Nivolumab improved overall survival compared with single-agent investigator’s choice of chemotherapy in patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), a study presented at the American Academy for Cancer Research (AACR) Annual Meeting 2016 has shown.1
“Recurrent or metastatic head and neck squamous cell carcinoma that is not responsive to platinum-based chemotherapy progresses very rapidly, and patients have a very poor prognosis,” said Maura L. Gillison, MD, PhD, a professor in the Department of Internal Medicine at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Treatment usually involves single-agent chemotherapy. However, no therapy has been shown to improve survival for this patient population. New treatment options are desperately needed.”
Nivolumab is a fully human IgG4 anti-programmed death-1 (PD-1) monoclonal antibody that is indicated for the treatment of advanced renal cell carcinoma, unresectable or metastatic melanoma, and metastatic non-small cell lung cancer. Because patients with platinum-refractory recurrent or metastatic HNSCC have a poor prognosis and no chemotherapy options to prolong survival, researchers sought to evaluate the impact of nivolumab on overall survival in this patient population.
For the phase 3 CheckMate-141 trial, researchers enrolled 240 patients with recurrent or metastatic HNSCC who progressed within 6 months of platinum-based chemotherapy. Participants were randomly assigned 2:1 to receive nivolumab 3 mg/kg IV every 2 weeks or single-agent investigator’s choice of chemotherapy weekly (methotrexate 40-60 mg/m2, docetaxel 30-40 mg/m2, or cetuximab 400-mg/m2 loading dose followed by 250 mg/m2 weekly). Patients in the immunotherapy arm were eligible to receive nivolumab beyond disease progression if there was evidence of clinical benefit.
Results showed that median overall survival was 7.5 months (95% CI, 5.5-9.1) with nivolumab compared with 5.1 months (95% CI, 4.0-6.0) for chemotherapy (HR, 0.70; 97.73% CI, 0.51-0.96; P=.010). The 12-month overall survival rate was 36% with nivolumab and 17% with investigator’s choice.
Median progression-free survival was 2.0 months (95% CI, 1.9-2.1) and 2.4 months (95% CI, 2.0-3.1), respectively (P=.303). The objective response rate was 11.7% with nivolumab vs 7.4% with chemotherapy.
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Researchers also observed a similar effect on overall survival with nivolumab for both patients with human papillomavirus (HPV)-positive cancer and those with HPV-negative disease. Among patients with HPV-positive HNSCC, median overall survival was 9.1 months for nivolumab vs 4.4 months for investigator’s choice. Patients with HPV-negative disease who received nivolumab had a median overall survival of 7.5 months vs 5.8 months for those given investigator’s choice.
“This study is the first randomized clinical trial to clearly demonstrate improved overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma,” Dr Gillison said. “We hope that the results will establish nivolumab as a new standard of care option for this patient population and thereby fulfill a huge unmet need.”
- Gillison M, Blumenschein G, Fayette J, et al. Nivolumab (nivo) vs investigator’s choice (IC) for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): CheckMate-141. Oral presentation at: AACR Annual Meeting 2016; April 16-20, 2016; New Orleans, LA.