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Published on: April 22, 2019
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck
Robert L Ferris1, George Blumenschein1, Jerome Fayette1
1From the University of Pittsburgh Medical Center and Cancer Institute, Pittsburgh (R.L.F.); the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.B.); Centre Leon Berard, Lyon (J.F.), Centre Antoine Lacassagne, Nice (J.G.), and Institut Gustave Roussy, Villejuif (C.E.) - all in France; Stanford Cancer Institute, Stanford, CA (A.D.C.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Tumori, Milan (L.L.); Institute of Cancer Research-Royal Marsden National Institute for Health Research Biomedical Research Centre, London (K.H.); University Hospital Essen, Essen, Germany (S.K.); University of Chicago, Chicago (E.E.V.); University of Michigan, Ann Arbor (F.W.); Winship Cancer Institute of Emory University, Atlanta (N.F.S.); Hospital Universitario 12 de Octubre, Madrid (L.C.I.D.); Dana-Farber Cancer Institute, Boston (R.H.); Universitätsspital Zurich, Zurich, Switzerland (T.R.); Kobe University Hospital, Kobe (N.K.), and National Cancer Center Hospital East, Kashiwa (M.T.) - both in Japan; Bristol-Myers Squibb, Princeton, NJ (M.M., M.L., W.J.G., J.K., J.W.S.); and Ohio State University, Columbus (M.L.G.).
Background:
Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition.
Methods:
In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival. Additional end points included progression-free survival, rate of objective response, safety, and patient-reported quality of life.
Results:
The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy. Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01), and the estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%). The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32). The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy. The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group. Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group. Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group.
Conclusions:
Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy. (Funded by Bristol-Myers Squibb; CheckMate 141 ClinicalTrials.gov number, NCT02105636 .).
Insights
Nivolumab significantly improved overall survival for patients with recurrent head and neck cancer after chemotherapy. This immunotherapy demonstrated better outcomes and fewer severe side effects compared to standard treatments.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Head and neck squamous-cell carcinoma (HNSCC) that recurs or metastasizes after platinum chemotherapy has a poor prognosis.
- Limited therapeutic options exist for patients with platinum-refractory recurrent or metastatic HNSCC.
- Nivolumab, an anti-programmed death 1 (PD-1) antibody, offers a potential treatment avenue.
Purpose of the Study:
- To evaluate the efficacy and safety of nivolumab compared to standard systemic therapy in patients with platinum-refractory recurrent or metastatic HNSCC.
- To assess overall survival (OS) as the primary endpoint.
- To investigate secondary endpoints including progression-free survival (PFS), objective response rate (ORR), safety, and quality of life.
Main Methods:
- A randomized, open-label, phase 3 trial (CheckMate 141) involving 361 patients.
- Patients were assigned 2:1 to receive nivolumab (3 mg/kg every 2 weeks) or standard single-agent therapy (methotrexate, docetaxel, or cetuximab).
- Disease progression within 6 months of platinum-based chemotherapy was a key inclusion criterion.
Main Results:
- Nivolumab demonstrated significantly longer median overall survival (7.5 months vs. 5.1 months; hazard ratio [HR] 0.70; P=0.01).
- The 1-year survival rate was substantially higher with nivolumab (36.0% vs. 16.6%).
- While median progression-free survival was similar (2.0 months vs. 2.3 months; HR 0.89; P=0.32), the 6-month PFS rate was higher with nivolumab (19.7% vs. 9.9%). The objective response rate was also higher with nivolumab (13.3% vs. 5.8%).
- Grade 3 or 4 treatment-related adverse events were less frequent with nivolumab (13.1% vs. 35.1%).
- Patient-reported physical, role, and social functioning remained stable with nivolumab, unlike standard therapy.
Conclusions:
- Nivolumab significantly improves overall survival in patients with platinum-refractory recurrent or metastatic squamous-cell carcinoma of the head and neck.
- Nivolumab offers a more favorable safety profile and better quality of life compared to standard single-agent therapies.
- The study supports nivolumab as a valuable treatment option for this patient population.
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