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SABCS 2019: approvazione di molecole in fase II per rispondere ad high unmet clinical need

By 13 Dicembre 2019Maggio 12th, 2021No Comments
Congressi

L’eco dei dati dello studio di fase II DESTINYBreast01, presentato a SABCS 2019, solleva una riflessione sull’approvazione sempre più frequente di nuove molecole sulla base di studi relativamente precoci. È corretto soprattutto se si cerca di rispondere ad high unmet clinical need e purché a questo faccia seguito la possibilità di avere dati aggiuntivi derivanti dalla pratica clinica, precisa Pierfranco Conte (Divisione Oncologia Medica 2, Istituto Oncologico Veneto, Università di Padova).

BIBLIOGRAFIA

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator’s Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1 – DS8201-A-U301 (DESTINY-B02) https://bit.ly/2O8F4G9

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane – DS8201-A-U302 (DESTINY-B03) https://bit.ly/2qL5JRw

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects – DS8201-A-U303 https://bit.ly/2Kl7lZ8