Sanofi Submits Clinical Application in China for Oral Selective Estrogen Receptor Degrader SAR439859

Text | Baihuawen

On February 26, Sanofi submitted an Investigational New Drug (IND) application in China for SAR439859 capsules, a selective estrogen receptor degrader (SERD). This drug has been positioned by Sanofi’s new CEO, Paul Hudson, as one of the group’s six key growth drivers for the future.

Phase II clinical data for SAR439859 as a second-line treatment in patients with ER+/HER2- breast cancer are expected to be released by the end of 2020; if successful, these results will support Sanofi’s submission of a New Drug Application in 2021.

Source: Sanofi Official Website

The first-generation SERD drug is fulvestrant, developed by AstraZeneca. It received FDA approval on April 25, 2002, for the treatment of ER+ breast cancer that has recurred following adjuvant endocrine therapy, as well as in combination with the CDK4/6 inhibitor palbociclib for the treatment of metastatic ER+/HER2- breast cancer that has progressed after endocrine therapy. ER+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases. EvaluatePharma recently reviewed the investigational drugs in this field, as detailed below:

Among them, Roche stated last month that its SERD drug RG6171 is about to enter Phase III clinical trials, which will be combined with CDK inhibitors for the first-line treatment of ER+/HER2- breast cancer, and claimed that it has the potential to become a best-in-class SERD drug.

Source: Roche Official Website

Another noteworthy point is Hengrui’s SHR9549, which is currently in Phase I clinical trials.