if trials met their prespecified primary endpoint, negative if the primary endpoint was not met or the drug was deemed overly toxic, or indeterminate.

Results: Of the 18 studies included, 12 were single-arm trials and only one was a randomized controlled trial. Evaluation of primary endpoints and safety outcomes revealed 11 (61.1%) positive and 5 (27.8%) negative outcomes. Evaluation of primary endpoints and toxicity profile showed 61% of trials had positive outcomes. However, 1,564 grade 3-5 adverse events were reported across 1,549 participants enrolled in all trials. Median progression-free survival was 15.3 months and median overall survival was 25.7 months. Median partial response rate was 48.0%, complete response rate was 7.3%, and objective response rate was 55.3%.

Conclusions: Our study aimed to evaluate the risk/benefit profile of these drugs and represents the first thorough investigation of their clinical trial portfolio. Our results demonstrate the potential for future use of duvelisib and umbralisib if adverse events can be minimized. We highlight concerns regarding the accelerated approval pathway and conclude that reform to the accelerated approval pathway should take precedence to ensure patient safety.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023

Conference

Conference7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics
Abbreviated title7th Joint Annual Research Meeting
Country/TerritoryUnited States
CityTulsa
Period21/07/2321/07/23

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