Rybrevant(amivantamab) in combination with chemotherapy is submitted to EMA for the first-line treatment of advanced non-small cell lung cancer with EGFR exon 20 insertion mutations

Amivantamab was granted a conditional marketing authorisation by the European Commission in December 2021 as the first fully-human, bispecific antibody for the monotherapy treatment of patients with NSCLC with EGFR exon 20 insertion mutations, after failure of platinum-based therapy .The latest submission to the EMA is supported by data from the Phase III PAPILLON clinical study (NCT04538664), a randomised, open-label study evaluating the efficacy and safety of amivantamab 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 that the PAPILLON study had met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS; as measured by blinded independent central review [BICR]) in patients receiving amivantamab in combination with chemotherapy versus chemotherapy alone. The combination of amivantamab and chemotherapy demonstrated a safety profile consistent with the safety profiles of the individual components.

“PAPILLON is the first randomised Phase III 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,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We look forward to working with the EMA to bring this potential new indication to the lung cancer community as soon as possible.”

The submission to the EMA follows the recent submission of a supplemental biologics license application (sBLA) to the FDA seeking expanded approval of amivantamab as a first-line combination treatment in patients with advanced or metastatic EGFR exon 20 insertion mutation-positive NSCLC.