The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JNJ-6372 (Janssen) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets activating and resistant EGFR and MET mutations and amplifications. 

The designation is supported by data from a multicenter, open-label, first-in-human, dose-escalation phase 1 study that assessed the preliminary efficacy, safety, and pharmacokinetics of JNJ-6372 as monotherapy and in combination with lazertinib, a novel 3rd-generation EGFR tyrosine kinase inhibitor, in adult patients with advanced NSCLC. The purpose of the study is to determine the recommended phase 2 dose of JNJ-6372. The Company is currently enrolling patients into the part 2 dose expansion cohort.

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“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,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “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.”


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For more information visit janssen.com.

This article originally appeared on MPR