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Lenvatinib plus pembrolizumab in participants with advanced or recurrent endometrial cancer: Study 309/KEYNOTE-775
Christian Marth1, Domenica Lorusso2, Mariusz Bidziński3
1Medical University of Innsbruck, Department for Gynecology and Obstetrics, Innsbruck, Austria; AGO, Innsbruck, Austria.
Summary
Lenvatinib plus pembrolizumab showed improved survival outcomes and anti-tumor activity compared to chemotherapy in advanced endometrial cancer patients who received prior platinum-based chemotherapy. This combination therapy offers a manageable safety profile and is a potential treatment option.
Area of Science:
- Oncology
- Clinical Trials
- Gynecologic Oncology
Background:
- Endometrial cancer (EC) is a common gynecologic malignancy.
- Platinum-based chemotherapy is a standard treatment for advanced or recurrent EC.
- The efficacy of lenvatinib plus pembrolizumab in specific EC subgroups requires further investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of lenvatinib plus pembrolizumab versus chemotherapy in patients with advanced/recurrent/metastatic EC.
- To specifically analyze outcomes in a subgroup of patients who received neoadjuvant, adjuvant, or neoadjuvant+adjuvant platinum-based chemotherapy prior to study enrollment.
Main Methods:
- Phase 3 Study 309/KEYNOTE-775 and ENGOT-en9/LEAP-001 enrolled patients with advanced/recurrent EC.
- Participants were randomized to lenvatinib plus pembrolizumab or chemotherapy.
- Overall survival (OS) and progression-free survival (PFS) were primary endpoints, assessed per RECIST v1.1.
Main Results:
- In Study 309/KEYNOTE-775 (n=300), lenvatinib+pembrolizumab improved median OS (17.4 vs 13.3 months) and PFS (7.2 vs 3.9 months) versus chemotherapy.
- In ENGOT-en9/LEAP-001 (n=121), lenvatinib+pembrolizumab also demonstrated improved median OS (35.4 vs 22.1 months) and PFS (15.0 vs 8.3 months) versus chemotherapy.
- Objective response rates were higher with lenvatinib+pembrolizumab in both trials; common adverse events included hypertension and hypothyroidism.
Conclusions:
- Lenvatinib plus pembrolizumab showed superior anti-tumor activity and favorable outcomes in advanced EC patients with prior platinum-based chemotherapy.
- The combination therapy exhibited a manageable safety profile.
- Lenvatinib plus pembrolizumab is a viable and effective treatment option for this patient subgroup.
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