Anticipation is building for U.S. FDA approval of Yuhan Corp.’s Leclaza (ingredient: lazertinib) and Janssen's Rybrevant (ingredient: amivantamab) as a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC). This follows the MARIPOSA phase 3 study of the combination therapy published in the New England Journal of Medicine (NEJM).

Janssen, a subsidiary of Johnson & Johnson, submitted a new drug application (NDA) to the FDA at the end of last year, and the FDA is set to make a decision no later than Aug. 21.

The MARIPOSA study compared the effectiveness of amivantamab-lazertinib combination therapy with osimertinib, a standard treatment for EGFR-mutated NSCLC. The study’s lead researcher was Professor Cho Byoung-chul, director of the Lung Cancer Center at Yonsei Cancer Center.

The study involved 1,074 patients with previously untreated EGFR-mutated (exon 19 deletion or L858R), locally advanced, or metastatic NSCLC. Participants were assigned in a 2:2:1 ratio to receive either the combination therapy, osimertinib, or lazertinib alone.

The results revealed that the median progression-free survival (PFS) was significantly longer in the amivantamab-lazertinib group (23.7 months) compared to the osimertinib group (16.6 months), with a hazard ratio for disease progression or death of 0.70.

Also, an objective response was observed in 86 percent of the patients in the amivantamab–lazertinib group and in 85 percent of those in the osimertinib group.

Among patients with a confirmed response, the median response duration was notably longer in the combination therapy group (25.8 months) compared to the osimertinib group (16.8 months).

In a planned interim overall survival analysis, the hazard ratio for death was 0.80, indicating a trend towards improved survival with the combination therapy.

However, the predominant adverse events were EGFR-related toxic effects, and the incidence of discontinuation of all agents due to treatment-related adverse events was higher with the combination therapy (10 percent) compared to osimertinib (3 percent).

For more information, visit the NEJM website or refer to the publication: "Amivantamab plus Lazertinib versus Osimertinib in Untreated EGFR-Mutated Advanced NSCLC."