Headline: For the first time this century, a systemic therapy has moved the needle for high-risk resected head and neck squamous cell carcinoma (HNSCC).
The Study: The straightforwardly-named phase 3 NIVOPOSTOP trial randomized 666 evaluable patients with resected HNSCC receiving standard adjuvant chemoradiation for high-risk features (read: nodal extracapsular extension, involved margins, ≥4 pathologically involved nodes, and/or multifocal perineural invasion) to +/- the addition of nivolumab with each concurrent cisplatin cycle with an additional 6 months of maintenance nivo q4 weeks x 6. Chemoradiation was 66 Gy conventionally-fractionated with concurrent cisplatin 100mg/mg2 q3 weeks x 3. Overall survival analysis is premature, but disease-free survival at 3 years was 53% with chemoradiation alone versus 63% with the addition of nivo. Of note, there was no PD-L1 requirement for eligibility. Recall, though, the recent presentation of KEYNOTE-689, which showed improved EFS with perioperative pembro for resectable HNSCC. We’ll have to wait and see if either approach can improve OS.
TBL: The addition of nivolumab to standard chemoradiation for resected high-risk H&N SCC significantly improves disease control. | Bourhis, ASCO 2025
The Study: The straightforwardly-named phase 3 NIVOPOSTOP trial randomized 666 evaluable patients with resected HNSCC receiving standard adjuvant chemoradiation for high-risk features (read: nodal extracapsular extension, involved margins, ≥4 pathologically involved nodes, and/or multifocal perineural invasion) to +/- the addition of nivolumab with each concurrent cisplatin cycle with an additional 6 months of maintenance nivo q4 weeks x 6. Chemoradiation was 66 Gy conventionally-fractionated with concurrent cisplatin 100mg/mg2 q3 weeks x 3. Overall survival analysis is premature, but disease-free survival at 3 years was 53% with chemoradiation alone versus 63% with the addition of nivo. Of note, there was no PD-L1 requirement for eligibility. Recall, though, the recent presentation of KEYNOTE-689, which showed improved EFS with perioperative pembro for resectable HNSCC. We’ll have to wait and see if either approach can improve OS.
TBL: The addition of nivolumab to standard chemoradiation for resected high-risk H&N SCC significantly improves disease control. | Bourhis, ASCO 2025