The journey to a flexible care setting for high-dose monoclonal antibodies in oncology: Where do we stand and what comes next?

Today, with the increasing pressure on healthcare costs and resources and especially in light of the COVID-19 pandemic, the value of treatment management of cancer patients in a flexible care setting is broadly recognized. In such a setting patients and caregivers can choose the place of drug administration according to individual preferences and capabilities. Drugs may be administered in the clinic, a physician’s office, a community center closer to the patient’s home, or even, if permitted by the safety profile of the medicinal product, at the patient’s home.

Inherent to the need for parenteral administration, at home dosing is particularly complicated for high-dose monoclonal antibodies in cancer care. While in the past, these biotherapeutics had been dosed intravenously only, the development of high-concentration formulations and the co-formulation of the dispersion enhancer recombinant human hyaluronidase have greatly facilitated subcutaneous dosing. Subcutaneous bolus injections have been shown to be broadly preferred over more invasive intravenous infusions by patients and healthcare providers and to reduce drug administration related expenditures in the clinic. Dosing volumes for approved monoclonal antibodies in oncology range from 5 to 15 milliliters and still need to be administered in a controlled treatment setting and under the supervision of a healthcare provider.

This presentation will summarize the pharmacokinetic-based development pathway for subcutaneous dosing alternatives to intravenous treatments for monoclonal antibodies in oncology and highlight the challenges that still need to be overcome to enable dosing in a flexible care setting. Key focus areas for multidisciplinary researchers and drug developers that are currently in development, such as automated high-volume on-body delivery systems and connected devices with adherence trackers, dosing reminders, electronic patient diaries, and tools enabling a remote contact between patients and the treating physician will be described. The opportunities and challenges underlying the application of these novel technologies to support home- and possibly even self-administration of high-dose monoclonal antibodies will be discussed.