Amivantamab (EGFR/MET bispecific) + carbo/pem doubles PFS vs chemo alone in 1L EGFR exon20ins NSCLC (China subgroup)
- Trial ID
- NCT04538664 on ClinicalTrials.gov
- Cancer type
- Non-Small Cell Lung Cancer (NSCLC)
- Published in
- New in Oncology - June 11, 2026
Amivantamab is an IV EGFR/MET bispecific antibody designed to block ligand binding/signaling and drive immune-mediated tumor killing; here it was combined with carboplatin–pemetrexed in the randomized, open-label Phase 3 PAPILLON trial (Chinese mainland subgroup; NCT04538664) in treatment-naïve, locally advanced/metastatic EGFR exon 20 insertion NSCLC (n=87; 39 combo vs 48 chemo). Blinded independent central review showed median PFS 12.3mo vs 6.7mo (HR 0.47, 95% CI 0.26–0.85; nominal p=0.0109) with an 18-mo PFS rate of 33% vs 12%, and ORR 71.8% vs 48.9% (odds ratio 2.46; nominal p=0.0478)—directionally better than historical platinum/pemetrexed-only outcomes in this genotype (PFS typically ~6–7mo, ORR ~30–50%), and consistent with the overall PAPILLON dataset. Safety was chemo-like plus expected amivantamab toxicities (notably rash; cytopenias including neutropenia/anemia/leukopenia); no new safety signals were reported and no patients discontinued amivantamab for treatment-related AEs.
Take home
If the OS signal matures, this regimen looks like a practical “new default” first-line backbone for EGFR exon20ins NSCLC (a relatively small slice of EGFR+ disease—often cited around ~2–12% of EGFR-mutant NSCLC), though the open-label design and nominal p-values in this subgroup mean we should treat the China-only estimates as supportive rather than definitive.
Source: Read the original publication
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