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Retlirafusp Alfa: First Approval.

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Retlirafusp alfa, a novel bifunctional antibody, is now approved in China for advanced gastric cancer. This treatment targets PD-L1 positive tumors, offering a new first-line option for patients with specific cancer types.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Drug Development

Background:

  • Retlirafusp alfa is a bifunctional antibody fusion protein.
  • It combines PD-L1 targeting with TGF-β receptor II inhibition.
  • Developed by Jiangsu Hengrui Pharmaceuticals for solid tumors.

Purpose of the Study:

  • To summarize the development milestones of retlirafusp alfa.
  • To highlight its first approval in China for gastric cancer.
  • To detail its use in PD-L1 positive advanced GC/GEJA.

Main Methods:

  • Development of a bifunctional antibody targeting PD-L1 and TGF-β.
  • Clinical trials for efficacy and safety in gastric cancer.
  • Assessment of PD-L1 expression using a validated assay.

Main Results:

  • Retlirafusp alfa approved in China in January 2026.
  • First-line treatment for advanced, unresectable, recurrent, or metastatic GC/GEJA.
  • Effective in combination with fluorouracil and platinum-based drugs for PD-L1 positive CPS ≥ 1.

Conclusions:

  • Retlirafusp alfa represents a significant advancement in gastric cancer treatment.
  • The approval marks a key milestone for this novel immunotherapy.
  • It offers a new therapeutic strategy for PD-L1 positive advanced GC/GEJA patients.