The following is a summary of “A Single-Arm Phase Ib/II Study of Lenvatinib plus Eribulin in Advanced Liposarcoma and Leiomyosarcoma” published in the December 2022 issue of Oncology by Chen et al.
For advanced leiomyosarcoma and liposarcoma, there are a few good therapy choices. Lenvatinib and eribulin were tested for their effectiveness and safety in the LEADER trial (NCT03526679). Phase Ib/II multicenter study for advanced leiomyosarcoma or liposarcoma, called LEADER. With a beginning dose of 18 mg/day of lenvatinib and 1.1 mg/m2 of eribulin on Days 1 and 8 of every 21-day cycle, the phase Ib portion enrolled 6 patients to evaluate the dose-limiting toxicity (DLT) and recommended phase II dose (RP2D).
Patients from phase Ib were expected to be included in the phase II efficacy study, and the primary goal was an objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors 1.1. Translational analyses were based on the transcriptome data collected from the NanoString nCounter platform. The median age of the 30 patients enrolled was 59 (leiomyosarcoma 21, liposarcoma 9). In the first cycle, 1 patient who met DLT criteria developed arthritis of grade 2, requiring the temporary cessation of lenvatinib treatment. Between cycles 2 and 3, 4 out of 6 patients had to reduce their lenvatinib dose to 14 mg. A combination of 14 milligrams of lenvatinib daily and 1.1 mg2 of eribulin per square meter was found to be RP2D.
There was no statistically significant difference in ORR between phase Ib/II groups (P=0.23), and the confirmed ORR was 20%. The 95% CI for progression-free survival was 4.40 months to not attained, with a median value of 8.56 months. After therapy, translation studies revealed increased dendritic cells in the tumor microenvironment (TME). The combination of lenvatinib and eribulin shows promise in the treatment of advanced leiomyosarcoma and liposarcoma, and its side effects are tolerable.