Phase 2 Trial Reports HB0025 Plus Chemotherapy in Advanced NSCLC

This open-label, multicenter phase 2 trial enrolled patients with stage IIIB/C or IV NSCLC without sensitizing EGFR, ALK, or ROS1 alterations at 13 hospitals in China. The 169 patients evaluable for efficacy received HB0025 at 10 or 20 mg/kg every three weeks with histology-specific chemotherapy: pemetrexed/carboplatin for nonsquamous disease or paclitaxel/carboplatin for squamous disease. After up to six chemotherapy cycles, HB0025 maintenance continued, with pemetrexed for nonsquamous disease. Primary endpoints were safety and investigator-assessed objective response rate (ORR).

Confirmed ORR in nonsquamous NSCLC was 36.4% with the 10-mg/kg dose and 57.1% with 20 mg/kg. In squamous NSCLC, ORR was 68.2% and 74.2%, respectively. Median progression-free survival was 12.52 months in the nonsquamous cohort and 14.78 months in the squamous cohort. Grade 3 or higher treatment-related adverse events occurred in 65.9% and 60.7% of patients, respectively, mainly hematologic; HB0025-related immune adverse events of any grade occurred in 23.5% and 25%.

The findings indicate antitumor activity but do not establish comparative benefit: the study was nonrandomized and had no control arm. The authors support further evaluation in randomized phase 3 trials; these results alone do not establish a change in clinical practice.