Janssen seeks expanded USFDA approval for Rybrevant in combination with chemotherapy

“PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results. This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We look forward to working with the FDA through the RTOR pathway in pursuit of an approval for RYBREVANT plus chemotherapy as we simultaneously progress the development of this novel bispecific antibody in additional patient populations.”

Following Breakthrough Therapy Designation from the U.S. FDA in 2020, RYBREVANT received accelerated approval in 2021 as the first fully-human, bispecific antibody for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations. The sBLA submission for RYBREVANT is also intended to satisfy the regulatory requirements of the accelerated approval confirming the clinical benefit observed in the Phase 1 CHRYSALIS study. The sBLA is supported by data from the Phase 3 PAPILLON (NCT04538664) clinical trial, a randomized, open-label study evaluating the efficacy and safety of RYBREVANT in combination with chemotherapy as first-line treatment in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

In July, Janssen announced the PAPILLON study met its primary endpoint with a statistically significant and clinically meaningful improvement in PFS (as measured by BICR) in patients receiving RYBREVANT plus chemotherapy versus chemotherapy alone. The combination of RYBREVANT and chemotherapy demonstrated a safety profile consistent with the safety profiles of the individual components.