FDA grants breakthrough therapy designation to JNJ-6372 in non-small cell lung cancer


NSCLC patients with EGFR exon 20 insertion mutations are generally insensitive to EGFR TKI treatments and have a worse outcome compared to patients with sensitizing mutations (EGFR exon 19 deletions/ L858R mutation). Currently, there are no FDA-approved targeted therapy in this group of patients.

JNJ-6372 is a novel bispecific antibody that targetes EGFR and MET mutations and amplifications and is believed to have the potential to benefit patients with EGFR exon 20 insertion mutations. The Breakthrough Therapy Designation is based on the data from a Phase 1 study. The results showed that among 99 evaluable patients, the response rate was 28%. In patients who had EGFR exon 20 insertion mutations, 6 patients had partial response. The treatment was also found to have a manageable safety profile. This preliminary data suggests that JNJ-6372 could be a potential treatment for NSCLC patietns with EGFR ex 20 insertion mutations in the future.

J Clin Oncol. 2019;37(suppl 15; abstr 9009).