The FDA granted JNJ-6372 Breakthrough Therapy Designation for the treatment of metastatic non-small cell lung cancer with EGFR mutations after disease progression on another line of therapy.

The investigational agent is a targeted EGFR-MET bispecific antibody. 

JNJ-6372 is intended to treat NSCLC patients with EGFR Exon 20 insertion mutations who have progressed on or after chemotherapy. 

“JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies," according to Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology at Janssen. "This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer.”

The manufacturer noted that there are currently no approved drugs specifically intended for targeting EGFR Exon 20 insertion mutations in NSCLC patients.

This designation was based on data from Phase 1 study designed to determine the safety, pharmocokentics, and preliminary efficacy findings. 

The trial also sought to determine a recommended dose for the currently enrolling Phase 2 clinical trial. In the Phase 1 trial, JNJ-6372 was administered as monotherapy and in combination with lazertinib, and EGFR TKI.

According to the manufacturer, NSCLC patients with Exon 20 insertion mutations are usually “insensitive” to EGFR TKI agents.

MD /alert staff