A phase 2 study of CBDCA + PEM + pembrolizumab in elderly (≥75 yrs) patients with advanced non-Sq, NSCLC.

Abstract

e20616 Background: Efficacy and safety of chemo-immunotherapy in elderly (≥ 75 years) patients with advanced non-Squamous (Sq), non-small cell lung cancer (NSCLC) has not been fully elucidated. Methods: This is a multi-centered, single arm, phase 2 study. Elderly (≥75 yrs) patients with advanced non-Sq, NSCLC were enrolled. Patients should be chemotherapy-naïve, ECOG performance status (PS) of 0-1, and those with driver mutation were excluded. Participants were treated with carboplatin (CBDCA, AUC = 5) + pemetrexed (PEM) 500mg/m2 + Pembrolizumab (Pembro) 200mg/body for four cycles followed by maintenance treatment with PEM + Pembro up to two years. The primary endpoint was overall response rate (ORR), and secondary endpoints consisted of progression-free survival (PFS), overall survival (OS), and safety (jRCTs051190095). Results: Between Apr, 2020 to May 2023, 20 patients were enrolled. The median age was 79 (range, 75-84), predominantly male (70%), smokers (65%), ECOG PS of 1 (95%), and adenocarcinoma (90%). Regarding PD-L1 expression of the tumor, 6 (30%) were PD-L1 ≥50%, 8 (40%) were 1-49%, and 6 (30%) <1%, respectively. The primary endpoint, ORR was 60.0% (95% confidence interval [CI] 39.4-78.3%). Median PFS was 8.7 months (95%CI: 4.8-15.5), and PFS rate at one and two years were 30.0% and 20.0%, respectively. Median PFS according to PD-L1 expression level were 8.95 months in PD-L1 ≥ 50%, 20.3 months in PD-L1 1-49%, and 2.1 months in PD-L1 < 1%, respectively. Median OS was not reached, and OS rate at one and two years were 84.4% and 70.9%, respectively. Severe adverse events were mostly hematological toxicities, and three pneumonitis, and two febrile neutropenia occurred. There was no treatment-related death. At the time of the analysis, 16 patients discontinued treatment: 12 disease progression, three adverse events, and one physician’s discretion. Conclusions: In elderly (≥75 yrs) patients with advanced non-Sq, NSCLC, CBDCA+PEM+Pembro was effective and tolerable. Clinical trial information: jRCTs051190095 .