TL4: Considerations for clinical development plans of oncology drugs with a companion diagnostics
*Qi Xia, Roche/Genentech 

Keywords: companion diagnostic, clinical development plan, oncology, adaptive design, co-development with CDx

The Co-development of novel therapeutics and a companion diagnostic is playing an increasingly important role in drug development. Several clinical development plan options can be discussed. These options range from the lengthiest, e.g. traditional "Ph2 followed by Ph3" plan to the shortest, e.g. a "direct to Ph3" plan, with other options such as adaptive enrichement design (aka adaptive accrual design)that vary in terms of development timelines and risk level. A specific option needs to chosen based on the strategic context, the strength of the available data, and the performance of the diagnostic.