Safety and preliminary immunogenicity of JNJ-64041809, a live-attenuated, double-deleted Listeria monocytogenes-based immunotherapy, in metastatic castration-resistant prostate cancer.

ABSTRACT:

Background

The safety and immunogenicity of JNJ-64041809 (JNJ-809), a live-attenuated, double-deleted Listeria monocytogenes (LADD Lm)-based immunotherapy targeting 4 relevant prostate cancer antigens, was evaluated in a phase 1 study in patients with metastatic castration-resistant prostate cancer (mCRPC).

Methods

Men with progressive mCRPC who had received ≥2 prior approved therapies were enrolled. Primary study objectives were to determine the recommended phase 2 dose (RP2D) and to evaluate the safety and immunogenicity of JNJ-809.

Results

A total of 26 patients received JNJ-809 (1 × 10⁸ CFU (n = 6); 1 × 10⁹ CFU (n = 20)). No dose-limiting toxicities were reported, and 1 × 10⁹ CFU was selected as the RP2D. The most common adverse ev

SUBMITTER: Drake CG 

PROVIDER: S-EPMC9184270 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature