2023 World Conference on Lung Cancer (Posters)-P2.06. The Safety and Efficacy of Durvalumab as 1st Line Therapy in Patients with Advanced NSCLC and ECOG PS of 2

P2.06. The Safety and Efficacy of Durvalumab as 1st Line Therapy in Patients with Advanced NSCLC and ECOG PS of 2 - PDF(Abstract)

Back to course

Pdf Summary

This study presents the results of a phase II trial evaluating the safety and efficacy of durvalumab as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group performance status (ECOG PS) of 2. Durvalumab is currently the only FDA-approved agent for patients with unresectable stage III NSCLC after chemoradiotherapy. However, there is limited data on the use of durvalumab in NSCLC patients with impaired PS.<br /><br />The trial enrolled 50 patients with an ECOG PS of 2, of whom 48 received durvalumab. The patients had a median age of 78.5 years and predominantly had adenocarcinoma histology. The primary endpoints of the study were overall survival (OS) and safety, measured by grade 3 treatment-related adverse events (TRAEs). Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), 12-month OS (OS12), and OS, PFS, and ORR based on PD-L1 expression status. Health-related quality of life (HRQL) outcomes were also assessed.<br /><br />The results showed a median OS of 6 months, with TRAEs grade 3 occurring in 23% of patients. The median PFS was 3 months, and the ORR was 26%. The OS12 was 31%. OS and PFS varied based on PD-L1 expression status, with higher expression associated with longer survival. The study also found that durvalumab was well-tolerated, with no significant change in patient-reported HRQL over the course of treatment.<br /><br />Overall, this study demonstrates that single-agent durvalumab is safe and effective as a first-line therapy in patients with advanced NSCLC and an ECOG PS of 2. The results suggest that durvalumab may provide an encouraging OS benefit in patients with PD-L1 positive tumors. This study represents the largest prospective dataset of durvalumab in NSCLC patients with an ECOG PS of 2.

Asset Subtitle

Khvaramze Shaverdashvili

Meta Tag

Speaker Khvaramze Shaverdashvili

Topic Metastatic NSCLC: Immunotherapy - Prospective

Keywords

durvalumab

non-small cell lung cancer

NSCLC

Eastern Cooperative Oncology Group

performance status

chemoradiotherapy

adenocarcinoma

overall survival

progression-free survival

PD-L1 expression