CHMP positive recommendation for Rybrevant (amivantamab) in combination with chemotherapy for first-line treatment of non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.- Janssen Cilag (J&J)

“The PAPILLON study results represent an important advancement in the EGFR exon 20 insertion NSCLC treatment landscape, demonstrating significantly improved progression-free survival with first-line amivantamab plus chemotherapy, versus chemotherapy alone,” said trial investigator Professor Nicolas Girard, Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris Saclay University, France. “Notably, we observed improvements in functional status and reduction in lung cancer-related symptoms, underscoring the potential of this regimen to redefine standards of care for these patients, offering hope for improved quality of life and patient-relevant treatment outcomes.”

An urgent need exists for innovative treatments in NSCLC, particularly for patients with EGFR exon 20 insertion driver mutations, due to the significant disease burden. EGFR exon 20 insertion mutations are the third most common activating EGFR mutation and are associated with real-world five-year overall survival rates as low as 8%. This reinforces the critical demand for targeted therapeutic approaches, tailored to address the unique complexities of EGFR exon 20 insertion mutations, aiming to substantially improve patient survival and quality of life outcomes.