Janssen seeks approval from EMA for NSCLC combo therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted an application seeking approval from the European Medicines Agency (EMA) for the non-small cell lung cancer (NSCLC) combo therapy RYBREVANT (amivantamab) plus chemotherapy (carboplatin and pemetrexed).

The application for type II extension of this combo therapy is intended for the first-line treatment of adults with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The fully human EGFR-MET bispecific antibody amivantamab has immune cell-directing activity, which acts on tumours with activating and resistance EGFR mutations, and mutations and amplifications in the MET gene.

Janssen submitted the application based on data from the Phase III PAPILLON clinical study.

The open-label, randomised study assesses the safety and efficacy of amivantamab along with chemotherapy.

In July 2023, the PAPILLON trial attained its primary endpoint with an improvement in progression-free survival (PFS) in patients receiving amivantamab in combination with chemotherapy compared with chemotherapy alone.

The company’s latest submission follows the recent supplemental biologics licence application submission (sBLA) to the US Food and Drug Administration to receive expanded approval for amivantamab as a first-line combination treatment in patients with advanced or metastatic EGFR exon 20 insertion mutation-positive NSCLC.

Janssen research and development, clinical development and solid tumours vice-president Kiran Patel stated: “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.”

In December 2021, the European Commission granted conditional marketing authorisation for amivantamab as the first fully human, bispecific antibody for the monotherapy treatment of NSCLC patients with EGFR exon 20 insertion mutations who had failed platinum-based therapy.