Discussion
NSCLC, cancers, Tumor, PK/PD, PD
CANCERS, TUMOR, NSCLC
This first-in-human phase I study of QL1604 showed that QL1604 was safe and well tolerated at doses from 0.3 mg/kg Q2W to 10 mg/kg Q2W, 3 mg/kg Q3W, and 200 mg Q3W. It is well-known that immunotherapy has received extensive attention and explosive development because of their good safety, durable responses, and application in a broad spectrum of cancers. However, immunotherapies are frequently constrained by their TRAEs (QL1604 demonstrated signal of antitumor activity in NSCLC and NPC. In patients who had metastatic NSCLC and had progressed on or after standard therapy, five of the 18 patients had a PR (ORR, 27.8%). In KEYNOTE-001, pembrolizumab resulted in an ORR of 19.4% (96/495) in patients with locally advanced or metastatic NSCLC (Compared with pembrolizumab (tThe efficacy, safety, and PK/PD data supported dosing of QL1604 every 2 or 3 weeks at doses of 3 mg/kg or 200 mg. No DLT was observed at the planned highest dose level 10 mg/kg. Thus, MTD was not determined yet. In addition, PRs were observed at all dose levels except 0.3 mg/kg Q2W. All doses were well tolerated. Tumor response and incidence of AEs were not dose dependent. Single dose of QL1604 exhibited a PK profile that is typical of mAbs with a dose-dependent increase in the PK exposure ranging from 0.3 mg/kg to 10 mg/kg. RO assessment by flow cytometry is a key PD biomarker, which reflects the relative binding of a therapeutic mAb to its cell-surface target (