Discussion

Recent approvals for oncology drugs have seen an increasing proportion directed to specific genetic targets i with a companion diagnostic test. This presentation compares and contrasts the discovery and development of gefitinib - the first EGFR tyrosine kinase inhibitor and AZD9291, an irreversible inhibitor of both sensitizing and resistant mutated EGFR. This demonstrates how the better understanding we now have of the genetic changes driving the cancer growth and the biochemical structure and function of the mutated proteins, has lead to a much faster developmental path with higher likelihood of success in pivotal trials. I will also discuss the emerging trend of the development of ‘basket’ studies which include one or more screening tests for multiple genetic aberrations and the direction of patients to one of several arms of a clinical trial based on the specific aberration in their tumour.