Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study.
Combining an immune-activating drug with a targeted antibody shows promising response rates in difficult-to-treat head and neck cancer, warranting larger studies.
This phase 1b/2 study evaluated the combination of PD-1 inhibitor toripalimab with the EGFR antibody cetuximab in recurrent/metastatic head and neck squamous cell carcinoma across two cohorts. The combination showed promising efficacy with ORR of 60% in platinum-refractory patients and acceptable toxicity, supporting further investigation in a larger trial.
What the study was
- Study design
- Open-label multicenter phase 1b/2 trial
- Population
- Adults with platinum-refractory R/M HNSCC (Cohort A) or previously untreated PD-L1-positive R/M HNSCC (Cohort B)
- Sample size
- 88
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Signal Transduction and Targeted Therapy
Why it surfaced
Phase 1b/2 trial in Signal Transduct Target Ther showing promising ORR (60%) with toripalimab+cetuximab in platinum-refractory HNSCC. Relevant to immunotherapy topic; PD-L1 status as biomarker for benefit. Phase 1b/2 design limits to STANDARD; warrants monitoring for phase 3 follow-up.
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