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LEAP-010

Pembrolizumab with or without lenvatinib as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma

Phase 3N = 511NCT04199104

Population
PD-L1 CPS 1 or more recurrent or metastatic head and neck squamous cell carcinoma, first line
Design
Randomised (1:1), placebo-controlled, double-blind phase 3 study in participants aged 18 years or older with PD-L1 combined positive score (CPS) 1 or more recurrent or metastatic head and neck squamous cell carcinoma deemed incurable by local therapy. Lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously every 3 weeks, or placebo plus pembrolizumab, for up to 35 cycles. Primary endpoints were objective response rate, progression-free survival and overall survival; ORR and PFS were reported from the first interim analysis (data cut-off 6 July 2022) and OS from the second (data cut-off 30 May 2023).
Primary endpoint
ORR, PFS, OS
Arms
  • Lenvatinib plus pembrolizumab (experimental, n = 256): Lenvatinib 20 mg daily plus pembrolizumab 200 mg every 3 weeks (up to 35 cycles)
  • Placebo plus pembrolizumab (control, n = 255): Placebo daily plus pembrolizumab 200 mg every 3 weeks (up to 35 cycles)
People
Licitra L, LEAP-010 investigators
PFSHR 0.64 (95% CI 0.50–0.81)Δ median PFS+3.4 monthsΔ ORR+20.7 pointsOSHR 1.15 (95% CI 0.91–1.45)Δ median OS−2.9 months
Show the numbers
Results reported for LEAP-010
EndpointAnalysisLenvatinib plus pembrolizumabPlacebo plus pembrolizumabEffect
PFSParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 2026median 6.2 monthsmedian 2.8 monthsHR 0.64 (95% CI 0.50–0.81)P=0.0001040First interim analysis; median time from random assignment to data cut-off 11.5 months.
ORRParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 202646.1%25.4%P=0.0000251First interim analysis. Difference in ORR 20.2 percentage points (95% CI 10.5 to 29.6).
OSParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 2026median 15 monthsmedian 17.9 monthsHR 1.15 (95% CI 0.91–1.45)P=0.882Second interim analysis; median time from random assignment to data cut-off 21.3 months. The abstract concludes lenvatinib plus pembrolizumab improved ORR and PFS but not OS.
Results reported for LEAP-010
EndpointAnalysisLenvatinib plus pembrolizumabPlacebo plus pembrolizumabEffect
PFSParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 2026median 6.2 monthsmedian 2.8 monthsHR 0.64 (95% CI 0.50–0.81)P=0.0001040First interim analysis; median time from random assignment to data cut-off 11.5 months.
ORRParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 202646.1%25.4%P=0.0000251First interim analysis. Difference in ORR 20.2 percentage points (95% CI 10.5 to 29.6).
OSParticipants with PD-L1 CPS 1 or more (the abstract does not state the analysis population)interimLicitra 2026median 15 monthsmedian 17.9 monthsHR 1.15 (95% CI 0.91–1.45)P=0.882Second interim analysis; median time from random assignment to data cut-off 21.3 months. The abstract concludes lenvatinib plus pembrolizumab improved ORR and PFS but not OS.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.640.5–0.81
OS1.150.91–1.45
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%02468101214Months (modelled)
  • Lenvatinib plus pembrolizumab (experimental)
  • Placebo plus pembrolizumab (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLenvatinib plus pembrolizumabPlacebo plus pembrolizumab
0100.0%100.0%
463.9%37.1%
840.9%13.8%
1226.1%5.1%
1616.7%1.9%
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%010203040Months (modelled)
  • Lenvatinib plus pembrolizumab (experimental)
  • Placebo plus pembrolizumab (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLenvatinib plus pembrolizumabPlacebo plus pembrolizumab
0100.0%100.0%
1160.2%65.3%
2236.2%42.7%
3420.8%26.8%
4512.5%17.5%
Primary publication: Licitra L, Tahara M, Harrington K, Olivera Hurtado de Mendoza M, Guo Y, Aksoy S, et al. Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study. J Clin Oncol. 2026;44(12):1098-1107. PubMedDOI

Appears in

Sources

  1. Licitra L, Tahara M, Harrington K, Olivera Hurtado de Mendoza M, Guo Y, Aksoy S, et al. Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study. J Clin Oncol. 2026;44(12):1098-1107.

    PubMedDOI