Janssen Pharmaceutical has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC).

The drug is for patients having epidermal growth factor receptor (EGFR) Exon 20 insertion mutations and who have progressed on or following platinum-based chemotherapy.

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JNJ-6372 is an EGFR-mesenchymal-epithelial transition factor (MET) bispecific antibody designed to act on activating and resistant EGFR and MET mutations and amplifications.

FDA is yet to approve a drug for lung cancer patients with EGFR Exon 20 insertion mutations.

Janssen Research & Development Oncology global therapeutic area head Peter Lebowitz said: “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.

“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.”

The FDA designation comes from results of an open-label, multi-centre Phase I clinical trial that assessed safety, pharmacokinetics and preliminary efficacy of JNJ-6372 as a monotherapy and also in combination with lazertinib.

Janssen licensed lazertinib, an EGFR TKI, from Yuhan Corporation in 2018.

The Phase I trial establishes the recommended Phase II dose in patients with advanced non-small cell lung cancer. Patient recruitment into part two dose-expansion cohorts is ongoing.

Currently, the trial is assessing the activity of JNJ-6372 as monotherapy in different NSCLC sub-populations with genomic alterations, including C797S resistance mutation or MET amplification.

In January, Janssen received extended approval from the European Commission (EC) for Erleada (apalutamide) combined with androgen deprivation therapy (ADT) to treat adults with metastatic hormone-sensitive prostate cancer (mHSPC).