Patient, industry, and regulatory perspective on antibody‐drug conjugates dose optimization.

This article discusses the perspectives of patients, industry professionals, and regulatory bodies on optimizing the dosage of antibody-drug conjugates (ADCs) in oncology drug development. Patient perspectives are crucial in dosage optimization, as they can provide valuable information on quality of life, symptoms, and treatment outcomes. The article highlights a patient survey that reveals the importance of cure and improved quality of life for different subtypes of lymphoma. Industry professionals suggest various dosing strategies, such as body weight-based dose capping and response-guided dosing, to improve the benefit-risk profile of ADCs. Regulatory bodies emphasize the need for a wide dose range and investigation of dose schedules in early development to support exposure-response analyses and select optimal doses for registration trials. The article concludes that integrating patient perspectives, innovative study designs, and modeling approaches will be essential in maximizing the efficacy and safety of ADCs. [Extracted from the article]