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.

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