Johnson & Johnson’s (J&J) Rybrevant (amivantamab) has been recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for a subset of advanced non-small cell lung cancer (NSCLC) patients.
The bispecific antibody has been specifically recommended by the Committee for Medicinal Products for Human Use (CHMP) alongside carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations, after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
Lung cancer is the leading cause of cancer-related deaths globally and NSCLC accounts for up to 85% of all diagnoses.
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options following disease progression on AstraZeneca’s TKI Tagrisso (osimertini).
J&J’s Rybrevant is designed to directly block EGFR on the outside of the cell to stop tumours from growing and is already approved in the EU to treat advanced NSCLC in certain adults with activating EGFR exon 20 insertion mutations.
The CHMP’s latest recommendation of the therapy was supported by positive results from the late-stage MARIPOSA-2 study, which evaluated Rybrevant plus chemotherapy in patients with locally-advanced or metastatic EGFR ex19del or L858R substitution NSCLC whose disease had progressed on or after treatment with Tagrisso.
The trial met its primary endpoint, with the Rybrevant combination reducing the risk of disease progression or death by 52% compared to chemotherapy alone and demonstrating an objective response rate of 64% versus 36%.
Kiran Patel, vice president, clinical development, solid tumours, J&J Innovative Medicine, said: “[Rybrevant] has already shown positive outcomes in treating patients with other EGFR mutations, and we now look forward to the next steps in making it available to further patients with common EGFR mutations after progression on [Tagrisso].”
The recommendation comes just one month after Rybrevant was approved by the European Commission in combination with carboplatin and pemetrexed chemotherapy as a first-line treatment for advanced NSCLC in adults with EGFR exon 20 insertion mutations.