How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

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The clinical development strategy in oncology during the last decade has been substantially affected in several ways by the advent of immunotherapy1, and more recently, cell and gene therapy2 treatment options. 

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Tanja Obradovic, PhD
Vice president, Scientific Affairs, Medical Affairs Oncology, ICON Biotech
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Positive topline results have come out of the randomized phase II FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer who had received prior cyclin-dependent kinase 4/6 inhibitor-based treatment. 
The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. 
Tanja Obradovic, PhD
Vice president, Scientific Affairs, Medical Affairs Oncology, ICON Biotech

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