Vanita Noronha MD; ASCO 2026: Ultra-Low Dose Immunotherapy Extends Life with Metastatic Head and Neck Cancer at Low Cost for Patients in Low and Middle Income Countries
CHICAGO, USA—Although recurrent or metastatic head and neck cancers respond well to palliative chemotherapy with immune checkpoint inhibition, this approach may be un-affordable in low and middle income countries. But a randomized phase three trial from India reported a pragmatic solution at the 2026 Annual Meeting of the American Society of Clinical Oncology. Ultra-low doses of pembrolizumab immunotherapy along with “triple oral metronomic chemotherapy” were found to bring good palliation and longer survival according to Vanita Noronha MD, Professor of Medical Oncology, Tata Memorial Hospital, Mumbai, India, as she explained to Peter Goodwin.
Ultra-Low Dose Immunotherapy Extends Life with Metastatic Head and Neck Cancer at Low Cost for Patients in Low and Middle Income Countries
An interview with Vanita Noronha MD, Professor of Medical Oncology, Tata Memorial Hospital, Mumbai, India
CHICAGO, USA—Although recurrent or metastatic head and neck cancers respond well to palliative chemotherapy with immune checkpoint inhibition, this approach may be un-affordable in low and middle income countries. But a randomized phase three trial from India reported a pragmatic solution at the 2026 Annual Meeting of the American Society of Clinical Oncology.
Ultra-low doses of pembrolizumab immunotherapy along with “triple oral metronomic chemotherapy” were found to bring good palliation and longer survival according to Vanita Noronha MD, Professor of Medical Oncology, Tata Memorial Hospital, Mumbai, India, as she explained to Peter Goodwin.
AUDIO JOURNAL OF ONCOLOGY: Vanita Noronha MD
IN： “I’m here at the American Society of …
OUT:…..for the Audio Journal of Oncology. 8:31secs
SOURCE:
J Clin Oncol 44; ASCO ABSTRACT:LBA6007(2026)
https://ascopubs.org/doi/10.1200/JCO.2026.44.17_suppl.LBA6007
Ultra-low-dose immunotherapy plus oral metronomic chemotherapy versus paclitaxel-carboplatin in platinum-sensitive recurrent or metastatic head and neck squamous cell carcinoma: A randomized phase III trial.
ASCO Presenter: Minit Shah MD
Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
Background:
Standard first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) includes platinum-based chemotherapy (PBC) combined with pembrolizumab or cetuximab; however, these regimens remain inaccessible for many patients globally, particularly in resource-limited settings. Triple oral metronomic chemotherapy combined with ultra-low-dose immunotherapy (TMC-I) has demonstrated promising activity and tolerability in earlier studies. We conducted a randomized phase III trial comparing TMC-I with PBC (paclitaxel and carboplatin) in patients with R/M-HNSCC receiving first-line palliative therapy.
Methods:
In this open-label, multicenter, phase III trial conducted at two centers, 422 patients with R/M-HNSCC were randomized (1:1) to receive paclitaxel 175 mg/m² plus carboplatin AUC 6 every 3 weeks (Arm-A) or TMC-I (oral methotrexate 9 mg/m² weekly, celecoxib 200 mg twice daily, erlotinib 150 mg daily, and nivolumab 20 mg IV every 3 weeks) (Arm-B). Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and quality of life (QoL). The planned sample size of 422 patients (211 per arm) provided 80% power with a two-sided α of 0.05. The trial was registered with the Clinical Trials Registry–India (CTRI/2024/01/061661).
Results:
The median age was 49.5 years (IQR 42–58), 85.5% were male, 78.9% had oral tobacco use, 76.3% had oral cavity primaries, 25.6% had metastatic disease, and 30.6% had ECOG performance status 2. After a median follow-up of 10.8 months (95% CI 8.1–13.6) in Arm-A and 11.9 months (95% CI 10.3–13.4) in Arm-B, the primary endpoint of OS was significantly improved with TMC-I compared with PBC. Twelve-month OS was 46% versus 23%, and six-month OS was 69% versus 52% (p < 0.001). Median OS was 10.3 versus 6.2 months (HR 0.565, 95% CI 0.439–0.728; p < 0.001). Median PFS was 5.5 versus 2.7 months (HR 0.465, 95% CI 0.371–0.582; p < 0.001). ORR was higher with TMC-I than with PBC (53.4% vs 24.1%; p < 0.001), with fewer grade ≥3 adverse events (34.1% vs 46.4%; p = 0.010). No treatment-related deaths were observed, and patient-reported QoL was preserved with TMC-I.
Conclusion:
TMC-I significantly improved survival outcomes and response rates while reducing severe toxicity and preserving QoL compared with PBC. At approximately USD 230 per month, TMC-I represents a promising and cost-effective first-line treatment option for patients with R/M-HNSCC.
Vanita Noronha MD ASCO 2026 A J Oncology
September 8, 2026