8:00 am Morning Coffee & Check In
9:00 am Workshop A
Predicting & Mitigating Toxicities Associated With Novel Payloads in ADC Development
Synopsis
As ADC development expands to new payload classes, understanding how to predict, minimize, and manage toxicity is critical for early-stage drug development.
This interactive workshop will provide hands-on discussions and case studies to help:
- Preview the current landscape of novel payloads in preclinical and clinical development
- Understand how novel payloads impact ADC toxicity? Exploring the mechanisms of emerging payload classes, including their on- and off-target toxicity risks
- Case Study: What can we learn from past ADC failures? – Reviewing clinical and preclinical toxicity data to identify early warning signals for payload-driven toxicities
- Interactive Discussion: What are the key challenges in predicting payload toxicities and how do we tailor the preclinical safety characterization for novel payloads?
12:00 pm Lunch Break
1:00 pm Workshop B
Rethinking Patient Selection for Addressing Unique Toxicity Challenges From ADC Therapy – Balancing Risk & Access
Synopsis
Current ADC trials often exclude high-risk patients due to concerns about toxicity, but is this the best approach? This session will explore how we can better predict, manage, and personalize ADC-related toxicities rather than defaulting to exclusion.
Join this workshop to discuss topics such as:
Who is at higher risk of ADC toxicity?
- Understanding the role of clinical characteristics, pre-existing conditions, and biomarker-driven patient selection in predicting adverse events. Examples include: Patients with pre-existing lung disease and ADC-induced interstitial lung disease (ILD)
- Ocular toxicity risks in multiple myeloma patients receiving BCMA-targeting ADCs
Managing toxicity without eliminating patients from treatment
- Industry-wide, patients with risk factors are often excluded from trials. But should we:
- Implement risk-mitigation strategies (e.g. pre-treatment, monitoring, dose adjustments) instead?
- Develop guidelines for overlapping toxicities, such as ocular surface damage due to prior cancer therapies?
Moving toward a patient-first approach to ADC development
- Can the industry harmonize how toxicity is factored into patient selection? Rather than focusing on which ADC lacks a certain toxicity, how can we optimize how to manage different toxicities across ADC classes?