ASCO 2025 | Evaluating fianlimab and cemiplimab in PD-L1+ recurrent/metastatic HNSCC
Danny Rischin, MD, Peter MacCallum Cancer Centre, Melbourne, Australia, describes the design of a Phase II trial (NCT06769698) of fianlimab plus cemiplimab versus cemiplimab plus placebo in patients with recurrent or metastatic PD-L1 expressing head and neck squamous cell carcinoma (HNSCC). The study includes HPV-positive and HPV-negative cohorts, with the primary endpoint of objective response rate. Secondary endpoints include progression-free survival, disease control rate, and safety. This trial aims to explore dual checkpoint blockade as a potential strategy to enhance clinical outcomes. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
In recurrent metastatic squamous cell carcinoma of the head and neck, the advent of the PD-1 inhibitors has improved outcomes and has become part of the standard of care. The response rate to single agent Pembrolizumab, or Nivolumab, is in the range of 20%, so there’s a huge need to improve the outcomes in this disease. And we know that in this disease, another checkpoint that’s overexpressed is LAG3 and then we now have drugs that can target LAG3...
In recurrent metastatic squamous cell carcinoma of the head and neck, the advent of the PD-1 inhibitors has improved outcomes and has become part of the standard of care. The response rate to single agent Pembrolizumab, or Nivolumab, is in the range of 20%, so there’s a huge need to improve the outcomes in this disease. And we know that in this disease, another checkpoint that’s overexpressed is LAG3 and then we now have drugs that can target LAG3. We know from melanoma experience the combination of an anti-PD-1 and an anti-LAG3 is superior to an anti-PD-1 alone. We have promising data with the combination in preliminary studies in head and neck cancer and now and that’s the rationale for testing it in a larger randomized study now.
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