Johnson & Johnson’s (J&J’s) Rybrevant (amivantamab) has been approved by the European Commission (EC) as part of a combination treatment for a new subset of advanced lung cancer patients.
The bispecific antibody has been authorised for use alongside carboplatin and pemetrexed chemotherapy to treat advanced non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
Eligible patients will also have failed on prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
An estimated 484,306 people in Europe were diagnosed with lung cancer in 2022, with NSCLC accounting for up to 85% of all cases.
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have faced a poor prognosis and limited treatment options following disease progression on an EGFR TKI.
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 as a monotherapy and in combination with chemotherapy to treat advanced NSCLC in certain adults with activating EGFR exon 20 insertion mutations.
The EC’s latest approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and is based on 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 AstraZeneca’s TKI Tagrisso (osimertini).
The Rybrevant combination arm met its primary endpoint, significantly reducing the risk of disease progression or death by 52% compared to chemotherapy alone.
Rybrevant plus chemotherapy also showed an objective response rate of 64% versus 36% for chemotherapy alone, and reduced the risk of intracranial progression or death by 45%.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said: “The approval of [Rybrevant] in combination with chemotherapy addresses a major unmet need for those whose disease has progressed following treatment with an EGFR TKI and who, until now, have faced limited treatment options.
“This milestone further reinforces the critical role of precision medicine in driving enhanced outcomes for patients living with lung cancer.”