Context announces Stemline received approval from U.S. FDA for ORSERDU

Context Therapeutics announced that its clinical trial collaborator, Stemline Therapeutics, a wholly owned subsidiary of The Menarini Group, received approval from the U.S. Food and Drug Administration, FDA, for ORSERDU for the treatment of postmenopausal women or adult men with estrogen receptor-positive, HER2-negative, Estrogen Receptor 1 gene-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 treatment, fulvestrant, in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. "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, 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." 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 with elacestrant vs SOC endocrine monotherapy, meeting both primary endpoints in all patients and in those patients whose tumors harbor ESR1 mutations.