Johnson & Johnson’s (J&J) Rybrevant (amivantamab) has been approved by the European Commission (EC) as a first-line treatment for non-small cell lung cancer (NSCLC).
The bispecific antibody has been specifically authorised for use alongside carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The approval builds on the EC’s December 2021 conditional marketing authorisation of the drug for use in the same patients after the failure of platinum-based therapy, which has now been converted to standard marketing authorisation.
The regulator’s latest decision was supported by positive results from the late-stage PAPILLON study, in which Rybrevant plus chemotherapy was associated with a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone.
An interim overall survival analysis also showed a favourable trend for patients receiving the Rybrevant combination compared to those in the chemotherapy group.
“Treatment with [Rybrevant] has already been established in the second-line setting, and with this approval in the first-line setting, [Rybrevant] combined with chemotherapy has the potential to redefine the standard of care, offering improved patient outcomes both in terms of clinical efficacy and quality of life,” said trial investigator Nicolas Girard, Institut Curie and Paris Saclay University.
NSCLC accounts for up to 85% of all lung cancer cases and alterations in EGFR are the most common actionable driver mutations in patients with this form of the disease.
EGFR exon 20 insertion mutations are associated with real-world five-year overall survival rates as low as 8%, J&J said, adding that this makes “the introduction of new targeted therapeutic approaches tailored to address the unique complexities of EGFR exon 20 insertion mutations critical”.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, described the approval as “an important development for patients with EGFR exon 20 insertion-mutated NSCLC, who may now benefit from [Rybrevant] plus chemotherapy at the start of their treatment journey”.
The approval announcement came on the same day that J&J said it had received a recommendation from the European Medicines Agency’s human medicines committee for the use of Balversa (erdafitinib) as a once-daily oral monotherapy for specific cases of urothelial carcinoma.