OA14.05 5-Year Survival of Pembrolizumab Plus Chemotherapy for Metastatic NSCLC With PD-L1 Tumor Proportion Score <1%

Document Type

Conference Proceeding

Publication Date

11-1-2023

Publication Title

J Thorac Oncol

Abstract

Introduction: Pembrolizumab plus chemotherapy significantly improves OS and PFS in patients with previously untreated metastatic NSCLC without EGFR or ALK alterations irrespective of PD-L1 tumor proportion score (TPS). We present 5-year outcomes from a pooled analysis of phase 3 trials of pembrolizumab plus chemotherapy in patients with previously untreated metastatic NSCLC with PD-L1 TPS <1%. Methods: This pooled analysis included individual patient data from the KEYNOTE-189 global (NCT02578680; data cutoff March 8, 2022) and Japan extension (NCT03950674; data cutoff February 7, 2023) studies of metastatic nonsquamous NSCLC without EGFR or ALK alterations and the KEYNOTE-407 global (NCT02775435; data cutoff February 23, 2022) and China extension (NCT03875092; data cutoff February 10, 2023) studies of metastatic squamous NSCLC. In KEYNOTE-189, patients received pembrolizumab or placebo plus pemetrexed and cisplatin or carboplatin; in KEYNOTE-407, patients received pembrolizumab or placebo plus carboplatin and paclitaxel or nab-paclitaxel. PD-L1 expression was centrally assessed using PD-L1 IHC 22C3 pharmDX (Agilent Technologies, Carpinteria, CA). Tumor response was assessed per RECIST version 1.1 by blinded independent central review (BICR). Efficacy was evaluated in the intention-to-treat population and safety in the as-treated population. Analyses were performed post hoc and are descriptive only. Results: Among 442 patients with PD-L1 TPS <1% included in this analysis, 255 (57.7%) received pembrolizumab plus chemotherapy and 187 (42.3%) received chemotherapy alone. Baseline characteristics were similar across treatment groups except for tumor histology; 111 patients (43.5%) in the pembrolizumab plus chemotherapy group and 119 (63.6%) in the chemotherapy alone group had squamous tumors. Median time from randomization to data cutoff was 60.7 (range, 49.9‒72.0) months. OS, PFS, ORR, and PFS2 were improved with pembrolizumab plus chemotherapy versus chemotherapy alone (Table). Treatment-related AEs occurred in 245/254 patients (96.5%) in the pembrolizumab plus chemotherapy group and 175/186 (94.1%) in the chemotherapy alone group, including 150 (59.1%) and 114 (61.3%), respectively, with grade ≥3 AEs. Conclusions: After 5 years of follow-up, pembrolizumab plus chemotherapy provided clinically meaningful improvements in survival outcomes and durable long-term clinical benefit versus chemotherapy alone with manageable safety in metastatic NSCLC with PD-L1 TPS <1%. These results continue to support the use of pembrolizumab plus chemotherapy as a standard of care first-line therapy for metastatic NSCLC, including in tumors with PD-L1 TPS <1%. Keywords: pembrolizumab, NSCLC, PD-L1-negative [Formula presented]

Medical Subject Headings

Hematology

PubMed ID

Not assigned.

Volume

18

Issue

11

First Page

S77

Last Page

S78

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