Hansoh Pharma Initiates Ib/III Clinical Trial of China's Most Advanced c-Met/EGFR Bispecific Antibody HS-20117

May 18, 2024 09:56 CST Updated 09:56

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On May 16, the Clinicaltrials website showed that Hansoh Pharma's c-Met/EGFR bispecific antibody HS-20117 initiated a Phase Ib/III study, becoming the domestically produced c-Met/EGFR bispecific antibody with the fastest development progress.

This study plans to enroll 1,080 treatment-naïve patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who are unsuitable for surgery or chemoradiotherapy and carry EGFR mutations (Exon19 deletion or Exon21 L858R substitution).

The study is divided into two parts: a Phase Ib dose-expansion study and a Phase III confirmatory study. The Phase Ib study aims to evaluate the efficacy, safety, tolerability, PK properties, and immunogenicity of HS-20117 in combination with Aumolertinib and to confirm the recommended Phase III dose (RP3D). The Phase III study aims to assess the efficacy and safety of HS-20117 in combination with Aumolertinib versus Aumolertinib alone in this patient population.

The primary endpoint of the Phase Ib study is the investigator-assessed objective response rate (ORR), and the primary endpoint of the Phase III study is the progression-free survival (PFS) assessed by the Independent Review Committee (IRC).

HS-20117 is a c-Met/EGFR bispecific antibody introduced by Hansoh Pharma from Promab Biotechnologies for 1.468 billion yuan, which entered the IND stage in March 2023.

Currently, there are 12 c-Met/EGFR targeted drugs in clinical development globally, seven of which are c-Met/EGFR bispecific antibodies. Amivantamab (Johnson & Johnson) is the only marketed c-Met/EGFR bispecific antibody so far, and its subcutaneous injection formulation has entered Phase III trials. EpimAb Biotherapeutics and Betta Pharmaceuticals have also developed c-Met/EGFR bispecific antibodies, with their products still in the early stages.

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