Tislelizumab Approval Status for Head and Neck Cancers
Yes, tislelizumab is approved and strongly recommended for head and neck cancers, specifically for recurrent or metastatic nasopharyngeal carcinoma as first-line treatment in combination with gemcitabine and cisplatin. 1
Approved Indication
Tislelizumab, combined with gemcitabine and cisplatin, should be offered as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (evidence quality: high; strength of recommendation: strong). 1, 2
Key Clinical Details:
- Dosing regimen: 200 mg intravenously every 3 weeks for 4-6 cycles in combination with chemotherapy, followed by tislelizumab maintenance until disease progression (up to 2 years). 2, 3
- Chemotherapy backbone: Gemcitabine 1,000 mg/m² on days 1 and 8, plus cisplatin 80 mg/m² on day 1, every 21 days. 2
- PD-L1 testing not required: Clinical benefit is observed regardless of PD-L1 expression status. 2
Evidence Supporting Use
The recommendation is based on high-quality evidence demonstrating:
- Progression-free survival: 11.7 months with tislelizumab plus chemotherapy versus 8.0 months with chemotherapy alone (HR 0.52,95% CI 0.36-0.74). 2
- Overall survival benefit: 40% reduction in risk of death (HR 0.603,95% CI 0.364-0.997), with median OS not reached in the tislelizumab arm versus 33.7 months with placebo. 2
- Efficacy independent of PD-L1 status: Benefit demonstrated in both PD-L1-negative and PD-L1-positive subgroups. 2
Alternative Options
If tislelizumab is unavailable, pembrolizumab or nivolumab may be offered with gemcitabine and cisplatin, though this carries a lower evidence quality and weaker recommendation. 1, 2
Other Head and Neck Cancer Subtypes
For non-nasopharyngeal head and neck squamous cell carcinoma (HNSCC), tislelizumab is not specifically mentioned in current ASCO guidelines. The preferred agents for recurrent or metastatic HNSCC are:
- Pembrolizumab (monotherapy or with platinum/fluorouracil) for CPS ≥ 1. 1
- Nivolumab for platinum-refractory disease. 1
Real-world data from 39 patients with HNSCC or nasopharyngeal carcinoma treated with tislelizumab showed promising efficacy (ORR 86.7% in neoadjuvant setting, 60% in salvage therapy) with acceptable tolerability. 4 However, this does not constitute regulatory approval for non-nasopharyngeal HNSCC.
Safety Profile
Tislelizumab demonstrates an acceptable safety profile with most adverse events ≤ grade 2, though grade 4 enteritis has been reported. 4 Common adverse effects include fatigue, anemia, and decreased neutrophil count. 5