1458P - Pucotenlimab (HX008) - humanized anti-PD-1 monoclonal antibody plus pemetrexed and platinum as first-line treatment for advanced non-squamous non-small-cell lung cancer (nsqNSCLC): A single-arm multicenter phase II study

Background

Pucotenlimab is a novel anti-PD-1 IgG4 monoclonal antibody. Several clinical trials conducted in China have demonstrated its efficacy and safety in various solid tumors including gastric cancer and breast cancer. Here we report a phase II study result of pucotenlimab for nsq-NSCLC without EGFR/ALK mutations.

Methods

In this open-label phase II study, patients naive to systemic treatment were enrolled with histologically diagnosed stage IIIB or IV nsq-NSCLC. Patients were received intravenous Pucotenlimab 200mg Q3w for up to 35 cycles, combined with platinum + pemetrexed Q3W for 4 cycles and followed by maintenance pemetrexed Q3W (all intravenous). The primary endpoint was overall response rate (ORR) and safety, and the secondary endpoints were progression-free survival (PFS), duration of response (DOR) and overall survival (OS).

Results

From September 25th, 2020 to April 15th, 2021, a total of 43 patients were enrolled and followed up with a median of 13.1 months by the cut-off date (August 3th, 2022). 22 patients achieved partial response and 20 remained stable disease, respectively, contributing an ORR of 48.8% (95%CI: 38.9%, 59.2%) and a DCR of 95.3% (95%CI: 88.7%, 98.4%). The median PFS, DOR were 11.1 months (95%CI: 6.8, 14.4) and 13.9 (95%CI: 6.6, NE) months, respectively. The median OS was not reached. The common treatment-related adverse events (TRAEs) of any grade included anemia (79.1%), neutrophil count decreased (72.1%), white blood cell count decreased (67.4%) and platelet count decrease (53.5%). Neutrophil count decreased (32.6%) was the most reported grade 3/4 TRAE.

Conclusions

Pucotenlimab combined with pemetrexed plus platinum demonstrated promising efficacy and safety for the 1^st line nsq-NSCLC patients without EGFR/ALK mutations.

Clinical trial identification

NCT04750083.

Editorial acknowledgement

Legal entity responsible for the study

Taizhou Hanzhong Biomedical Co. Ltd.

Funding

Taizhou Hanzhong Biomedical Co. Ltd.

Disclosure

All authors have declared no conflicts of interest.