Pembrolizumab with or without lenvatinib in first-line metastatic non-small cell lung cancer

The study included patients with a PD-L1 tumor proportion score of 1% or higher and no targetable mutations. Although lenvatinib was associated with longer progression-free survival and higher objective response rates, overall survival was not significantly improved compared with placebo (14.1 months vs. 16.4 months). Importantly, the use of lenvatinib was associated with a significant increase in toxicity, resulting in death in 5.2% of patients. Given the unfavorable benefit-risk ratio, concomitant lenvatinib is not recommended in this clinical setting.



Lenvatinib plus pembrolizumab demonstrated antitumor activity and an acceptable safety profile in patients with previously treated metastatic non-small cell lung cancer. We evaluated lenvatinib plus pembrolizumab versus placebo plus pembrolizumab as first-line treatment of patients with metastatic non-small cell lung cancer in the LEAP-007 study (NCT03829332/NCT04676412).


Patients with previously untreated stage IV non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and no treatable EGFR/ROS1/ALK aberrations , were randomly assigned in a 1:1 ratio to receive lenvatinib 20 mg once daily or placebo; all patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary endpoints were progression-free survival (RECIST version 1.1) and overall survival (OS). We report the results of a prespecified, nonbinding OS futility analysis conducted at the fourth independent Data and Safety Monitoring Committee (DMC) review (futility cutoff: one-way P < 0.4960).


623 patients were randomized. At a median follow-up of 15.9 months, the median overall survival (95% CI) was 14.1 (11.4-19.0) months in the lenvatinib plus pembrolizumab group compared with 14.1 (11.4-19.0) months in the lenvatinib plus pembrolizumab group. The median survival of the group was 16.4 (12.6-20.6) months. plus pembrolizumab (HR, 1.10 (95% CI, 0.87-1.39); P=0.79744 (futility criteria met)). Median progression-free survival (95% CI) was 6.6 (6.1-8.2) months and 4.2 (4.1-6.2) months (HR, 0.78 (95% CI, 0.64-0.95)). Grade 3-5 treatment-related adverse events were observed in 57.9% of patients (179/309) and 24.4% (76/312). The study was unblinded and lenvatinib and placebo were discontinued on the recommendation of the data monitoring committee.

in conclusion:

The combination of lenvatinib plus pembrolizumab did not demonstrate a favorable benefit-risk profile compared with placebo plus pembrolizumab. Pembrolizumab monotherapy remains an approved treatment option in many regions for first-line metastatic NSCLC with PD-L1 tumor proportion score ≥1% and unchanged EGFR/ALK.

Source: BioPress

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