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Amivantamab-vmjw Approved for EGFR Exon 20 Insertion–Mutated Non–Small Cell Lung Cancer

Lung cancer histology.

The FDA has granted approval to amivantamab-vmjw (Rybrevant®, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.  

In addition, the FDA granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication was previously granted accelerated approval in May 2021.

Why it matters: "Amivantamab has been approved for the treatment of patients with advanced NSCLC with EGFR exon 20 insertions who have had disease progression during or after platinum-based chemotherapy," wrote Caicun Zhou, PhD, MD, the Director of the Department of Oncology at Shanghai Pulmonary Hospital, and colleagues, in their published results of the PAPILLON trial (NCT04538664), on which approval was based. "Phase 1 data showed the safety and antitumor activity of amivantamab plus carboplatin-pemetrexed (chemotherapy). Additional data on this combination therapy are needed."

What they studied: Efficacy was studied in the phase 3, open-label, multicenter trial in which 308 patients with EGFR exon 20 insertion mutations were enrolled. Patients were randomized 1:1 to receive either amivantamab-vmjw with carboplatin and pemetrexed, or carboplatin and pemetrexed alone.

The primary end point measured was progression-free survival, as assessed by blinded independent central review, with a key secondary end point of overall survival.

What they found: Progression-free survival demonstrated statistically significant improvements in those receiving amivantamab-vmjw with carboplatin and pemetrexed, seen at a median of 11.4 months, compared with carboplatin and pemetrexed, seen at a median of 6.7 months.

At the current analysis, overall survival results are immature, with 44% of prespecified deaths for the final analysis reported. No trend towards a detriment has been observed.

Adverse events: The most common adverse events experienced by ≥20% of patients receiving amivantamab-vmjw with carboplatin and pemetrexed were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting.

Conclusion: "The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertions," concluded Dr. Zhou and colleagues.

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