Sign in Subscribe
Cancer

Shanghai Henlius Biotech Initiates Phase 3 Clinical Trial for Gastroesophageal Junction and Gastric Cancer Treatment

Strategic Insights

— 1 min read

Shanghai Henlius Biotech, a leading biopharmaceutical company, has announced the initiation of a phase 3 clinical trial for the treatment of gastroesophageal junction and gastric cancer in the United States. The trial, which is also ongoing in mainland China, Australia, Japan, and other countries, aims to evaluate the efficacy and safety of the company's recombinant humanized anti-HER2 monoclonal antibody injection, HLX22, in combination with Trastuzumab and chemotherapy.

The double-blind, randomized, controlled multicenter phase 3 study will enroll patients with HER2-positive, locally advanced or metastatic gastroesophageal junction and gastric cancer. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS), while secondary endpoints include investigator-assessed PFS, independent radiology review committee (IRRC) or investigator-assessed objective response rate (ORR), and duration of response (DOR). The trial has already dosed its first patient in the United States.

Key Takeaways:

  • The phase 3 clinical trial is evaluating the efficacy and safety of HLX22, a recombinant humanized anti-HER2 monoclonal antibody injection, in combination with Trastuzumab and chemotherapy.
  • The trial is being conducted in the United States, mainland China, Australia, Japan, and other countries.
  • The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS).
  • The secondary endpoints include investigator-assessed PFS, independent radiology review committee (IRRC) or investigator-assessed objective response rate (ORR), and duration of response (DOR).
  • The first patient in the United States has been dosed in the trial.

Statistics:

  • The trial is a double-blind, randomized, controlled multicenter phase 3 study.
  • The trial aims to enroll patients with HER2-positive, locally advanced or metastatic gastroesophageal junction and gastric cancer.
  • The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS), with a target duration of 24-30 months.
  • The secondary endpoints include investigator-assessed PFS, independent radiology review committee (IRRC) or investigator-assessed objective response rate (ORR), and duration of response (DOR).

Sources:

  • [Source: Shanghai Henlius Biotech, Inc., Announcement dated July 14, 2025, HKEX: 1999-HK0093818]
  • [Source: Hong Kong Exchanges and Clearing Limited, Link: https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0714/2025071400420.pdf]

Read more