Ecco una descrizione concisa e adatta per Zenodo:
Title: TAK-928/IBI363: Mechanism, Clinical Evidence, and Molecular Patient Selection in IO-Resistant NSCLC
Description:
This narrative review synthesises the mechanistic rationale, preclinical foundations, and clinical evidence for TAK-928/IBI363 (Innovent Biologics/Takeda), a first-in-class PD-1/IL-2Rα bispecific fusion protein designed to overcome immune checkpoint inhibitor (ICI) resistance in advanced non-small cell lung cancer (NSCLC).
IBI363 simultaneously blocks the PD-1 checkpoint and delivers IL-2 signalling selectively biased toward the IL-2 receptor alpha subunit (CD25), targeting tumour-infiltrating T cells independently of PD-L1 expression status. Updated phase 1 proof-of-concept data presented at ASCO 2026 (Abstracts 2618, 8586, TPS8673) demonstrate a median overall survival of 18.2 months in IO-resistant squamous NSCLC — approximately double the historical docetaxel benchmark — with an 86.4% objective response rate in first-line combination with chemotherapy. The global phase 3 trial MarsLight-11 (NCT07217301) is now enrolling, supported by FDA Fast Track and China NMPA Breakthrough Therapy Designations.
The review additionally discusses molecular patient selection rationale, with focus on STK11, KEAP1, and KRAS co-alterations as candidate enrichment populations for primary ICI resistance.
Data incorporated through ASCO 2026 Annual Meeting (Chicago, 29 May – 2 June 2026).
Publication Date: 2026-06-13