Janssen-Cilag International, a subsidiary of Johnson & Johnson (J&J), has received the European Commission (EC) approval for Rybrevant (amivantamab) plus Lazcluze (lazertinib) to treat a type of non-small cell lung cancer (NSCLC).
The combination is indicated for adults with advanced NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
Rybrevant is a fully human EGFR-MET bispecific antibody that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.
Lazcluze is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.
The EC approval for the Rybrevant plus Lazcluze combination follows the US Food and Drug Administration (FDA) approval in the same indication, granted last year.
Last month, the combination also received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
J&J Innovative Medicine Europe senior director, EMEA oncology therapeutic area lead Henar Hevia said: “This approval marks significant progress for those living with the devastating impact of EGFR-mutated non-small cell lung cancer, who too often face a poor prognosis and limited treatment options.
“The combination of amivantamab and lazertinib exemplifies the potential of targeted precision medicine, offering a tailored approach that addresses the underlying genetic drivers of the disease, and avoids or delays the need for chemotherapy.”
The EC approval is supported by results from the Phase 3 MARIPOSA study, which evaluated Rybrevant plus Lazcluze compared to AstraZeneca’s Tagrisso (osimertinib).
The Phase 3 study met its primary endpoint of progression-free survival (PFS), at a median follow-up of 22 months.
In the study, Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso as evaluated by blinded independent central review (BICR).
The median duration of response (DOR) was longer for patients receiving the combination than Tagrisso, with a nine-month improvement in median DOR.
The combination showed a safety profile that was consistent with previous reports from Phase 1-2 studies, with mostly Grade 1 or 2 adverse events (AEs).
The most common treatment-emergent adverse events (TEAEs) include paronychia, infusion-related reactions, and rash.
Vall d’Hebron University Hospital thoracic cancer unit head Enriqueta Felip said: “For people living with advanced NSCLC harbouring EGFR mutations, new treatment options are urgently needed in the first-line setting.
“The amivantamab and lazertinib combination has shown significant progression-free survival improvements in patients with previously untreated EGFR-mutated advanced NSCLC, including those with brain metastases, compared to osimertinib monotherapy.
“This approval by the European Commission offers the potential to broaden first-line treatment options and provide a new standard of care for eligible patients.”
