Real-world safety and effectiveness of nivolumab for recurrent or metastatic head and neck cancer in Japan: a post-marketing surveillance

Abstract

Background On the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting. Methods All patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 months to assess nivolumab’s safety, especially treatment-related adverse events (TRAEs) of special interest, and effectiveness. Results TRAEs occurred in 36.1% patients, with no new safety signals. The most common TRAEs with grade ≥ 3 were interstitial lung disease (1.2%), diarrhea (0.8%), and hepatic function abnormal (0.7%). Meanwhile, thyroid dysfunction (10.2%), hepatic dysfunction (5.3%), and interstitial lung disease (4.1%) were the most common TRAE categories of special interest. Although the median time to the onset of each TRAE category of special interest was mostly 1–2 months, most of them occurred throughout the observation period; nonetheless, the majority of patients recovered or remitted. The 6-month survival rate was 55.9%. Conclusion Japanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals. Clinical Trial Registration clinicaltrials.jp: JapicCTI-184071.

Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan

“…However, the sample sizes of CheckMate 205 ( n = 80) and ONO-4538-15 ( n = 17) were too small to detect these TRAEs. Nevertheless, these are not new safety signals for nivolumab having been reported previously [ 16 , 18 ].…”

“…Therefore, the higher incidence of liver-related TRAEs than in the previous clinical trials is partially responsible for the higher incidence of TRAEs in patients with prior allo-HSCT. Liver-related TRAEs were reported in nivolumab-treated patients with other carcinomas and are not new concerns [ 16 – 19 ]. We also noted that more than 80% of patients recovered/were recovering with appropriate treatment (Table 4 ).…”

Post-treatment Neutrophil/Lymphocyte Ratio Is a Prognostic Factor in Head and Neck Cancers Treated With Nivolumab

“…ICIs have unprecedentedly impacted the systemic therapy of various cancers and have provided long-term survival even in patients with advanced-stage cancer. In Japan, the anti-PD-L1 antibodies nivolumab and pembrolizumab were approved for treating RM-HNCs in 2017 and 2019, respectively, and their efficacy and safety have been validated in real-world settings (16)(17)(18). However, the treatment responses to ICI and clinical courses of treated patients are diverse.…”

Safety and effectiveness of nivolumab in Japanese patients with malignant melanoma: Final analysis of a post‐marketing surveillance

“…The incidence of grade ≥3 thyroid dysfunction was 0.6% in this PMS, 0% in the Japanese phase II studies, and 0.2% in the global phase III studies, showing a similar incidence. In a PMS of nivolumab for head and neck cancer, 13 a global phase III study of nivolumab for head and neck cancer (CheckMate 141), 14 and Japanese patients in CheckMate 141, 15 thyroid dysfunction occurred in 10.2%, 7.2%, and 11.1%, respectively, 13 which suggests that the incidence of thyroid dysfunction is not particularly high in Japanese patients. Similar results were reported in patients with non‐small cell lung cancer 16 .…”