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Bispecific Antibody Granted FDA Breakthrough Therapy Designation for Exon 20–Mutated NSCLC

By: Jocelyn Solis-Moreira, MS
Posted: Wednesday, March 18, 2020

On March 10, the U.S. Food and Drug Administration (FDA) approved Breakthrough Therapy designation for JNJ-6372 (JNJ-61186372) as a targeted therapy for patients with metastatic non–small cell lung cancer (NSCLC) who have EGFR Exon 20 insertion mutations and whose disease has progressed on or after platinum-based chemotherapy. JNJ-6372 is an EGFR-MET factor bispecific antibody with immune cell–directing activity intended to target activating and resistant EGFR and MET mutations and amplifications.

The Breakthrough Therapy designation was based on recent data from a phase I, open-label, multicenter study (ClinicalTrials.gov identifier NCT02609776). The study evaluated the safety, pharmacokinetics, and preliminary efficacy of JNJ-6372 monotherapy in combination with lazertinib in adult patients with advanced NSCLC. Phase I data will also be used to determine dosages for phase II treatment conditions, which will evaluate this agent’s monotherapy activity in multiple NSCLC subpopulations with genomic alterations such as C797S resistance mutation or MET amplification.

Currently, there are no FDA-approved targeted therapies for patients with NSCLC and EGFR Exon 20 insertion mutations. Standard treatment for this disease is cytotoxic chemotherapy.



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