Immunotherapy in Recurrent and Metastatic Nasopharyngeal Carcinoma
In an international phase II trial (Mayo Clinic Phase 2 Consortium–NCI-9742) reported in the Journal of Clinical Oncology, Ma et al found that nivolumab (Opdivo) was active in previously treated recurrent or metastatic nasopharyngeal carcinoma.
Study Details
In the study, 44 evaluable patients were enrolled from 11 sites worldwide between October 2015 and June 2016 and treated with nivolumab at 3 mg/kg every 2 weeks until disease progression. All patients had to have received at least one prior line of platinum-based chemotherapy for recurrent disease. Most patients were Asian (82%) and male (78%).
The primary endpoint was objective response rate. Programmed cell death ligand 1 (PD-L1) expression and human leukocyte antigens (HLA) A and B in archived tumors as well as plasma clearance of Epstein-Barr virus DNA were assessed for association with outcome.
Response and Survival
Data were frozen in July 2017, with a median follow-up of 12.5 months among surviving patients. The objective response rate was 20.5% (including eight partial responses and one complete response). Nine patients (20%) received nivolumab for ≥ 12 months.
The 1-year overall survival rate was 59%, and the 1-year progression-free survival rate was 19.3%. No statistically significant correlation was observed between response and biomarkers. However, response was observed among 6 (33%) of 18 patients with PD-L1–positive tumors (≥ 1% expression in tumor cells and immune cells) vs 3 (13%) of 23 with PD-L1–negative tumors.
Loss of expression of one or both HLA class 1 proteins was associated with better 1-year progression-free survival vs expression of both (30.9% vs 5.6%, P = .01). No association was observed between survival and PD-L1 expression or plasma Epstein-Barr virus DNA clearance.
Adverse Events
Grade ≥ 3 adverse events considered possibly related to nivolumab occurred in 22% of patients and included colitis, diarrhea, fatigue, increased aspartate transaminase or alanine transaminase levels, neutropenia, hyponatremia, and lymphopenia. Adverse events led to treatment discontinuation in 10% of patients.
The investigators concluded: “Nivolumab has promising activity in [nasopharyngeal carcinoma] and the 1-year overall survival rate compares favorably with historic data in similar populations. Additional evaluation in a randomized setting is warranted. The biomarker results were hypothesis-generating and validation in larger cohorts is needed.”
The study was supported by the National Cancer Institute, Mayo Clinic Phase 2 Consortium, and grants from the Hong Kong University Grants Committee.
Brigette B.Y. Ma, MD, of the Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, is the corresponding author for the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
