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Bending the Curve Trial by Trial
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PAPILLON

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

Phase 3N = 308NCT04538664

Population
Advanced NSCLC with EGFR exon 20 insertions, no previous systemic therapy
Design
International randomised (1:1) phase 3 trial: intravenous amivantamab plus carboplatin-pemetrexed versus carboplatin-pemetrexed alone in previously untreated advanced NSCLC with EGFR exon 20 insertions. Primary endpoint PFS by blinded independent central review. Crossover to amivantamab monotherapy allowed on progression in the chemotherapy group.
Primary endpoint
PFS
Arms
  • Carboplatin-pemetrexed (control, n = 155): Carboplatin-pemetrexed chemotherapy alone
  • Amivantamab plus carboplatin-pemetrexed (experimental, n = 153): Intravenous amivantamab plus carboplatin-pemetrexed
People
Zhou C
PFSHR 0.40 (95% CI 0.30–0.53)Δ median PFS+4.7 monthsΔ ORR+26 pointsOSHR 0.67 (95% CI 0.42–1.09)
Show the numbers
Results reported for PAPILLON
EndpointAnalysisAmivantamab plus carboplatin-pemetrexedCarboplatin-pemetrexedEffect
PFSRandomised patients (n=308)PFS according to blinded independent central reviewprimaryZhou 2023median 11.4 monthsmedian 6.7 monthsHR 0.40 (95% CI 0.30–0.53)P<0.001Progression-free survival at 18 months 31% with amivantamab-chemotherapy and 3% with chemotherapy alone.
ORRRandomised patients (n=308)Complete or partial response at data cutoffprimaryZhou 202373%47%P<0.001Rate ratio 1.50 (95% CI 1.32 to 1.68).
OSRandomised patients (n=308)interimZhou 2023——HR 0.67 (95% CI 0.42–1.09)P=0.11Interim overall survival analysis at 33% maturity; not significant.
Results reported for PAPILLON
EndpointAnalysisAmivantamab plus carboplatin-pemetrexedCarboplatin-pemetrexedEffect
PFSRandomised patients (n=308)PFS according to blinded independent central reviewprimaryZhou 2023median 11.4 monthsmedian 6.7 monthsHR 0.40 (95% CI 0.30–0.53)P<0.001Progression-free survival at 18 months 31% with amivantamab-chemotherapy and 3% with chemotherapy alone.
ORRRandomised patients (n=308)Complete or partial response at data cutoffprimaryZhou 202373%47%P<0.001Rate ratio 1.50 (95% CI 1.32 to 1.68).
OSRandomised patients (n=308)interimZhou 2023——HR 0.67 (95% CI 0.42–1.09)P=0.11Interim overall survival analysis at 33% maturity; not significant.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.40.3–0.53
OS0.670.42–1.09
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Carboplatin-pemetrexed (control)
  • Amivantamab plus carboplatin-pemetrexed (experimental)

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

Data table (modelled values)
MonthsCarboplatin-pemetrexedAmivantamab plus carboplatin-pemetrexed
0100.0%100.0%
748.5%65.3%
1423.5%42.7%
2111.4%27.9%
295.0%17.1%
Primary publication: Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, et al. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023;389(22):2039-2051. PubMedDOI

Appears in

Sources

  1. Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, et al. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023;389(22):2039-2051.

    PubMedDOI