- Adding motolimod to the EXTREME chemotherapy regimen (carboplatin/cisplatin, fluorouracil, and cetuximab) is associated with improved survival of patients with head and neck squamous cell carcinoma (HNSCC) with HPV-positive status or injection site reactions.
Why this matters
- Treatment with motolimod, a toll-like receptor 8 (TLR8) agonist, may stimulate innate and adaptive immunity and benefit certain patient subsets.
- In the overall intent-to-treat population, adding motolimod was associated with similar median PFS (6.1 vs 5.9 months; HR, 0.99; P=.47) and OS (13.5 vs 11.3 months; HR, 0.95; P=.40) compared with placebo.
- In HPV-positive patients, adding motolimod was associated with significantly improved PFS (7.8 vs 5.9 months; HR, 0.58; P=.046) and OS (15.2 vs 12.6 months; HR, 0.41; P=.03) compared with placebo.
- In patients with injection site reactions, adding motolimod was associated with significantly improved OS (18.7 vs 12.6 months; HR, 0.56; P=.02) compared with placebo.
- 195 patients with HNSCC receiving the EXTREME chemotherapy regimen (100 with added motolimod and 95 with added placebo) were analyzed for survival outcomes.
- Funding: VentiRx Pharmaceuticals.
- Retrospective analysis of HPV-positive patients.