LianBio Announces Clinical Supply Agreement with AstraZeneca in China to Evaluate BBP-398 in Combination with Osimertinib for EGFR-Mutated NSCLC

On July 12, LianBio announced that it had reached a clinical supply agreement with AstraZeneca in China to evaluate the safety and efficacy of SHP2 inhibitor BBP-398 in combination with AstraZeneca's epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations in a Phase I clinical study.

In the Asian region, approximately 40-50% of NSCLC cases have EGFR mutations, more than twice the rate in the United States. By simultaneously inhibiting SHP2 and EGFR, it is expected to prevent tumor formation and excessive cell proliferation.

The planned multicenter, open-label, Phase I trial aims to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BBP-398 in combination with osimertinib for patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The trial consists of two parts: a dose escalation phase and an efficacy expansion phase. LianBio expects to initiate the trial in the second half of 2023.

About BBP-398

BBP-398 is an SHP2 inhibitor under development for the treatment of refractory cancers. BBP-398 was co-developed by BridgeBio and MD Anderson Cancer Center (The University of Texas MD Anderson Cancer Center). SHP2 is a protein tyrosine phosphatase that regulates cell proliferation and survival by linking growth factor, cytokine, and integrin signals to the downstream RAS/ERK MAPK pathway. BridgeBio has entered into a strategic collaboration with LianBio to advance the clinical development and commercialization of BBP-398 in combination with other therapies for various solid tumors (such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer) in mainland China and other Asian markets. Additionally, BridgeBio is collaborating with other clinical partners to evaluate the efficacy of BBP-398 in combination with other drugs. For instance, in partnership with Bristol Myers Squibb, they are assessing the efficacy of BBP-398 combined with OPDIVO® (nivolumab) in patients with advanced solid tumors harboring KRAS mutations. In collaboration with Amgen, they are evaluating the efficacy of BBP-398 combined with Amgen’s KRAS G12C inhibitor LUMAKRAS® in patients with advanced solid tumors carrying KRAS G12C mutations.

Editor: Muyan

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