ISSUE: Overall survival (OS) is a final patient-centric outcome valued by clinicians and health technology assessment (HTA) agencies/payers. However, immature OS is a common issue for new oncology drugs, and using surrogate outcomes to support decision-making is a practical challenge. Dr. Xie will provide an overview of the issue, summarize recent research (using lung cancer and immuno-oncology as examples), and moderate the session. Dr. Zhang will present the pharmaceutical company perspective, looking at how such research is harnessed to demonstrate the value of innovative drugs, and evaluate the pros and cons of different methodologies, focusing on the challenges in early health benefit assessment for the pharmaceutical industry. Dr. Hales will provide a clinical view of surrogate outcomes and patient-centric outcomes and their relevance in clinical practice. Dr. Garrison will present different HTA/payers’ perspectives and discuss methods and evidence used by HTA/payers to assess the clinical benefits of oncology drugs in the context of economic evaluations. Panelists will debate the standard procedures to generate relevant evidence based on surrogate outcomes in oncology from three distinct perspectives and will invite the audience to share their views. OVERVIEW: Surrogate outcomes, such as response rate and progression-free survival, have been increasingly used by regulatory agencies to approve new oncology drugs. While much research has been devoted to associating surrogate outcomes with final patient-centric outcomes, such as OS, there has not been a standard method in oncology to establish the associations. In addition, there is little guidance on what evidence should be generated based on surrogate outcomes and OS for decision-making by clinicians and HTA/payers, partially due to inconsistent findings across treatments and disease areas. This panel will debate potential standard methodologies used to associate surrogate outcomes with OS and call for more guidance on evidence that can be accepted by clinicians and HTA/payers.