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Giving about one-twentieth of the standard dose of nivolumab alongside cheap oral chemotherapy nearly tripled one-year survival in advanced head and neck cancer, showing that immunotherapy can be made affordable without losing its effect.
Open-label phase 3 randomising 151 patients with advanced head and neck squamous cell carcinoma being treated with palliative intent to triple oral metronomic chemotherapy with or without nivolumab 20 mg flat every 3 weeks. One-year overall survival was 43.4% (95% CI 30.8-55.3) with nivolumab versus 16.3% (8.0-27.4) without; median overall survival 10.1 versus 6.7 months (hazard ratio 0.545; 95% CI 0.362-0.820; P=0.0036); grade 3 or worse adverse events 46.1% versus 50%.
The dose is roughly 6% of the approved flat dose and the drug cost correspondingly small. The trial has become the reference case for dose-optimisation in immuno-oncology and for pragmatic trials in low- and middle-income countries.
For the majority of the world's head and neck cancer patients who cannot afford full-dose checkpoint inhibitors, a low dose added to oral metronomic chemotherapy is a tested alternative that improves survival. It also challenges the assumption that approved doses are the necessary doses: pharmacology had long suggested receptor saturation at far lower exposures.
Shares Vijay Patil, Kumar Prabhash, Tata Memorial Centre, Wrong doses.
Shares Vanita Noronha, Vijay Patil, Kumar Prabhash, Tata Memorial Centre.
Shares Vanita Noronha, Kumar Prabhash, Tata Memorial Centre, Prices and value.
Shares Wrong doses, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Nivolumab.
Shares Wrong doses, Prices and value, Nivolumab, Immune checkpoint inhibitors.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Nivolumab, Immune checkpoint inhibitors.
Shares Vijay Patil, Kumar Prabhash, Tata Memorial Centre, Nivolumab.
Shares Tata Memorial Centre, Wrong doses, Prices and value, Nivolumab.