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CHRYSALIS

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

Phase 1N = 81NCT02609776

Population
EGFR exon 20 insertion-mutated NSCLC progressing on platinum-based chemotherapy (efficacy population, n=81; safety population n=114)
Design
Open-label phase 1 dose-escalation and dose-expansion study. The report covers the post-platinum EGFR exon 20 insertion NSCLC population at the recommended phase 2 dose of amivantamab 1,050 mg (1,400 mg if 80 kg or more) weekly for 4 weeks then every 2 weeks. Primary endpoints dose-limiting toxicity and overall response rate.
Primary endpoint
ORR
Arms
  • Amivantamab (experimental, n = 81): Amivantamab 1,050 mg (1,400 mg if 80 kg or more) weekly for 4 weeks, then every 2 weeks
People
Park K
Show the numbers
Results reported for CHRYSALIS
EndpointAnalysisAmivantamabControlEffect
ORRPost-platinum efficacy population (n=81)primaryPark 202140% (29–51%)—Including 3 complete responses.
DORPost-platinum efficacy population (n=81)primaryPark 2021median 11.1 months—95% CI 6.9 to not reached.
PFSPost-platinum efficacy population (n=81)primaryPark 2021median 8.3 months (6.5–10.9)——
Results reported for CHRYSALIS
EndpointAnalysisAmivantamabControlEffect
ORRPost-platinum efficacy population (n=81)primaryPark 202140% (29–51%)—Including 3 complete responses.
DORPost-platinum efficacy population (n=81)primaryPark 2021median 11.1 months—95% CI 6.9 to not reached.
PFSPost-platinum efficacy population (n=81)primaryPark 2021median 8.3 months (6.5–10.9)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Amivantamab (experimental)

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

Data table (modelled values)
MonthsAmivantamab
0100.0%
764.6%
1441.7%
2126.9%
2817.4%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Amivantamab (experimental)

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

Data table (modelled values)
MonthsAmivantamab
0100.0%
565.9%
1043.4%
1626.3%
2117.3%
Primary publication: Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, et al. Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study. J Clin Oncol. 2021;39(30):3391-3402. PubMedDOI

Appears in

Sources

  1. Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, et al. Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study. J Clin Oncol. 2021;39(30):3391-3402.

    PubMedDOI