Abstract 1445P
Background
To date, first-line pembrolizumab monotherapy (PEM) has not been compared to pembrolizumab + chemotherapy (PEM/CT) in metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥50%. However, the regimen that provides the highest response rate, crucial for when a tumor response is urgently needed, is unknown. Here, we report the interim results of the PAULIEN study (NTR 8896), aiming to identify the regimen (PEM or PEM/CT) with the highest response rate.
Methods
This open label, phase 3, multicenter trial aimed to randomize (1:1) 84 patients with untreated metastatic NSCLC with PD-L1 TPS ≥50% and a high tumor burden to receive PEM (200mg fixed, 3 or 6 weekly) or PEM (200mg fixed, 3 weekly) + platinum-based chemo-doublets with either pemetrexed or paclitaxel. Pemetrexed and PEM were continued as maintenance therapy. Patients in the PEM arm received CT after progressive disease. Stratification factors included age, performance status, T-stage and histology. Co-primary endpoints were objective response rate (ORR) and disease control rate (DCR) at week 6 and 12 per RECIST v1.1. Secondary endpoints included progression-free survival, overall survival and safety. A planned interim analysis was performed (data cut-off March 1st, 2023).
Results
50 patients were randomized to PEM (n=19) and PEM/CT (n=31). Baseline characteristics were well balanced between arms. 42 patients were radiologically evaluable of whom 17 patients received PEM and 25 patients PEM/CT. The PEM arm demonstrated an ORR at week 6 of 38% vs. 44% in the PEM/CT arm (p=0.68) and a DCR of 88% vs. 88% (p=1.0). At week 12, the PEM arm demonstrated an ORR of 74% vs. 68% in the PEM/CT arm (p=1.0) and a DCR of 93% vs. 91% (p=1.0), respectively. The incidence of grade 3-4 treatment-related adverse events was 28% (PEM) vs. 52% (PEM/CT). No treatment-related deaths occurred.
Conclusions
In this interim analysis, the tumor response rate with first-line PEM alone was comparable to that of PEM/CT in metastatic NSCLC patients with PD-L1 TPS ≥50%,. No new safety signals were observed. More data is needed to explore subgroups that may still benefit from adding chemo to PEM in this population.
Clinical trial identification
NTR8896.
Editorial acknowledgement
Legal entity responsible for the study
Department of Pulmonary Medicine, Amsterdam University Medical Centers, location VU Medical Center.
Funding
Paulien van Deutekom Foundation.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1422P - Comprehensive genomic profiling (CGP) changes management and improves survival in patients with advanced non-small cell lung cancer (aNSCLC)
Presenter: George Simon
Session: Poster session 20
1423P - Clinical impact of radiological diagnosis of lymphangitic carcinomatosis in patients with extensive non-small cell lung cancer treated with immunotherapy
Presenter: Anita Bolina
Session: Poster session 20
1424P - Outcome of thromboembolic events and its influence on survival time of advanced NSCLC patients receiving antiangiogenic therapy
Presenter: Wei-Fan Ou
Session: Poster session 20
1425P - Clinical utility of liquid biopsy for the early diagnosis of EGFR mutant advanced lung cancer in real-life setting (CLEAR)
Presenter: Rola El Sayed
Session: Poster session 20
1427P - Exploration of the value of leptomeningeal biopsy in diagnosing and treating non-small cell lung cancer with leptomeningeal metastasis
Presenter: Lin Cai
Session: Poster session 20
1428P - Clinical benefit of combination chemo-immunotherapy in first-line treatment for patients over the age of 65 or 75 with metastatic NSCLC
Presenter: Thierry Landre
Session: Poster session 20
1429P - Homologous recombination repair (HRR) gene mutation: A novel biomarker for precision genomics testing in advanced lung cancer
Presenter: Madhu Nagaraj
Session: Poster session 20
1430P - Excellent performance of a fast and fully-automated RNA based genefusion assay conducted on a large fusion positive non-small cell lung cancer cohort within a multicenter study
Presenter: Arndt Hartmann
Session: Poster session 20
1431P - The nNGM Preclinical Platform: Preclinical research to generate evidence for patients with non-small cell lung cancer harboring variants of unknown significance
Presenter: Martin Ziegler
Session: Poster session 20