CSPC Group (01093): Phase I/II clinical study data of SYS 6010 combined with enlang subimab for the treatment of advanced driver-negative NSCLC without systematic treatment were presented in the form of an oral report at the 2026 World Lung Cancer Congress (WCLC)

Zhitong Finance App News, Shiyao Group (01093) announced that the Group has published phase I/II clinical data on SYS6010 combined with enranzubizumab for the treatment of driver-negative advanced non-small cell lung cancer (NSCLC) without systematic treatment at the 2026 World Lung Cancer Conference (WCLC) hosted by the International Association for Lung Cancer Research (IASLC).

At this conference, the group announced the results of the study's randomized controlled trial on SYS6010 combined with enranzubizumab injections to treat advanced driver gene-negative NSCLC without systematic treatment. The study evaluated two dosing regimens: SYS60104.2 mg/kg combined with enranzubizumab 360 mg every 3 weeks (plan 1); and SYS60103.6 mg/kg combined with enranzubizumab 240 mg every 2 weeks (plan 2).

As of July 13, 2026, a total of 123 participants were enrolled and treated in the above two dosing regimens. Among them, 62 were enrolled and treated with a median follow-up time of 10.8 months. The relevant safety and efficacy data are as follows:

. In terms of safety, the safety of the two administration regimens of SYS6010 combined with enranzubimab is generally manageable. The incidence of adverse events related to grade 3 treatment was 51.6% (Plan 1) and 52.5% (Plan 2), respectively, while the incidence of treatment-related adverse events leading to discontinuation of the drug was 9.7% (Plan 1) and 8.2% (Plan 2), respectively.

... In terms of effectiveness, both programs showed initial efficacy in the study population. Among them, those with high expression of non-squamous cell carcinoma and programmed death ligand 1 (“PD-L1”) benefited more significantly, and curative effects were seen in both squamous cell carcinoma and non-squamous cancer patients with high PD-L1 expression. The confirmed objective response rate (ORR) for the overall population and subgroups is shown in the following table:

Currently, the combination therapy of SYS6010 and enranzubizumab injection has entered phase III clinical trials, and the Group plans to develop its first-line treatment (NCT07633873) for PD-L1 positive locally advanced or metastatic NSCLC.