Antibody-drug conjugates (ADCs), which now account for approximately 20% of the clinical pipeline of antibodies for cancer, are comprised of three components: a monoclonal antibody chosen to target a specific receptor, a potent cytotoxic agent, and a linker that connects (conjugates) the antibody to the cytotoxin. From an efficacy perspective, there is substantial diversity of the drugs, linkers and drug-to-antibody ratios of the ADCs under development. From a safety perspective, the mechanisms of toxic effects are complex, with contributions from all three components of the conjugate. Successfully developing and obtaining regulatory approval for ADCs is therefore a challenging process. This White Paper discusses the role of real-world data to generate evidence that enables development decisions to be made earlier and more efficiently.
White Paper May 25, 2017