BeiGene’s Innovative Approach to HR+/HER2- Metastatic Breast Cancer: A Phase 1 Study Update

Beigene, Ltd. ((ONC)) announced an update on their ongoing clinical study.

BeiGene, Ltd. is conducting a Phase 1 clinical study titled ‘A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer.’ The study aims to evaluate the safety and effectiveness of BGB-21447, a Bcl-2 inhibitor, in combination with fulvestrant, with or without BGB-43395, in treating HR+/HER2- metastatic breast cancer, which is a significant cause of breast cancer-related deaths.

The interventions being tested include BGB-21447, an oral Bcl-2 inhibitor, fulvestrant, an estrogen receptor blocker administered via intramuscular injection, and BGB-43395, an oral CDK4 inhibitor. These drugs are intended to disrupt cancer cell survival pathways, potentially improving treatment outcomes for patients.

The study is designed as an interventional, non-randomized, sequential model with no masking, primarily focused on treatment. It involves experimental arms testing different combinations of the drugs to determine optimal dosing and safety.

Key dates for the study include an actual start date of February 4, 2025, with the latest update submitted on June 23, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates to stakeholders.

This clinical study update could influence BeiGene’s stock performance and investor sentiment positively, as successful outcomes may enhance the company’s market position in the oncology sector. The study’s focus on HR+/HER2- metastatic breast cancer, a prevalent and challenging condition, adds to its potential market impact.

The study is currently recruiting, with further details available on the ClinicalTrials portal.