Combination Therapy for Platinum-Resistant Ovarian Cancer: A Novel At-Home Regimen with Envafolimab, Lenvatinib, and Etoposide
Mené sur 21 patientes atteintes d'un cancer de l'ovaire résistant aux sels de platine et récidivant, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité d'un traitement combinant envafolimab, lenvatinib et étoposide
Background: Effective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death-ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.
Methods: This was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion, who were administrated with envafolimab subcutaneously on day 1, and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6–10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR) and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results: Of the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% [95% confidence interval (CI) 21.5-69.2%], and the DCR was 83.3% (95% CI 58.6-96.4%). The median PFS was 10.2 months [95% CI 5.6-not applicable (NA)] and the median OS was 21.3 months [95% CI 6.8-NA]. The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.
Conclusion: Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.
The Oncologist , résumé, 2025