“An extended duration of response could be seen in both PD-L1-positive and PD-L1-negative patients,” Lee said. “In the treatment-naïve cohort, prolonged stable disease could also be seen in PD-L1-positive patients who remained still on therapy at 12 months. In the previously treated patients, 6 of 18 patients remain on treatment, with 1 patient having a duration of response >8 months.”
Twenty-eight of 30 patients experienced tumor shrinkage, and Lee said there was a tendency for greater tumor shrinkage in the treatment-naïve patients. Tumor shrinkage was observed in both PD-L1-positive and PD-L1-negative patients, with no clear association between changes in tumor size and PD-L1 staining status.
Treatment-emergent adverse events (TRAEs) led to lenvatinib dose reductions in 18 patients. Five patients (17%) discontinued at least 1 study drug.
The most common TRAEs of any grade were diarrhea (83%), fatigue (70%), hypothyroidism (67%), stomatitis (60%), hypertension (57%), and nausea (57%). No new safety signals were found. The 2 grade-5 TRAEs were related to disease progression and not considered related to the study drugs.
Lee C, Makker V, Rasco D, et al. A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with renal cell carcinoma. Presented at ESMO 2017 Congress; September 8-12, 2017; Madrid, Spain. Abstract 847O.
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