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05/10/2023 | Press release | Distributed by Public on 05/10/2023 04:42

Genor Biopharma Announces Poster of Results of the LEONARDA-1 Phase III clinical trial in advanced HR+/HER2- breast cancer at 2023 American Society of Clinical Oncology (ASCO)[...]

10 May, 2023

Genor Biopharma Announces Poster of Results of the LEONARDA-1 Phase III clinical trial in advanced HR+/HER2- breast cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Genor Biopharma Announces Poster of Results of the LEONARDA-1 Phase III clinical trial in advanced HR+/HER2- breast cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Shanghai, China, March 28, 2023 - Genor Biopharma (Stock code: 6998.HK) announced today that the results of the LEONARDA-1 phase III clinical trial in advanced HR+/HER2- breast cancer will be posted for the first time at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from June 2 to June 6.

LEONARDA-1 is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The trial was designed to evaluate the efficacy and safety of GB491 (Lerociclib) in combination with Fluvestra versus Fluvestran in the treatment of patients with Hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy.

At present, based on the results of LEONARDA-1, NMPA has officially accepted the new drug application for GB491 (Lerociclib) in combination with Fluvestran as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy.

The LEONARDA-1 data will be posted on Sunday, June 4 CDT in Hall D2 during ASCO's Metastatic Breast Cancer Poster Discussion Session.

Abstract Title:

LEONARDA-1：Phase III randomized study of lerociclib plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy.

Abstract Number: 1017

Poster Bd#: 238

About GB491 (Lerociclib)

GB491 (Lerociclib) is a highly selective oral CDK4/6 inhibitor for the treatment of breast cancer. The company in-licensed exclusive rights of GB491 (Lerociclib) from G1 Therapeutics, Inc. (Nasdaq: GTHX) in certain APAC countries excluding Japan in June 2020.