18IN - Introduction: Recent failures in drug development for TN mBC

Date 30 September 2012
Event ESMO Congress 2012
Session How to integrate new drugs in the current therapeutic landscape of metastatic triple negative breast cancer
Topics Drug Development
Breast Cancer, Metastatic
Presenter Fabrice André
Authors F. André
  • Breast Cancer Unit, Department Of Medical Oncology, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif CEDEX/FR

Abstract

Several compounds have been developed in the recent years in triple negative BC. Although associated with promising initial results, they all failed to be fully implemented. Iniparib failed because the compound was not fully characterized, and because phase II trials amplified the effect of the drug. Olaparib failed because it targeted a rare population, and partially because its position in the therapeutic sequence was unclear. Finally, bevacizumab, although registered, was not fully optimized in the practice. Overall, these failures are illustrative of current questions in drug development. The first relates to the amount of information needed before moving to registration trials: is the compound characterized in preclinical models? Do we have evidence for bioactivity in early trials? Are phase II randomized trials optimal for decision to phase III? The second relates to the difficulties to develop drug in small populations defined by a biomarker: how to develop a predictive test? How to organize clinical research when less than 1 out of 10 patients screened will enter the trial? What is the path to registration for a drug targeting a rare population?

Disclosure

F. André: advisory board : SANOFI, Roche, Astrazeneca, novartis speaker bureau: Novartis