Real-world multicentre cohort of first-line pembrolizumab alone or in combination with platinum-based chemotherapy in non-small cell lung cancer PD-L1 ≥ 50%

Abstract

Introduction Pembrolizumab alone (IO-mono) or in combination with platinum-based chemotherapy (CT-IO) is first-line standard of care for advanced non-small cell lung cancer (NSCLC) patients with PD-L1 ≥ 50%. This retrospective multicentre study assessed real-world use and efficacy of both strategies. Methods Patients with advanced NSCLC PD-L1 ≥ 50% from eight hospitals who had received at least one cycle of IO-mono or CT-IO were included. Overall survival (OS) and real-word progression-free-survival were estimated using Kaplan–Meier methodology. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and 95% CIs, and a Cox model with inverse propensity treatment weighting was carried out. Results Among the 243 patients included, 141 (58%) received IO-mono and 102 (42%) CT-IO. Younger patients, those with symptomatic disease and brain metastases were more likely to be proposed CT-IO. With a median follow-up of 11.5 months (95% CI 10.4–13.3), median OS was not reached, but no difference was observed between groups (p = 0.51). Early deaths at 12 weeks were 11% (95% CI 4.6–16.9) and 15.2% (95% CI 9.0–20.9) in CT-IO and IO groups (p = 0.32). After adjustment for age, gender, performance status, histology, brain metastases, liver metastases and tobacco status, no statistically significant difference was found for OS between groups, neither in the multivariate adjusted model [HR 1.07 (95% CI 0.61–1.86), p = 0.8] nor in propensity adjusted analysis [HR 0.99 (95% CI 0.60–1.65), p = 0.99]. Male gender (HR 2.01, p = 0.01) and PS ≥ 2 (HR 3.28, p < 0.001) were found to be negative independent predictive factors for OS. Conclusion Younger patients, those with symptomatic disease and brain metastases were more likely to be proposed CT-IO. However, sparing the chemotherapy in first-line does not appear to impact survival outcomes, even regarding early deaths.

Three-Year Overall Survival of Patients With Advanced Non–Small-Cell Lung Cancers With ≥50% PD-L1 Expression Treated With First-Line Pembrolizumab Monotherapy in a Real-World Setting (ESCKEYP GFPC Study)

“…Several analyses of real-world data obtained from lessselected aNSCLCs [3][4][5][6][7] confirmed the findings of the Keynote 024 trial. A French nationwide study evaluated the efficacy of pembrolizumab monotherapy given to 845 patients, 20% with brain metastases at diagnosis and > 20% with ECOG PS = 2.…”

“…According to the findings of those 2 studies, ECOG PS ≥2 was an independent factor associated with poorer OS 3,4 . That observation was echoed in other reports 5–12 . The results of a prospective, observational study on 40 patients with ECOG PS = 2 or ≥75 years old, with ≥1% PD-L1 expression on their aNSCLC cells showed that median (95% CI) OS on first-line pembrolizumab lasted 11.6 (1.4–NR) months for patients with ECOG PS = 2 and 11.6 (7.4–18.1) months for the elderly 9 .…”

“…3,4 That observation was echoed in other reports. [5][6][7][8][9][10][11][12] The results of a prospective, observational study on 40 patients with ECOG PS = 2 or ≥ 75 years old, with ≥ 1% PD-L1 expression on their aNSCLC cells showed that median (95% CI) OS on first-line pembrolizumab lasted 11.6 (1.4-NR) months for patients with ECOG PS = 2 and 11.6 (7.4-18.1) months for the elderly. 9 However, long-term, real-world efficacy data for pembrolizumab in this indication are scarcer.…”

Beyond clinical trials: real-world impact of immunotherapy on NSCLC in Jordan

“…which included patients who received 1L IO, survived at least 6 months and had an ECOG PS of 0-1 showed a median OS of 19.6 months ( 16 ). Another retrospective study showed the survival was better for the NSCLC patients who were alive at 12 weeks after starting single agent pembrolizumab compared to the whole cohort; however, the median OS was not reached when the data was published ( 17 ). The frequency of death at 12 weeks was 11% for those who received single agent pembrolizumab and 15.2% for the pembrolizumab and chemotherapy combination group ( 17 ).…”

“…Another retrospective study showed the survival was better for the NSCLC patients who were alive at 12 weeks after starting single agent pembrolizumab compared to the whole cohort; however, the median OS was not reached when the data was published ( 17 ). The frequency of death at 12 weeks was 11% for those who received single agent pembrolizumab and 15.2% for the pembrolizumab and chemotherapy combination group ( 17 ). In our study, 21% of the patients died within 3 months of starting IO.…”