On 27 January, the US FDA approved Stemline Therapeutics’ (wholly owned US subsidiary of the Menarini group) elacestrant (Orserdu) as second-line treatment for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer (mBC), making it the first oral selective estrogen receptor degrader (SERD) to be approved for the indication and the first-ever approved drug for cases with the ESR1 mutation (~40%of all cases in this category). We see this as a material development for Context Therapeutics, which is currently undertaking Phase Ib trials (ELONA trial in collaboration with Menarini) for its drug ONA-XR in combination with elacestrant for the treatment of second/third-line HR+/HER2- mBC. ONA-XR has previously shown promising preclinical data in combination with anti-estrogen therapy, and improved efficacy, if demonstrated in the ELONA trial, should open the door for partnering prospects and create significant market opportunity for Context, in our opinion.
31 Jan 2023
Context Therapeutics - Elacestrant approval shot in the arm for ELONA trial
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Context Therapeutics - Elacestrant approval shot in the arm for ELONA trial
Context Therapeutics, Inc. (CNTX:NAS) | 0 0 0.0%
- Published:
31 Jan 2023 -
Author:
Soo Romanoff -
Pages:
2
On 27 January, the US FDA approved Stemline Therapeutics’ (wholly owned US subsidiary of the Menarini group) elacestrant (Orserdu) as second-line treatment for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer (mBC), making it the first oral selective estrogen receptor degrader (SERD) to be approved for the indication and the first-ever approved drug for cases with the ESR1 mutation (~40%of all cases in this category). We see this as a material development for Context Therapeutics, which is currently undertaking Phase Ib trials (ELONA trial in collaboration with Menarini) for its drug ONA-XR in combination with elacestrant for the treatment of second/third-line HR+/HER2- mBC. ONA-XR has previously shown promising preclinical data in combination with anti-estrogen therapy, and improved efficacy, if demonstrated in the ELONA trial, should open the door for partnering prospects and create significant market opportunity for Context, in our opinion.