Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib in Pre- and Post-Menopausal Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation as Detected by Guardant Health’s Guardant360 CDx Liquid Biopsy
- Prospective screening of subjects for ESR1 mutations will use the Guardant360 CDx blood test for companion diagnostic development
- Phase 3 study is supported by previously presented ELAINE-1 and ELAINE-2 Phase 2 study results
- Sermonix anticipates dosing the first patient in first half of 2023
Excerpt from the Press Release:
COLUMBUS, Ohio and PALO ALTO, Calif., March 09, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, and Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the initiation of a registrational Phase 3 clinical study comparing targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.
This global randomized study will enroll 400 subjects (pre- and post-menopausal women or men) with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation, who have progressed on palbociclib or ribociclib plus an aromatase inhibitor (AI) and up to one line of chemotherapy. Subjects will be randomized 1:1 to receive either lasofoxifene or fulvestrant, and both groups will also receive 150 mg of abemaciclib twice daily. Study subjects will be prospectively screened for an ESR1 mutation using the Guardant360® CDx liquid biopsy, a next generation sequencing (NGS)-based test that detects genomic alterations using circulating tumor DNA from blood. Eli Lilly and Company – which provided abemaciclib (Verzenio®) for the ELAINE-2 study – has entered into a new clinical trial collaboration and drug supply agreement with Sermonix and will provide abemaciclib for the ELAINE-3 study.
“The totality of data we have compiled on lasofoxifene to date, including from our completed ELAINE-1 and ELAINE-2 Phase 2 studies, show compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations,” said Dr. Paul Plourde, vice president for clinical oncology development at Sermonix.
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?