FDA has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
Janssen Pharmaceutical Companies of Johnson & Johnson sponsors JNJ-61186372.
JNJ-6372 is an EGFR-mesenchymal epithelial transition factor bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications. Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations.
Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to EGFR tyrosine kinase inhibitor treatments and carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).
The current standard of care for this patient population is conventional cytotoxic chemotherapy.
The Breakthrough Therapy Designation is supported by data from a phase I, first-in-human, open-label, multicenter study (NCT02609776). The study evaluates the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy and in combination with lazertinib[1], a novel third-generation EGFR TKI, in adult patients with advanced NSCLC.
The study seeks to determine the recommended Phase 2 dose in patients with advanced NSCLC. Enrollment into the Part 2 dose expansion cohorts is ongoing, as the study evaluates JNJ-6372 monotherapy activity in multiple NSCLC sub-populations with genomic alterations such as those with C797S resistance mutation or MET amplification.
