LianBio Announces Clinical Supply Agreement with AstraZeneca in China to Evaluate BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations

LianBio, a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced a clinical supply agreement with AstraZeneca in China to evaluate the safety and efficacy of BBP-398, an investigational SHP2 inhibitor, in combination with AstraZeneca’s osimertinib, an epidermal growth factor receptor (EGFR) inhibitor, in a Phase 1 clinical study for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR mutations.

“In China, a disproportionately high percentage of NSCLC patients harbor EGFR mutations,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “While EGFR inhibitors are a critical part of the standard of care, most patients eventually acquire resistance to these therapies. We believe BBP-398 is a differentiated SHP2 inhibitor with the potential to restore sensitivity to EGFR inhibitors when used in a combination setting.”

EGFR mutations occur in approximately 40-50% of NSCLC cases in Asia, more than twice the rate observed in the United States. By combining SHP2 inhibition and EGFR inhibition, there is potential to prevent oncogenesis and overactive cellular proliferation.

The planned multi-center, open-label Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBP-398 in combination with osimertinib in patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial includes a dose escalation phase, followed by expansion cohorts. LianBio expects to initiate this trial in the second half of 2023.