2023 World Conference on Lung Cancer (Posters)-P2.14. First-Line Envafolimab plus Carboplatin-etoposide in Extensive-Stage Small-Cell Lung Cancer: a Single-Arm Phase II Study

P2.14. First-Line Envafolimab plus Carboplatin-etoposide in Extensive-Stage Small-Cell Lung Cancer: a Single-Arm Phase II Study - PDF(Slides)

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A phase II study in China investigated the efficacy and safety of envafolimab, an anti-PD-L1 immunotherapy, in combination with carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC). The study enrolled 32 treatment-naïve patients with ES-SCLC. Patients received four cycles of carboplatin and etoposide with envafolimab, followed by maintenance therapy with envafolimab until disease progression or intolerable toxicity.<br /><br />The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The median follow-up duration was 10.6 months. The study reported an ORR of 84.4% and a DCR of 96.9%. The median PFS was 6.2 months. The median OS was not mature, with 6-month, 9-month, and 12-month OS rates of 87.3%, 76.7%, and 71.9% respectively.<br /><br />The study also evaluated the safety profile of the treatment combination. The majority of treatment-emergent adverse events (TEAEs) were grade 1-2, and the most common TEAEs included anemia, decreased white blood cell count, hypothyroidism, hypokalemia, and increased liver enzymes. The study reported immune-related adverse events, such as hypothyroidism and hyperthyroidism, in a subset of patients.<br /><br />In conclusion, the study demonstrated that the combination of envafolimab with carboplatin and etoposide showed significant efficacy and manageable toxicities as first-line treatment for ES-SCLC. These findings support further confirmation through larger prospective clinical trials. Envafolimab has been approved for the treatment of microsatellite instability-high or deficient mismatch repair advanced solid tumors in China.

Asset Subtitle

Shengjie Sun

Meta Tag

Speaker Shengjie Sun

Topic SCLC & Neuroendocrine Tumors: First Line Therapy

Keywords

phase II study

China

efficacy

safety

envafolimab

carboplatin

etoposide

extensive-stage small-cell lung cancer

treatment-naïve patients

progression-free survival