Abstract 909P
Background
Nasopharyngeal carcinoma (NPC) is a rare, but geographically distributed tumor with a high incidence in South China and Southeast Asia. Penpulimab had demonstrated encouraging anti-tumor activity and favorable safety profile in NPC patients with disease progression after ≥ 2 prior lines of therapy in the previous report (Chen et al, J Immunother Cancer 2020). We updated the latest long term efficacy and safety data.
Methods
Eligible patients included metastatic NPC after failure of at least two lines of prior chemotherapy, age 18–75 years with a WHO performance status of 0 or 1, and had not received PD-1/CTLA-4 antibody treatment. Patients received penpulimab 200 mg every 2 weeks until progression or unacceptable toxicity. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1. The secondary objectives were Disease control rate (DCR), Duration of response (DoR), Progression-free survival (PFS), Overall survival (OS) and safety.
Results
130 patients were enrolled and 111 patients met the definition of full analysis set (FAS). As of data cutoff on February 3rd, 2021, the median follow-up time was 14.7 months (0.9-22.3 months). Based on IRRC assessment, the ORR was 29.7% (33/111, 95% CI: 21.4%-39.1%); The DCR was 49.5% (55/111, 95% CI: 39.9%-59.2%); Median DoR data were not mature, and the 9-month DoR rate was 77.6% (95% CI: 52.6%-90.4%). Median PFS was 3.65 months (95% CI: 1.87- 6.60 months) and median OS was 18.63 months (95% CI: 14.09-NE months), assessed by IRRC. Treatment-related adverse events (TRAEs) of any grade were observed in 90 (69.2%) of the 130 patients. The incidence of ≥ Grade 3 TRAEs was only 8.5% (11), included hepatic function abnormal, death, and rash (2 for each) and others (5). Treatment interruption and discontinuation due to TRAEs occurred in 19 (14.6%) and 4 (3.1%) patients, respectively.
Conclusions
Penpulimab has shown long term efficacy and well tolerance in the treatment of metastatic nasopharyngeal carcinoma who failed second-line (platinum-containing chemotherapy) and higher chemotherapy.
Clinical trial identification
NCT03866967.
Editorial acknowledgement
Legal entity responsible for the study
Akeso Biopharma, Inc.
Funding
Akeso Biopharma, Inc.
Disclosure
All authors have declared no conflicts of interest.