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Opinion|Videos|January 20, 2026

Endpoints and Objectives: Capturing Efficacy, Safety, and Patient Experience

Author(s)Edgardo Santos, MD, FACP, FASCO

Discover how Copernicus enhances patient care with innovative treatments and supportive practices for advanced EGFR mutation cases.

Episodes in this series

1 expert is featured in this series.

EP. 1 Introducing COPERNICUS: Clinical Gaps and the Rationale for a New First-Line Strategy

1 expert is featured in this series.

EP. 2 Supportive Care Evidence Shaping COPERNICUS: Lessons From PALOMA three, COCOON, and SKIPPirr

1 expert is featured in this series.

EP. 3 Study Population and Cohort Design: Reflecting Real World EGFR Mutant NSCLC

1 expert is featured in this series.

EP. 4 Endpoints and Objectives: Capturing Efficacy, Safety, and Patient Experience

In this section, Dr Santos outlines the primary and secondary endpoints of COPERNICUS, highlighting a balanced assessment of efficacy, safety, and patient centered outcomes. Overall survival is emphasized as the key endpoint, supported by measures such as objective response rate, duration of response, and intracranial efficacy.

The discussion places particular focus on brain metastases, which occur more frequently in patients with EGFR mutations and are associated with poor prognosis. Dr Santos explains that evaluating intracranial response and progression free survival is critical to understanding the full impact of treatment. Safety endpoints include monitoring venous thromboembolic events and dermatologic toxicity, reflecting known risks associated with amivantamab based regimens.

Biological objectives are also incorporated, including analysis of circulating tumor DNA to explore resistance mechanisms and tumor evolution under dual EGFR inhibition. Patient reported outcomes are highlighted as an essential component of the study, reinforcing the emphasis on how patients perceive treatment burden, tolerability, and overall experience. This section positions COPERNICUS as a comprehensive evaluation of both clinical benefit and real world impact.

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The Rise of Novel HER2-Targeting Therapies in GEA: Mechanisms and Clinical Data

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