Real-World Time on Treatment with First-Line Pembrolizumab Monotherapy for Advanced NSCLC with PD-L1 Expression ≥...

Area of Science:

• Oncology
• Immunotherapy
• Lung Cancer Research

Background:

• First-line pembrolizumab monotherapy is approved for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50%.
• Real-world time on treatment (rwToT) is a valuable intermediate endpoint correlated with overall survival.
• Understanding rwToT in diverse patient populations, including those with varying performance status and KRAS mutation status, is crucial.

Purpose of the Study:

• To evaluate real-world time on treatment (rwToT) with first-line pembrolizumab monotherapy in advanced NSCLC.
• To analyze rwToT based on ECOG performance status (PS) and KRAS mutation status in a US real-world setting.
• To assess the correlation of rwToT with clinical trial data for pembrolizumab in advanced NSCLC.

Main Methods:

• Retrospective analysis of deidentified electronic medical record data from US oncology practices.
• Inclusion criteria: advanced NSCLC, ECOG PS 0-2, PD-L1 expression ≥ 50%, no EGFR/ALK/ROS1 alterations, initiated first-line pembrolizumab (Nov 2016–Mar 2020).
• Kaplan-Meier method used to estimate median rwToT; data cutoff March 2021; median follow-up 34 months.

Main Results:

• Median rwToT was 7.4 months for 807 patients with PS 0-1, consistent with KEYNOTE-024 trial (7.9 months).
• Median rwToT was significantly shorter (2.1 months) for 237 patients with PS 2.
• For PS 0-1 patients, median rwToT was 7.6 months for KRAS-mutated and 7.0 months for KRAS wild-type nonsquamous NSCLC.

Conclusions:

• First-line pembrolizumab monotherapy demonstrates a long-term benefit in real-world settings for advanced NSCLC with PD-L1 ≥ 50%.
• Patients with good performance status (PS 0-1) experience longer treatment durations.
• rwToT appears consistent across KRAS mutation statuses in patients with good performance status, suggesting broad applicability.