CSPC PHARMA(01093): Phase I/II clinical study data of SYS 6010 combined with enlonstobart for the treatment of driver gene-negative advanced NSCLC without prior systemic therapy was presented as an oral presentation at the 2026 World Conference on Lung Cancer (WCLC)

CSPC PHARMA (01093) announced that the Group has presented, in the form of an oral presentation at the 2026 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC), the Phase I/II clinical study data of SYS6010 combined with enlonstobart for the treatment of driver gene-negative advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. At this conference, the Group presented the randomized controlled trial results from this study on SYS6010 combined with enlonstobart injection for the treatment of driver gene-negative advanced NSCLC without prior systemic therapy. The study evaluated two dosing regimens: SYS6010 4.2 mg/kg combined with enlonstobart 360 mg administered once every 3 weeks (Regimen 1); and SYS6010 3.6 mg/kg combined with enlonstobart 240 mg administered once every 2 weeks (Regimen 2). As of July 13, 2026, a total of 123 participants had been enrolled and treated under the above two dosing regimens, including 62 in Regimen 1 and 61 in Regimen 2, with a median follow-up time of 10.8 months. The relevant safety and efficacy data are as follows: . In terms of safety, the two dosing regimens of SYS6010 combined with enlonstobart were generally manageable in safety, with the incidence of Grade 3 or above treatment-related adverse events at 51.6% (Regimen 1) and 52.5% (Regimen 2), respectively, while the incidence of treatment-related adverse events leading to discontinuation was 9.7% (Regimen 1) and 8.2% (Regimen 2), respectively. . In terms of efficacy, both regimens showed preliminary efficacy in the study population. Among them, the benefits were more prominent in the non-squamous carcinoma and programmed death-ligand 1 ("PD-L1") high-expression populations, and efficacy was observed in both PD-L1 high-expression squamous and non-squamous carcinoma patients. The confirmed objective response rate (ORR) in the overall population and each subgroup is shown in the table below: Currently, the combination therapy of SYS6010 and enlonstobart injection has entered Phase III clinical trials, and the Group intends to develop it for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC (NCT07633873).