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Poster session 20

1445P - A randomized phase III trial on Pembrolizumab Alone versUs pembrolizumab-chemotherapy in first LInE NSCLC (PAULIEN), results of the interim analysis

Date

21 Oct 2023

Session

Poster session 20

Topics

Cytotoxic Therapy;  Clinical Research;  Response Evaluation (RECIST Criteria);  Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Ilias Houda

Citation

Annals of Oncology (2023) 34 (suppl_2): S755-S851. 10.1016/S0923-7534(23)01943-9

Authors

I. Houda1, E.B. Ulas2, S.M..S. Hashemi3, A. Becker2, H.M..A. Daniels2, S. Tarasevych4, E. Looysen4, P. Kunst5, A. Moons-Pasic6, N. Thönissen7, J.M.W. van Haarst8, P. van Tilburg9, B. van der Maat10, N. Barlo11, M. Disselhorst12, V. van Diepen13, M. Tiemessen13, M. van Laren13, J. Veltman2, I. Bahce3

Author affiliations

  • 1 Pulmonary Medicine, Amsterdam University Medical Center, location VUmc, 1081HV - Amsterdam/NL
  • 2 Pulmonary Medicine, Amsterdam UMC - Vrije University Medical Centre (VUmc), 1081 HV - Amsterdam/NL
  • 3 Pulmonary Diseases, Amsterdam UMC - Vrije University Medical Centre (VUmc), 1081 HV - Amsterdam/NL
  • 4 Pulmonary Medicine, Zaans Medisch Centrum, 1502 DV - Zaandam/NL
  • 5 Pulmonary Medicine, OLVG Hospital, 1091 HA - Amsterdam/NL
  • 6 Pulmonary Medicine, OLVG - location West, 1061 AE - Amsterdam/NL
  • 7 Pulmonary Medicine, Bovenij Hospital, 1034 CS - Amsterdam/NL
  • 8 Pulmonary Medicine, Tergooi Ziekenhuizen, 1261 AN - Blaricum/NL
  • 9 Pulmonary Medicine, Tergooi Hospital - locatie Hilversum, 1213 XZ - Hilversum/NL
  • 10 Pulmonary Medicine, Flevo-Ziekenhuis, 1315 RA - Almere/NL
  • 11 Pulmonary Medicine, Noordwest Ziekenhuisgroep, 1815 - Alkmaar/NL
  • 12 Pulmonary Medicine, Noordwest Ziekenhuisgroep - Alkmaar, 1815 JD - Alkmaar/NL
  • 13 Pulmonary Medicine, Dijklander Hospital, 1624 NP - Hoorn/NL

Resources

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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.

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