The Type II extension of indication application seeks approval for Rybrevant combo as a first-line treatment of NSCLC patients with activating EGFR exon 20 insertion mutations
Janssen is seeking EMA approval for Rybrevant combo in certain patients with NSCLC. (Credit: Julia Koblitz on Unsplash)
Janssen Pharmaceutical Companies of Johnson & Johnson has filed an application to the European Medicines Agency (EMA) for Rybrevant (amivantamab) in combination with chemotherapy to treat certain types of adult patients with advanced non-small cell lung cancer (NSCLC).
Rybrevant is a fully human epidermal growth factor receptor (EGFR)-MET bispecific antibody with immune cell-directing activity. It is designed to target tumours with activating and resistant EGFR mutations, MET mutations, and amplifications.
Janssen’s Type II extension of indication application seeks approval for the Rybrevant combo as the first-line treatment of NSCLC patients with activating EGFR exon 20 insertion mutations.
The application is backed by data from the Phase 3 PAPILLON clinical trial that assessed the safety and efficacy of amivantamab in combination with chemotherapy comprising carboplatin and pemetrexed.
According to Janssen, the study met its primary endpoint in the amivantamab/chemotherapy group. It significantly and clinically meaningfully improved progression-free survival (PFS) over chemotherapy alone in the patient population.
The safety profile of the combination was consistent with what has been observed with individual components.
Janssen Research & Development solid tumours clinical development VP Kiran Patel said: “PAPILLON is the first randomised Phase 3 study to read out in patients with NSCLC with EGFR exon 20 insertion mutations.
“Pending approval, this creates an opportunity to make a significant improvement to the standard of care for this patient population, where high unmet medical needs remain.
“We look forward to working with the EMA to bring this potential new indication to the lung cancer community as soon as possible.”
PAPILLON is an open-label trial with PFS as the primary endpoint. Key secondary endpoints included overall response rate (ORR), PFS after the first subsequent therapy, time to symptomatic progression, and overall survival (OS).
The EMA submission comes after a supplemental biologics license application (sBLA) was recently submitted to the US Food and Drug Administration (FDA).