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Nivolumab shows antitumor activity in nasopharyngeal carcinoma
Nivolumab showed promising clinical activity among patients with pretreated recurrent or metastatic nasopharyngeal carcinoma, according to data published in Journal of Clinical Oncology.
“Nasopharyngeal carcinoma is endemic to parts of Asia and North Africa and is etiologically associated with the Epstein-Barr virus,” Brigette B.Y. Ma, MD, professor in the department of clinical oncology at Chinese University of Hong Kong, and colleagues wrote. “This virus-associated cancer represents the archetypal ‘inflamed tumor,’ which often exhibits a dense lymphocytic infiltrate and increased programmed death-ligand 1 (PD-L1) expression.”
In this phase 2, single-arm study, researchers assessed nivolumab (Opdivo, Bristol-Myers Squibb) monotherapy in 45 patients (median age, 57 years; 77.8% men) with recurrent or metastatic nasopharyngeal carcinoma. All patients had received at least one prior line of platinum-based chemotherapy.
Objective response rate served as the study’s primary endpoint. Secondary endpoints including survival and toxicity.
Median follow-up was 12.5 months for 28 alive patients.
Researchers observed an ORR of 20.5% among 44 evaluable patients, with one patient achieving a complete response and eight patients achieving a partial response.
Twenty percent (n = 9) of patients received nivolumab for more than 12 months.
Median OS was 17.1 months (95% CI, 10.8-not reached). Researchers observed a 1-year OS rate of 59% (95% CI, 44.3-78.5) and 1-year PFS rate of 19.3% (95% CI, 10.1-37.2).
A descriptive analysis showed patients who responded were more likely to have tumors with greater than 1% PD-L1 expression.
Thirty-three percent of patients with tumor PD-L1 expression of more than 1% responded to nivolumab compared with 13% of patients whose tumors did not express PD-L1. However, this difference did not reach statistical significance.
Additionally, a greater proportion of patients with a lack of expression in one or both human leukocyte antigen (HLA) class 1 proteins achieved 1-year PFS compared with patients who expressed both proteins (30.9% vs. 5.6%; P = .01).
The treatment appeared well tolerated, with 10.3% of patients discontinuing treatment due to an adverse event. Of the 45 patients evaluable for toxicities, 22.2% experienced a grade 3 or higher adverse event. The most common adverse events included colitis, diarrhea, fatigue, increase in aspartate transaminase or alanine aminotransferase level, neutropenia, hyponatremia and lymphopenia. One patient died of pulmonary tuberculosis during treatment.
“To our knowledge, this is the first completed report on the clinical activity and biomarker of response to nivolumab in patients with recurrent and metastatic nasopharyngeal carcinoma,” the researchers wrote. “There was no statistical association between PD-L1 expression in tumor cells or immune cells with survival and response to nivolumab; however, there was a higher proportion of patients with PD-L1-positive tumors who responded to nivolumab numerically in a descriptive analysis. Intriguingly, loss of HLA-A and HLA-B was associated with better survival than in patients with HLA-A- and HLA-B-intact tumors.” – by Cassie Homer
Disclosures: Ma reports honoraria from Merck Serono, Merck Sharp & Dohme, Novartis and Roche; consultant/advisory roles with Merck Serono, Merck Sharp & Dohme and Novartis; research funding from Novartis; and travel accommodations/expenses from Amgen. Please see the study for all other authors’ relevant financial disclosures.