(T1430-01-02) Insights from Drug Development Experts: Surveying Challenges and Outcomes for Large-Volume Subcutaneous Oncology Drugs

Purpose: With several well-known large-volume subcutaneous (SC) oncology drugs, such as daratumumab, trastuzumab, rituximab, nivolumab, and pembrolizumab, either approved or in trials, understanding how administration volume impacts drug development is critical. Patients generally prefer SC over intravenous administration. However, SC adoption is often limited by the perception that delivery volumes must stay below 3 milliliters without a permeation enhancer. This misconception hampers SC oncology drug prioritization and stifles innovation. To better understand these challenges, a survey was conducted to investigate decision-making processes surrounding large-volume SC oncology drug candidates.

Methods: The online survey, conducted November 20–26, 2024, targeted 80 drug development professionals with SC drug development experience equally representing new product planning, drug formulation, combination products, and clinical development. Of the participants, 43 primarily worked in oncology. The 23-item survey explored perceptions of SC volume thresholds, factors influencing the deprioritization of oncology drug candidates, the potential of large-volume delivery solutions in oncology, and how organizations track and revisit deprioritized candidates.

Results: The oncology respondents stated that 32% of drugs are abandoned due to challenges with drug volume. The most common reason for abandonment of the asset was lack of experience with large-volume formulations or devices. Similarly, the respondents stated that 29.5% of drugs are deprioritized due to difficulties in reducing subcutaneous drug volumes. When it came to deprioritizing assets, the primary reason was that large-volume drugs are only pursued if they address a unique unmet need regardless of the competitive landscape. Participants rated the commercial potential of these abandoned or deprioritized drugs at a 3 on a scale of 1-4 (1 = low potential, 4 = high potential) indicating that these drugs had worthwhile commercial potential. Fortunately, participants ranked the organizations willingness to revisit these drug candidates at a 3 on a scale of 1-4 (1=not open at all, 4=extremely open).

Conclusion: The results suggest that oncology molecules with worthwhile commercial potential remain unexplored within companies due to misconceptions around large-volume SC delivery, with a high willingness to revisit these candidates.

Acknowledgements: This research was funded by Enable Injections. Mehul Desai and Omar Rahman are employed by Enable Injections.