US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that the European Commission (EC) has granted label extension approval for its Rybrevant (amivantamab) combined with Lazcluze (lazertinib) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations.
Amivantamab: A Fully-Human EGFR-MET Bispecific Antibody
Amivantamab, which received its first approval in the US in May 2021, is a fully-human EGFR-MET bispecific antibody used to treat NSCLC patients with EGFR exon 20 insertion mutations. This label extension approval significantly broadens the patient population that may benefit from this treatment.
Lazertinib: A Third-Generation EGFR Tyrosine Kinase Inhibitor
Lazertinib, developed by South Korean pharmaceutical company Yuhan, is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Yuhan granted ex-South Korea rights to J&J in 2018, and the drug was approved in South Korea and the US in 2021 and 2024, respectively.
Positive Results from Phase III MARIPOSA Study
The EC’s approval is based on positive results from the Phase III MARIPOSA study, which showed that the combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30 percent compared to osimertinib (median PFS: 23.7 months versus 16.6 months; hazard ratio [HR]=0.70). Additionally, the median duration of response (DOR) was longer for patients receiving the combination therapy, with a nine-month improvement in median DOR (25.8 vs. 16.8 months).
Safety Profile of the Combo Treatment
The safety profile of the combination treatment is consistent with previous studies, with most adverse reactions being controllable, further supporting the use of this treatment approach in advanced NSCLC.-Fineline Info & Tech
