A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Timeline

Start

2024-06-07

Primary completion

2026-11

Completion

2026-11

Outcome

Met primary endpoint

paper median progression-free survival was significantly longer with sac-TMT plus pembrolizumab than with pembrolizumab alone (not reached vs 5·7 months; PMID 42214392 ↗

paper stratified hazard ratio [HR] 0·35 [95% CI 0·26-0·47]; p<0·0001 PMID 42214392 ↗

release “The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA® [1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint.” kelun-biotech.com ↗

release “Following the meeting of the primary endpoint in the Phase III OptiTROP-Lung05 study for first-line PD-L1-positive NSCLC” kelun-biotech.com ↗

Publications

• Xiong A, Yao W, Zheng W, Yu Y, Chen P, Zhong H, Ge J, Wang H, Chen B, Wang H, Fan Y, Yang Y, Pu X, Song X, Wang Q, Du X, Huang Z, Li X, Luo H, Yao Y, Yu Q, Su C, He L, Jiang G, Cui J, Liu C, Yi T, Che G, Liu Z, Zhang L, Zhou M, Fang Y, Wei Y, Qing Y, Jin X, Zhou C. Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. Lancet. 2026 Jun 27;407(10548):2607-2619. doi: 10.1016/S0140-6736(26)00968-2. Epub 2026 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous
Subject	Sacituzumab Tirumotecan	Other / unclassified	4 mg/kg	Intravenous

Indications