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CPT Pharmacometrics Syst Pharmacol2026;15(8):e70304.August 1, 2026Journal Article

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology.

Mathilde Marchand1, Kenta Yoshida2, Antonio Gonçalves1, Rene Bruno3, Chunze Li2, Jin Y Jin2, Pascal Chanu4
1Certara Integrated Drug Development, Paris, France.
2Clinical Pharmacology, Genentech, South San Francisco, California, USA.
3R&B Pharmacometrics, Marseille, France.
4Clinical Pharmacology, Genentech-Roche, Lyon, France.
PubMed DOI

Abstract

The oncology market is evolving, with an increasing number of therapeutic options making the inference of treatment benefit from early development critical. The "Go" versus "No Go" decisions from such trials usually rely on probabilities of achieving meaningful improvements (effect sizes) in endpoints like objective response rate, tailored to products' profile, supporting faster transitions to con…

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