Context Therapeutics Announces FDA Approval of ORSERDU

Context Therapeutics

PHILADELPHIA, PA — Context Therapeutics Inc. (Nasdaq: CNTX) announced that its clinical trial collaborator, Stemline Therapeutics, Inc., a wholly-owned subsidiary of The Menarini Group, received approval from the U.S. Food and Drug Administration (FDA) for ORSERDU (elacestrant) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative (HER2-), Estrogen Receptor 1 gene (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. ORSERDU has shown improved efficacy over the current standard-of-care (SOC) treatment, fulvestrant, in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.1

“This is a watershed moment for the industry, which has spent the last 20 years trying to develop a next-generation endocrine therapy that is pharmacologically superior to endocrine monotherapies, including fulvestrant. ORSERDU has the potential to fundamentally change the treatment paradigm for patients with ESR1-mutated breast cancer, which is found in approximately 40% of the estimated 43,500 patients with metastatic hormone-driven breast cancer in the United States,” said Martin Lehr, CEO of Context Therapeutics. “Our collaboration with Menarini in the ongoing Phase 1b/2 ELONA trial is evaluating the potential of Context’s oral progesterone receptor antagonist onapristone extended-release (ONA-XR), to enhance ORSERDU’s activity in both ESR1-mutated and wild type metastatic breast cancer. Such a combination could potentially improve outcomes in patients without adding significant toxicity.”

According to the American Cancer Society, breast cancer is the second most common cancer among women, occurring in 1 in 8 women (13%) over the course of a woman’s lifetime, with ~280,000 new cases of invasive breast cancer and 51,400 cases of non-invasive breast cancer expected in 2023. Approximately 40% of patients with ER+, HER2- breast cancer will have ESR1 mutations, which is associated with poor prognosis. Endocrine monotherapy has displayed limited efficacy in ESR1 mutations.

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ORSERDU is approved under the FDA’s Priority Review and Fast Track designation based on the results of the registrational Phase III trial EMERALD, that demonstrated statistically significant progression-free survival (PFS) with elacestrant vs SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both primary endpoints in all patients and in those patients whose tumors harbor ESR1 mutations.

In the group of patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC. A post-hoc analysis of the PFS results based on the duration of prior CDK4/6i inhibitors (CDK4/6i) usage was presented at San Antonio Breast Cancer Symposium in December 2022. The median PFS was 8.6 months on elacestrant vs 1.9 months for SOC, in those patients whose tumors harbored ESR1 mutations and had been treated with a CDK4/6i for at least 12 months.

[1] FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. News Release. FDA. January 27, 2023. Accessed January 27, 2023.

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