FDA grants Breakthrough Therapy Designation for JNJ-6372 in NSCLC indication

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

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.

YOU MAY BE INTERESTED IN

The University of California, San Francisco and global oncology communities mourn the death of Felix Y. Feng, MD, a radiation oncologist and a leading figure in genitourinary cancer research. A professor of radiation oncology, urology and medicine, and vice chair of translational research at the UCSF Helen Diller Family Comprehensive Cancer Center, Feng died from cancer on Dec.10, 2024. He was 48.
The late Felix Feng, MD (center) with researchers Jonathan Chou, MD, PhD (left) and Lisa Chesner, PhD (right), in 2019.Photo by Noah BergerFelix Y. Feng, a genitourinary cancer research leader, died on Dec. 10, 2024. He was 48.This article is republished with permission by NRG Oncology.Dr. Feng was the former NRG Oncology Genitourinary Cancer Committee chair and an RTOG Foundation member. After years of dedicated and enthusiastic commitment to the NRG and previously the RTOG Genitourinary Cancer Committee, chairing or co-chairing 13 research protocols for NRG and RTOG, Dr. Feng was appointed committee chair in March 2018, following in the footsteps of Dr. Howard Sandler, his mentor. Dr. Feng was also a member of the RTOG Foundation Board of Directors.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login