The FDA has approved amivantamab-vmjw in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Key Points:

• First and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib in first-line epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC)
• Approval based on Phase 3 MARIPOSA study results
• Reduced risk of disease progression or death by 30% compared to osimertinib
• Median progression-free survival of 23.7 months vs 16.6 months with osimertinib
• Median duration of response 9 months longer than osimertinib (25.8 vs 16.7 months)

The approval follows a Priority Review designation and is based on results from the Phase 3 MARIPOSA study. Amivantamab-vmjw is an EGFR- and MET-directed bispecific antibody, while lazertinib is a highly selective, brain-penetrant, third-generation oral EGFR tyrosine kinase inhibitor.

Safety Profile:

• Most common adverse reactions (≥20%): rash, nail toxicity, infusion-related reactions, musculoskeletal pain, stomatitis, edema, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, decreased appetite, pruritus, nausea, and ocular toxicity
• Serious adverse reactions occurred in 49% of patients
• Fatal adverse reactions occurred in 7% of patients

The approval of this combination therapy represents an advancement in the treatment of EGFR-mutated NSCLC, offering a new chemotherapy-free option for patients in the first-line setting.

Reference: 

Johnson & Johnson. RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. PR Newswire. August 20, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-approved-in-the-us-as-a-first-line-chemotherapy-free-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer-301904531.html