Johnson & Johnson (J&J) has announced that its chemotherapy-free combination has been approved by the European Commission (EC) for a subset of epidermal growth factor receptor (EGFR)-mutated lung cancer patients.
Rybrevant (amivantamab), an EGFR-MET bispecific antibody, plus Lazcluze (lazertinib), a third-generation EGFR tyrosine kinase inhibitor (TKI), has been approved for the first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The EC’s decision was based on positive results from the late-stage MARIPOSA study, which compared Rybrevant plus Lazcluze against the current first-line standard of care, AstraZeneca’s own third-generation EGFR-TKI Tagrisso (osimertinib), in this patient population.
The trial met its primary endpoint, with J&J’s combination demonstrating a 30% reduction in the risk of disease progression or death compared to Tagrisso at a median follow-up of 22 months.
The median duration of response was also longer for patients receiving Rybrevant plus Lazcluze compared to Tagrisso, at 25.8 versus 16.8 months, and the safety profile of the combination was consistent with previous reports from phase 1 to 2 studies.
NSCLC accounts for up to 85% of all lung cancer cases, and alterations in EGFR are among the most common driver mutations in patients with this form of the disease.
Patients are often treated with EGFR TKIs. However, treatment resistance and disease recurrence remains a significant challenge and there is an urgent need for alternative targeted therapies earlier in the treatment pathway, according to J&J.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said the EC’s approval “marks significant progress for those living with the devastating impact of EGFR-mutated NSCLC, who too often face a poor prognosis and limited treatment options”.
“The combination of [Rybrevant] and [Lazcluze] 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,” she said.
The decision comes just over four months after the EC approved Rybrevant for use alongside carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with EGFR exon 19 deletions or exon 21 L858R substitution mutations who have failed on prior therapy, including an EGFR TKI.