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Bending the Curve Trial by Trial
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MARIPOSA

Amivantamab plus lazertinib versus osimertinib in previously untreated EGFR-mutated advanced NSCLC (MARIPOSA)

Phase 3N = 1,074NCT04487080

Population
Previously untreated EGFR-mutated (exon 19 deletion or L858R) locally advanced or metastatic NSCLC
Design
International randomised phase 3 trial, 2:2:1 allocation to amivantamab-lazertinib (open-label), osimertinib (blinded) or lazertinib (blinded, to assess the contribution of components); primary endpoint PFS (amivantamab-lazertinib versus osimertinib) by blinded independent central review
Primary endpoint
PFS
Arms
  • Amivantamab plus lazertinib (experimental, n = 429): Amivantamab plus lazertinib
  • Osimertinib (control, n = 429): Osimertinib
  • Lazertinib (experimental, n = 216): Lazertinib
People
Cho BC, MARIPOSA Investigators
PFSHR 0.70 (95% CI 0.58–0.85)Δ median PFS+7.1 monthsΔ ORR+1 pointsΔ median DOR+9 monthsOSHR 0.80 (95% CI 0.61–1.05)OSHR 0.75 (95% CI 0.61–0.92)
Show the numbers
Results reported for MARIPOSA
EndpointAnalysisAmivantamab plus lazertinib / LazertinibOsimertinibEffect
PFSAmivantamab-lazertinib versus osimertinib (n=429 each)Blinded independent central reviewprimaryCho 2024median 23.7 monthsmedian 16.6 monthsHR 0.70 (95% CI 0.58–0.85)P<0.001
ORRAmivantamab-lazertinib versus osimertinib (n=429 each)primaryCho 202486% (83–89%)85% (81–88%)—
DORPatients with a confirmed response (336 and 314)primaryCho 2024median 25.8 monthsmedian 16.8 months (14.8–18.5)Among 336 patients with a confirmed response with amivantamab-lazertinib and 314 with osimertinib. The 95% confidence interval for the amivantamab-lazertinib median is 20.1 months to could-not-be-estimated (upper bound cannot be stored).
OSAmivantamab-lazertinib versus osimertinib (n=429 each)interimCho 2024——HR 0.80 (95% CI 0.61–1.05)
OSAmivantamab-lazertinib versus osimertinib (n=429 each)finalmedian follow-up 37.8 monthsYang 202560% at 3 y51% at 3 yHR 0.75 (95% CI 0.61–0.92)P=0.005Protocol-specified final overall survival analysis; a key secondary endpoint.
Results reported for MARIPOSA
EndpointAnalysisAmivantamab plus lazertinib / LazertinibOsimertinibEffect
PFSAmivantamab-lazertinib versus osimertinib (n=429 each)Blinded independent central reviewprimaryCho 2024median 23.7 monthsmedian 16.6 monthsHR 0.70 (95% CI 0.58–0.85)P<0.001
ORRAmivantamab-lazertinib versus osimertinib (n=429 each)primaryCho 202486% (83–89%)85% (81–88%)—
DORPatients with a confirmed response (336 and 314)primaryCho 2024median 25.8 monthsmedian 16.8 months (14.8–18.5)Among 336 patients with a confirmed response with amivantamab-lazertinib and 314 with osimertinib. The 95% confidence interval for the amivantamab-lazertinib median is 20.1 months to could-not-be-estimated (upper bound cannot be stored).
OSAmivantamab-lazertinib versus osimertinib (n=429 each)interimCho 2024——HR 0.80 (95% CI 0.61–1.05)
OSAmivantamab-lazertinib versus osimertinib (n=429 each)finalmedian follow-up 37.8 monthsYang 202560% at 3 y51% at 3 yHR 0.75 (95% CI 0.61–0.92)P=0.005Protocol-specified final overall survival analysis; a key secondary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.70.58–0.85
OS0.80.61–1.05
OS0.750.61–0.92
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Amivantamab plus lazertinib (experimental)
  • Osimertinib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAmivantamab plus lazertinibOsimertinib
0100.0%100.0%
1564.5%53.5%
3041.6%28.6%
4427.6%15.9%
5917.8%8.5%
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Amivantamab plus lazertinib (experimental)
  • Osimertinib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAmivantamab plus lazertinibOsimertinib
0100.0%100.0%
1665.1%51.7%
3242.3%26.7%
4827.5%13.8%
6517.4%6.8%
Primary publication: Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, et al. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024;391(16):1486-1498. PubMedDOI

Appears in

Sources

  1. Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, et al. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024;391(16):1486-1498.

    PubMedDOI

  2. Yang JC, Lu S, Hayashi H, Felip E, Spira AI, Girard N, et al. Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2025;393(17):1681-1693.

    PubMedDOI