MUMBAI — A phase 3 trial of ultra-low-dose nivolumab combined with chemotherapy for advanced head and neck squamous cell carcinoma showed improved survival and fewer side effects, according to results presented at the American Society of Clinical Oncology annual meeting on May 31, 2026. The study was conducted in India and led by Minit Jalan Shah of Tata Memorial Centre in Mumbai.
The trial enrolled 422 adults with advanced platinum-sensitive head and neck squamous cell carcinoma, the second most commonly diagnosed cancer in India. Participants were randomly assigned to receive either standard paclitaxel-carboplatin chemotherapy or triple-oral metronomic chemotherapy combined with ultra-low-dose nivolumab, known as TMC-I.
Patients receiving TMC-I had a median overall survival of 10.3 months, compared with 6.2 months for those receiving standard chemotherapy. About 46% of patients who received TMC-I were alive after one year, compared with 23% in the control group. The TMC-I regimen was also associated with fewer severe side effects, with rates of grade 3 or higher adverse events roughly 10 percentage points lower than in the standard chemotherapy group.
Ultra-low-dose nivolumab combined with triple-oral metronomic chemotherapy costs about $230 per month, a fraction of the tens of thousands of dollars per year that immune checkpoint inhibitors can cost in India. Less than 3% of eligible patients in India currently receive a checkpoint inhibitor for this cancer type. Based on the trial results and prior studies, TMC-I has become the preferred first-line regimen in India, according to Minit Jalan Shah.
Julie Gralow, ASCO’s chief medical officer and executive vice president, said the findings could have implications beyond India. “We could, thanks to a low-resource setting, potentially do the study needed for us to maybe more appropriately dose these drugs in high-resource settings.” She added that a head-to-head trial comparing standard-dose and low-dose immunotherapy would need to be conducted abroad but could have broad implications if it included a U.S. standard-of-care comparator arm.
“Health care costs in the United States and for the treatment of cancer are exceedingly high, and anything we could do to better understand the comparability across these 12 U.S. FDA-approved PD1/PDL1 inhibitors, the biomarkers that better select a smaller population who benefit, and the appropriate dosing, are incredibly appropriate and are in the best interest of our patients as well as our healthcare system.”