European Commission Approves Marketing Authorization for Lazertinib Plus Amivantamab in Certain Patients With NSCLC

The European Commission (EC) has approved a Marketing Authorization for lazertinib (Lazcluze) plus amivantamab (Rybrevant) as a first-line treatment for adults with advanced non–small cell lung cancer (NSCLC) who have EGFR exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations, according to Janssen-Cilag International NV, a Johnson & Johnson company.

This EC action follows the EC’s December 2024 approval of a type II variation extension of indication for amivantamab plus lazertinib as the first-line treatment for adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

The EC Marketing Authorization approval is supported by results from the phase 3 MARIPOSA study, which compared lazertinib plus amivantamab with single-agent osimertinib as a first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or exon 21 L858R substitution mutations, according to Johnson & Johnson. The phase 3 MARIPOSA trial enrolled 1,074 patients, with a primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review.

The MARIPOSA study met its primary endpoint of PFS. A recent announcement indicates that the phase 3 study also met its prespecified secondary endpoint of overall survival (OS), showing a “clinically meaningful and statistically significant improvement in OS versus the current standard of care, osimertinib monotherapy,” Johnson & Johnson officials said in the press release.

Stephen Liu, MD, associate professor of medicine at Georgetown University School of Medicine and director of Thoracic Oncology and Head of Developmental Therapeutics at Georgetown’s Lombardi Comprehensive Cancer Center, discussed the implications of the OS results with Lung Cancers Today in a recent interview.

“When we think of how to process these data, this announcement that survival was better with this MARIPOSA regimen, it supports the fact that being more aggressive upfront really alters the history… survival is a hard endpoint and looks at the treatment sequence in totality,” Dr. Liu said in the interview.

The median OS with the combination regimen is “expected to exceed one year,” and “these landmark OS data will be presented at an upcoming medical meeting,” Johnson & Johnson officials said.

Antonio Passaro, MD, PhD, a medical oncologist, of the Division of Thoracic Oncology, European Institute of Oncology in Milan, Italy, weighed in on the recent OS results in a statement provided by Johnson & Johnson.

“This chemotherapy-free regimen has already demonstrated significant progression-free survival improvements, and new topline data suggests it is expected to extend life by a median of one year or more, in patients with untreated EGFR-mutated NSCLC versus the current standard of care, osimertinib,” Dr. Passaro said. “These results mark a significant step forward in the treatment of EGFR-mutated NSCLC. Extending life expectancy is a critical indicator of a treatment’s impact. The MARIPOSA study reaffirms the potential of first-line treatment with this combination therapy to redefine the standard of care and offer clinically meaningful improvements in outcomes for patients.”

Henar Hevia, PhD, senior director and EMEA therapeutic area lead in oncology, explained in a statement what this approval could mean for patients and families.

“Currently, the five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors is less than 20 percent,” Dr. Hevia said in a statement provided by Johnson & Johnson. “Today’s approval marks an important moment in lung cancer care, bringing a new option to patients through a chemotherapy-free regimen, and potentially offering more time with their loved ones.”

The combination of amivantamab-vmjw plus lazertinib was approved in August 2024 in the United States as a first-line treatment for patients with EGFR-mutated NSCLC and was also based on the phase 3 MARIPOSA study.

Source: Johnson & Johnson