Trial results for the Phase 2 study (NCT04428151) investigating lenvatinib in combination with pembrolizumab for recurrent/metastatic head and neck squamous cell carcinoma were posted on ClinicalTrials.gov on 2025-05-25. The study found that the combination arm had a median overall survival of 8.4 months, compared to 11.3 months for participants receiving standard chemotherapy.
Background
The LEAP-009 study (MK-7902-009/E7080-G000-228) investigated new treatments for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that had progressed after prior platinum therapy and immunotherapy. The study aimed to assess if the combination of lenvatinib and pembrolizumab could improve overall survival compared to standard chemotherapy.
Trial design
The Phase 2 LEAP-009 study (NCT04428151) enrolled 408 participants with recurrent or metastatic squamous cell carcinoma of the head and neck who had progressed after prior platinum therapy and immunotherapy. The trial compared lenvatinib plus pembrolizumab against standard chemotherapy (docetaxel, capecitabine, or paclitaxel). Key outcomes included Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), and Duration of Response (DOR).
Key results
The trial results compared the efficacy of lenvatinib plus pembrolizumab against standard of care (SOC) chemotherapy:
- Overall Survival (OS): Median OS was 8.4 months for the lenvatinib + pembrolizumab group vs. 11.3 months for SOC chemotherapy. The Hazard Ratio (HR) was 1.48 (95.0% CI: 1.11 to 1.97), with a p-value of 0.9963.
- Progression-Free Survival (PFS): Median PFS was 3.0 months for the lenvatinib + pembrolizumab group vs. 2.8 months for SOC chemotherapy. The HR was 0.97 (95.0% CI: 0.74 to 1.28), with a p-value of 0.4181.
- Objective Response Rate (ORR): ORR was 13.9% for the lenvatinib + pembrolizumab group vs. 20.4% for SOC chemotherapy. The difference was -6.5% (95.0% CI: -15.4 to 2.3), with a p-value of 0.9266219.
- Duration of Response (DOR): Median DOR was 4.1 months for the lenvatinib + pembrolizumab group vs. 5.9 months for SOC chemotherapy.
What this means
The LEAP-009 trial results indicate that the combination of lenvatinib and pembrolizumab did not demonstrate an improvement in overall survival, progression-free survival, or objective response rate compared to standard chemotherapy in participants with recurrent or metastatic head and neck squamous cell carcinoma. The median overall survival was numerically lower in the combination arm, and the statistical analyses for key outcomes did not show a significant benefit for the combination. These findings suggest this regimen may not be a superior treatment option for this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04428151, titled "Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)," were posted on 2025-05-25 on clinicaltrials.gov.