NEW YORK – Janssen Pharmaceutical Companies, a unit of Johnson & Johnson, said on Tuesday that its investigational drug JNJ-61186372 (JNJ-6372) has been granted breakthrough therapy designation by the US Food and Drug Administration. The drug is being evaluated in non-small cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. There are no approved drugs yet for EGFR exon 20-mutated NSCLC.
JNJ-6372 is a bispecific EGFR-MET antibody that the company believes "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, global therapeutic area head, oncology at Janssen said in a statement.
The breakthrough therapy designation comes after the preliminary data from a Phase I trial showed that the drug had activity in patients and appeared to be well tolerated. The study evaluated the effects of JNJ-6372 in combination with lazertinib, a novel third-generation tyrosine kinase inhibitor licensed by Janssen from South Korean pharma company Yuhan, in adult patients with advanced NSCLC.
Once Phase I wraps up, investigators will use the recommended dose determined  to proceed to Phase II. Enrollment into the Phase II expansion cohort will be ongoing, and researchers will aim to monitor the drug's activity as a monotherapy for multiple subpopulations of NSCLC patients, such as those with a C797S resistance mutation or MET amplification.Â