retlirafusp alfa (SHR-1701)

We highlight that TGF-β-driven immune suppression and immune exclusion are often spatially organized within stromal niches, vary across indications, and are not always the dominant barrier even when PD-L1 is expressed. SHR-1701's approval provides proof of principle in a defined context and supports mechanism-aligned development using biomarker-driven selection, rational combinations and sequencing, and pharmacodynamic endpoints that directly test these assumptions.

P2, N=44, Active, not recruiting, Harbin Medical University

Patients who underwent surgery after induction treatment achieved clinically meaningful survival gains. Our findings support the use of neoadjuvant immunotherapy with a response-adapted surgical strategy as a promising approach for unresectable stage III NSCLC.

P2, N=84, Not yet recruiting, Fudan University

P2, N=33, Not yet recruiting, Tang-Du Hospital

P2, N=50, Not yet recruiting, Henan Cancer Hospital

P2, N=38, Not yet recruiting, Hebei Medical University Fourth Hospital

Dual-target ICI-chemo appears to be the most effective first-line strategy for AGC based on current indirect evidence, surpassing single ICI-chemo and dual ICI-based regimens. These findings support personalized therapy selection but await confirmation by head‑to‑head trials. Future studies should address CPS < 1 and explore optimized combinations to enhance outcomes.

P1, N=12, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University

P2, N=78, Not yet recruiting, Peking University Cancer Hospital & Institute

P2, N=18, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

In January 2026, retlirafusp alfa was approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced, unresectable, recurrent, or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJA) with a PD-L1 positive CPS ≥ 1, as assessed by a well-validated assay in China. This article summarizes the milestones in the development of retlirafusp alfa leading to this first approval for the treatment of advanced PD-L1 positive GC/GEJA.