Janssen's Bispecific Antibody JNJ-6372 Receives FDA Breakthrough Therapy Designation for EGFR Exon 20 Insertion-Mutant NSCLC

On the 11th, Janssen, a subsidiary of Johnson & Johnson, announced that the U.S. FDA has granted Breakthrough Therapy Designation to its bispecific therapy, JNJ-6372, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease has progressed during or after platinum-based chemotherapy. Currently, there are no FDA-approved targeted therapies for lung cancer patients with EGFR exon 20 insertion mutations.

Lung cancer is one of the leading causes of cancer-related deaths worldwide and in China. The most common driver mutations in non-small cell lung cancer (NSCLC) are alterations in the EGFR gene, which encodes a receptor tyrosine kinase that promotes cell growth and division. EGFR mutations are present in 10% to 15% of NSCLC patients overall and in 40% to 50% of Asian NSCLC patients.

Non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations is a disease generally insensitive to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy and carries a poorer prognosis compared with the more common EGFR mutation-positive NSCLC. The current standard of care for this NSCLC population is conventional cytotoxic chemotherapy.

JNJ-6372 is a bispecific antibody targeting EGFR and MET. It not only blocks ligand binding to EGFR and MET and promotes receptor degradation, but also triggers antibody-dependent cellular cytotoxicity (ADCC). This antibody was jointly developed by Janssen and Genmab, utilizing Genmab’s DuoBody technology platform.

Image source: 123RF

This Breakthrough Therapy Designation is supported by data from an open-label, multicenter Phase 1 clinical study. The study evaluated the safety, pharmacokinetics, and preliminary efficacy of JNJ-6372 as monotherapy and in combination with lazertinib for the treatment of adults with advanced non-small cell lung cancer (NSCLC). Lazertinib is an innovative third-generation EGFR tyrosine kinase inhibitor (TKI). The study aimed to determine the recommended Phase 2 dose for the treatment of patients with advanced NSCLC.

“JNJ-6372 is a novel bispecific antibody, and we believe it has the potential to benefit specific patients with non-small cell lung cancer (NSCLC) who typically do not respond to current oral EGFR-targeted therapies or immune checkpoint inhibitors due to exon 20 insertion mutations,” said Dr. Peter Lebowitz, Global Therapeutic Area Head of Oncology at Janssen. “This Breakthrough Therapy designation is an important milestone in our advancement of the clinical development of JNJ-6372, targeting lung cancer subtypes stratified by genetic characteristics.”

References:

[1] Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer. Retrieved March 10, 2020, from https://www.prnewswire.com/news-releases/janssen-announces-us-fda-breakthrough-therapy-designation-granted-for--jnj-6372-for-the-treatment-of-non-small-cell-lung-cancer-301020992.html

Original Title: Flash | Janssen’s Bispecific Antibody Receives FDA Breakthrough Therapy Designation for Treating Specific Lung Cancer Patients

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