Real-World Findings Support Nivolumab Use in HNSCC

Nivolumab demonstrated durable response and overall survival rates in a real-world analysis of patients with platinum-refractory, recurrent/metastatic head and neck squamous cell carcinoma.

Nivolumab (Opdivo) demonstrated durable response and overall survival (OS) rates in a real-world analysis of patients with platinum-refractory, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).1 These findings support the CheckMate-141 safety and activity data in this population, which historically has had a poor prognosis.

In this analysis, investigators looked to evaluate the safety of nivolumab in patients with HNSCC in the real-world setting. The observational, retrospective, multicenter, noninterventional study collected real-world data from patients treated with nivolumab between April 1, 2017, and May 30, 2018, in Spain, where the agent has been available for use since April 2017. At the time of the report, which was presented at the 2018 ESMO Congress, 41 of the 50 patients treated at 7 centers were evaluable.

Efficacy findings showed a disease control rate of 48.8%, partial responses in 11 patients, and stable disease in 9 patients. The median progression-free survival was 3.4 months (95% CI, 1.3-5.6) and the median OS was 8.8 months (95% CI, 3.8-13.9). The 6-month OS rate was 55%, and the 9-month OS rate was 45%. Median time to response was 12 weeks.

Safety findings of the real-world data showed that there were no grade 3/4 immune-related adverse events (irAEs). Grade 1/2 irAEs were observed, however, including asthenia (29.3%), arthralgia (14.6%), hypothyroidism (14.6%), rash (2.4%), anemia (2.4%), and pneumonitis (2.4%). No irAEs required treatment discontinuation.

“To date, there are few published data on the use of nivolumab in routine clinical practice in [platinum-resistant relapsed/metastatic] HNSCC patients. Our results seem to confirm efficacy data of CheckMate-141 in a real-world setting, with a serious irAE rate lower than previously reported,” wrote principal investigator Gema Bruixola, of the Hospital Clínico Universitario de Valencia, Spain, and co-investigators.

The phase III randomized CheckMate-141 study showed a 32% reduction in the risk of death compared with investigator’s choice of therapy for patients with metastatic or recurrent HNSCC.2 During a presentation of long-term data at the 2018 American Association for Cancer Research Annual Meeting, investigators said that the safety data for the 2 arms remained consistent with longer follow-up.

Findings from CheckMate-141 showed a median OS of 7.7 months (95% CI, 5.7-8.8) with nivolumab compared with 5.1 months (95% CI, 4.0-6.2) for investigator’s choice of therapy (HR, 0.68; 95% CI, 0.54-0.86). The 2-year OS rate was 16.9% with nivolumab (95% CI, 12.4%-22.0%) versus 6% in the control arm (95% CI, 2.7%-11.3%).

Regarding safety, the CheckMate-141 trial results showed that patients with nivolumab had few AEs. Overall, grade 3/4 treatment-related AEs were experienced by 15.3% of patients treated with nivolumab compared with 36.9% of those in the control arm.

Patients included in the real-world analysis were adults aged 18 years or older diagnosed with platinum-refractory recurrent or metastatic HNSCC before May 2017. These patients must have initiated nivolumab treatment at a dose of 3 mg/kg every 2 weeks during the observation period of April 1, 2017, to May 30, 2018. Patients who were enrolled on a clinical trial of a cancer therapy, those with a history of autoimmune disease, or those with known immunosuppression were excluded from this analysis.

“These promising results encourage the use of nivolumab in this population, but further follow-up and more mature data are still needed,” concluded Bruixola and colleagues.


  1. Bruixola G, Caballero Daroqui J, Cunquero Tomas AJ, et al. Safety and efficacy of nivolumab (nivo) in platinum-refractory recurrent/metastatic head and neck squamous cell (PR R/M HNSCC) patients (pts): real-life experience. Ann Oncol. 2018;29(Suppl 8):viii372-viii399. doi: 10.1158/1538-7445.AM2018-CT116.
  2. Ferris RL, Blumenschein GR, Fayette J, et al. Nivolumab (Nivo) vs investigator’s choice (IC) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): 2-yr outcomes in the overall population and PD-L1 subgroups of CheckMate 141. In: Proceedings from the American Association for Cancer Research Annual Meeting 2018; April 14-18, 2018; Chicago, Illinois. Abstract CT116. doi: 10.1158/1538-7445.AM2018-CT116.