In Short

This phase Ib/II study evaluated the efficacy and safety of Lenvima combined with Halaven in the treatment of patients with advanced leiomyosarcoma and liposarcoma.

The results showed that Lenvima plus Halaven led to:

• 20% of patients who responded to this combination and their tumors shrunk
• The median time it took for the disease to progress was 8.56 months

The combination of Lenvima and Halaven was associated with promising efficacy and a manageable side effects in patients with advanced leiomyosarcoma and liposarcoma.

Purpose of the Study

Satisfactory treatment options for advanced leiomyosarcoma (LMS) and liposarcoma (LPS) are limited.

The LEADER study (NCT03526679) investigated the safety and efficacy of Lenvima plus Halaven.

The LEADER study is a multicenter phase Ib/II study for advanced leiomyosarcoma (LMS) and liposarcoma (LPS).

Results

Thirty patients were enrolled (LMS 21, LPS 9); the median age was 59.

One patient had to temporarily stop Lenvima due to grade 2 arthritis in the first cycle.

Four out of six patients had to decrease the dose of Lenvima to 14mg between cycles two and three.

The confirmed response rate to the combination was 20%.

The median time it took for the disease to progress under this treatment was 8.56 months.

Conclusions

Lenvima plus Halaven has a manageable safety profile and exhibits promising efficacy for treating advanced leiomyosarcoma (LMS) and liposarcoma (LPS).

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