FDA Grants Breakthrough Therapy Designation to JNJ-6372 for NSCLC

Janssen Pharmaceutical Companies recently announced the FDA granted breakthrough therapy designation to JNJ-61186372, an EGFR-MET bispecific antibody, for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 mutations.

The FDA granted breakthrough therapy designation to JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, according to a Janssen press release.

The breakthrough therapy designation for JNJ-6372, an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody, was approved for those whose disease has progressed on or after platinum-based therapy.

"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," Peter Lebowitz, MD, PhD, global therapeutic area head, Janssen Research & Development, LLC, said in a press release.

Data from the open-label, multicenter phase I trial supported the FDA’s breakthrough designation, in which the researchers examined the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy and in combination with lazertinib in adult patients with advanced NSCLC. The study aims to determine the recommended phase II dose.

NSCLC with EGFR exon 20 is typically insensitive to EGFR tyrosine kinase inhibitor (TKI) treatments, according to the press release. Enrollment in the phase II cohort is ongoing, with researchers hoping to evaluate JNJ-6372 monotherapy in a number of NSCLC sub-populations.

"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," said Lebowitz in a press release.

NSCLC makes up about 80%-85% of all lung cancer cases, making it the second most common cancer behind skin cancer. The EGFR mutation is present in roughly 10%-15% of patients, while the EGFR exon 20 insertion mutation is found much less frequently, accounting for at least 9% of EGFRmutations.

The FDA grants breakthrough designation to investigational medicine in the hopes of expediting the review process. The designation requires preliminary clinical evidence for the drug which hopes to treat a serious or life-threatening condition.


Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer [news release]. Raritan, New Jersey. Published March 10, 2020. 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. Accessed March 11, 2020.