JNJ-64041757 (JNJ-757), a Live, Attenuated, Double-Deleted Listeria monocytogenes-Based Immunotherapy in Patients With NSCLC: Results From Two Phase 1 Studies.

ABSTRACT:

Introduction

JNJ-64041757 (JNJ-757) is a live, attenuated, double-deleted Listeria monocytogenes-based immunotherapy expressing human mesothelin. JNJ-757 was evaluated in patients with advanced NSCLC as monotherapy (phase 1) and in combination with nivolumab (phase 1b/2).

Methods

Patients with stage IIIB/IV NSCLC who had received previous therapy were treated with JNJ-757 (1 × 10⁸ or 1 × 10⁹ colony-forming units [CFUs]) alone (NCT02592967) or JNJ-757 (1 × 10⁹ CFU) plus intravenous nivolumab 240 mg (NCT03371381). Study objectives included the assessment of immunogenicity, safety, and efficacy.

Results

In the monotherapy study, 18 patients (median age 63.5 y; women 61%) were treated with JNJ-757 (1 × 10⁸ or 1 × 10⁹

SUBMITTER: Brahmer JR 

PROVIDER: S-EPMC8474274 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature