FDA Approves Amivantamab for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

By: Dr. Anish Shah
Bronx-Lebanon Hospital; Bronx, NY


On March 1, 2024, the U.S. Food and Drug Administration approved amivantamab-
vmjw (Rybrevant, Janssen Biotech, Inc.) in combination with carboplatin and
pemetrexed for the initial treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbors an epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

Study ID number: NCT04538664.

Approval was based on PAPILLON trial, an open-label multicenter trial that included 308 patients with EGFR exon 20 insertion mutations. Patients were assigned randomly in a 1:1 ratio to either receive amivantamab in combination with carboplatin and pemetrexed or to receive only carboplatin and pemetrexed. Amivantamab was administered with carboplatin and pemetrexed until disease progression or unacceptable toxicity.

Efficacy was established on the primary outcome measure, progression-free survival
(PFS), and the key secondary outcome measure, overall survival (OS). The trial showed a statistically significant improvement in PFS for the amivantamab-vmjw plus
carboplatin and pemetrexed group compared to the carboplatin and pemetrexed group, with a hazard ratio of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). The median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms.

While the overall survival (OS) results are still preliminary at the time of this analysis, with only 44% of the expected deaths reported for the final analysis, there is no observable negative trend at this stage.

Adverse reactions to the medication that occurred in 20% or more of patients included rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting.


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