Safety and Efficacy of Lenvatinib + Pembrolizumab in Patients with Ovarian Cancer: LEAP-005

2020 Year in Review - Ovarian Cancer —January 20, 2021

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Ovarian Cancer

The combination of lenvatinib + pembrolizumab exhibited a manageable safety profile and encouraging efficacy in patients with heavily pretreated ovarian cancer, as well as those with a previous history of treatment failure.

Clinical outcomes of trials investigating lenvatinib in combination with pembrolizumab in patients with ovarian cancer were assessed by Antonio González-Martín and colleagues as part of the ongoing, open-label, multicohort phase 2 LEAP-005 study, presented at the European Society of Gynaecological Oncology 2020 Virtual Conference.

In a previous phase 1b/2 trial across several cancer types, lenvatinib, an antiangiogenic multiple receptor tyrosine kinase inhibitor, plus pembrolizumab, a programmed cell death 1 immune checkpoint inhibitor, demonstrated promising clinical benefits.

This study evaluated clinical outcomes with lenvatinib + pembrolizumab in patients with ovarian cancer. Enrolled in the study were female patients aged ≥18 years with metastatic or unresectable ovarian cancer, Eastern Cooperative Oncology Group performance status 0 to 1, and 3 prior lines of therapy and measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1. Participants were treated with daily lenvatinib 20 mg in addition to intravenous pembrolizumab 200 mg every 3 weeks for 35 cycles, or until unacceptable toxicity or confirmed disease progression. Safety and objective response rate (ORR) were primary end points. Secondary end points included duration of response, disease control rate (DCR), and progression-free survival (PFS).

At least 1 dose of lenvatinib + pembrolizumab was administered to 31 patients with ovarian cancer; these patients had a median age of 62 years (range, 40-76 years). As of April 10, 2020, the median study follow-up was 7.8 months (range, 4.6-12.4 months). The ORR was 32%; other favorable efficacy end points included a DCR of 74% and median PFS of 4.4 months. More than two-thirds (68%) of patients experienced grade 3 to grade 5 treatment-related adverse events. One treatment-related adverse event led to death.

The investigators concluded that the combination of lenvatinib + pembrolizumab exhibited a manageable safety profile and encouraging efficacy in patients with heavily pretreated ovarian cancer, as well as in patients with a previous history of platinum failure and those who had previously been exposed to bevacizumab.

Source: González-Martín A, et al. Int J Gynecol Cancer. 2020;30(4_suppl). Abstract 297.

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Last modified: January 20, 2021

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