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Amivantamab plus lazertinib
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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The FDA previously approved amivantamab for patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertions whose disease progressed during or after platinum-based chemotherapy. Lazertinib is a third-generation EGFR TKI.
Evidence (amivantamab plus lazertinib):
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The median PFS was 23.7 months in the amivantamab-lazertinib group and 16.6 months in the osimertinib group (HRdisease progression or death, 0.70; 95% CI, 0.58–0.85; P < .001).[52][Level of evidence B1]
Source links and citations
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The objective response rate was 86% in the amivantamab-lazertinib group (95% CI, 83%–89%) and 85% in the osimertinib group (95% CI, 81%–88%).
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The median DOR was 25.8 months (95% CI, 20.1–not estimable [NE]) in the amivantamab-lazertinib group and 16.8 months (95% CI, 14.8-18.5) in the osimertinib group.
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The HRdeath was 0.80 (95% CI, 0.61–1.05).
The international phase III MARIPOSA trial (NCT04487080) included 1,074 patients with untreated advanced or metastatic NSCLC and EGFR variants (EGFR exon 19 deletion or EGFR L858R). Patients were randomly assigned in a 2:2:1 ratio to receive amivantamab plus lazertinib (429 patients, in an open-label fashion), osimertinib (429 patients, in a blinded fashion), or lazertinib (216 patients, in a blinded fashion). The primary end point of the study was PFS for the amivantamab-lazertinib group compared with the osimertinib group, as assessed by blinded independent central review. At a median follow-up of 22.0 months, the median duration of treatment was 18.5 months (range, 0.2–31.4) in the amivantamab-lazertinib group and 18.0 months (range, 0.2–32.7) in the osimertinib group.[52]
The treatment discontinuation rate due to adverse events was 10% in the amivantamab-lazertinib group and 3% in the osimertinib group.
The FDA approved the amivantamab-lazertinib combination as first-line treatment for patients with locally advanced or metastatic NSCLC and EGFR exon 19 or EGFR L858R variants.
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