A phase 3 trial showed that the TMC-I regimen significantly improved survival in patients with platinum-sensitive, advanced head and neck squamous cell carcinoma receiving first-line palliative treatment. Conducted at the Tata Memorial Centre in India, the study compared TMC-I—an oral combination of methotrexate, erlotinib, and celecoxib plus ultra-low-dose nivolumab—with standard paclitaxel-carboplatin chemotherapy in 422 patients.
Patients treated with TMC-I achieved a median overall survival of 10.3 months versus 6.2 months with standard therapy, reducing the risk of death by 43%. Progression-free survival improved from 2.7 to 5.5 months, while the objective response rate more than doubled to 53.4% compared with 24.1%.
TMC-I also showed lower rates of severe treatment-related side effects and very few serious immunotherapy-related toxicities. Quality of life remained similar between groups. Researchers noted that the regimen costs about $2,700 per year, making it a potentially affordable and scalable option for low- and middle-income countries.