RESUMEN
Targeted therapies continue to be key components of cancer treatment. New approaches to detection of acquired resistance at the genomic level, in combination with new therapies, help to overcome the challenges that are seen frequently, rapidly and broadly across tumor pathologies, and provide opportunities for cancer management. In the last several years, a new breed of modalities called immune checkpoint inhibitors have come to the forefront of clinically effective treatments. A plethora of rapid approvals and early access initiatives have seen anti-cytotoxic T-lymphocyte-associated antigen-4, and particularly anti-programmed death receptor-1 therapies, deployed in a number of tumor indications of high unmet need. With the rise of immune checkpoint inhibition, and the broader resurgence in the immuno-oncology field, we are facing challenges in the prediction of response.
Asunto(s)
Resistencia a Antineoplásicos/genética , Resistencia a Antineoplásicos/inmunología , Terapia Molecular Dirigida/métodos , Animales , Anticuerpos Monoclonales/uso terapéutico , Antineoplásicos/farmacología , Biomarcadores de Tumor/inmunología , Antígeno CTLA-4/uso terapéutico , Humanos , Inmunoterapia/métodos , Neoplasias/diagnóstico , Medicina de Precisión/métodos , Receptor de Muerte Celular Programada 1/uso terapéuticoRESUMEN
Medical history has not wandered far from its original aspirations of being personalized. Diagnostic capability has evolved from the metaphysical to the anatomical to the cellular and ultimately to the molecular level. Now that diseases can be subclassified into categories that indicate the course of disease and in some cases its likely response to treatment, there is a responsibility to act on that information. As more predictive biomarkers become clinically validated and as more targeted therapies become available, single marker companion diagnostics for specific drugs will be replaced by multiplex and multiparameter diagnostics that may be applicable across disease entities preserving sample, time, money and enabling rapid molecular taxonomy. We call this an ensemble relationship model between diagnostics and medicines.
RESUMEN
This article summarizes the broad messages from pharmaceutical and diagnostic companies on the collaborations required to support companion diagnostics. Since the groundbreaking herceptin HER2 diagnostic model in 1998, it has taken until 2011 for the US FDA to issue a draft guidance document, which was then immediately followed with approvals for two new drugs and their companion diagnostics. This conference summarized the current state of thinking in new projects and innovative technologies in pharmaceutical and diagnostic codevelopment. Attitudes are slowly changing and collaborations are rapidly ensuing, although the alignment between pharmaceutical and diagnostic understanding of value, timelines, outcomes and impact is difficult and remains a contentious area. The value of this conference has been to address these issues.