According to results from a phase 3 study, the addition of low-dose nivolumab to triple metronomic chemotherapy significantly improved overall survival (OS) among patients with relapsed, recurrent, or newly diagnosed advanced head and neck squamous cell carcinoma. 

These data were presented by Vijay Maruti Patil, MD, MBBS, P.D. Hinduja Hospital, Mumbai, India, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

While the benefit of adding nivolumab to metronomic chemotherapy has been shown previously, study authors noted, “whether it demonstrates sustained benefit over the long term is unknown.” In this open-label study, patients with relapsed, recurrent, or newly diagnosed advanced head and neck squamous cell carcinoma were randomized on a 1-to-1 basis to receive oral metronomic chemotherapy (9 mg/m² methotrexate, 200 mg of celecoxib, and 150 mg of erlotinib) with or without 20 mg of intravenous nivolumab once every 3 weeks until disease progression or unacceptable toxicity. In the intention-to-treat analyses, there were 75 patients included in the chemotherapy arm and 76 patients in the chemotherapy plus nivolumab arm. The primary end point was OS. 

At a median follow-up of 32.5 months, 1-year OS was 20% in the chemotherapy arm and 35.5% in the chemotherapy plus nivolumab arm (hazard ratio [HR], 0.653; 95% confidence interval [CI], 0.447 to 0.956; P = .028), 2-year OS was 5.3% and 18.4% respectively (HR, 0.632; 95% CI, 0.448 to 0.892; P = .009), and 2.5-year OS was 5.3% and 17.1% respectively (HR, 0.638; 95% CI, 0.452 to 0.899; P = .01). The benefit of nivolumab to OS were found to be independent of factors such as age, gender, ECOG performance status, site of malignancy, time-to-failure, PDL1 score, and previously exposure to platinum therapy.

Dr Patil et al concluded, “The addition of low-dose nivolumab to triple metronomic chemotherapy leads to a tripling of OS thus suggesting that even low-dose nivolumab has sustainable benefits.” 

Source: 

Patil VM, Noronha V, Menon NS, et al. Long term results of phase 3 randomized study evaluating the addition of low dose nivolumab to palliative chemotherapy in head and neck cancer. Presented at the ASCO Annual Meeting. May 31-June 4, 2024; Chicago, IL. Abstract #LBA6054