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DESTINY-Lung01

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

Phase 2N = 91NCT03505710

Population
Metastatic HER2-mutant NSCLC refractory to standard treatment (HER2-mutant cohort of the study)
Design
Multicentre, international, open-label, two-cohort phase 2 study; this record covers the HER2-mutant cohort: trastuzumab deruxtecan 6.4 mg per kilogram in metastatic HER2-mutant NSCLC refractory to standard treatment. The paper notes the lack of a comparator group. Primary outcome objective response by independent central review.
Primary endpoint
ORR
Arms
  • Trastuzumab deruxtecan (experimental, n = 91): Trastuzumab deruxtecan 6.4 mg per kilogram of body weight
People
Li BT
Show the numbers
Results reported for DESTINY-Lung01
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORREnrolled HER2-mutant cohort (n=91)Centrally confirmed objective response by independent central reviewprimarymedian follow-up 13.1 monthsLi 202255% (44–65%)—Adjudicated drug-related interstitial lung disease occurred in 26% of patients and was fatal in 2 patients; grade 3 or higher drug-related adverse events 46%.
DOREnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 9.3 months (5.7–14.7)——
PFSEnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 8.2 months (6.0–11.9)——
OSEnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 17.8 months (13.8–22.1)——
Results reported for DESTINY-Lung01
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORREnrolled HER2-mutant cohort (n=91)Centrally confirmed objective response by independent central reviewprimarymedian follow-up 13.1 monthsLi 202255% (44–65%)—Adjudicated drug-related interstitial lung disease occurred in 26% of patients and was fatal in 2 patients; grade 3 or higher drug-related adverse events 46%.
DOREnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 9.3 months (5.7–14.7)——
PFSEnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 8.2 months (6.0–11.9)——
OSEnrolled HER2-mutant cohort (n=91)primarymedian follow-up 13.1 monthsLi 2022median 17.8 months (13.8–22.1)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Trastuzumab deruxtecan (experimental)

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

Data table (modelled values)
MonthsTrastuzumab deruxtecan
0100.0%
663.9%
1240.9%
1728.2%
2318.0%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Trastuzumab deruxtecan (experimental)

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

Data table (modelled values)
MonthsTrastuzumab deruxtecan
0100.0%
565.5%
1042.9%
1528.1%
2116.9%
Primary publication: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, et al. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022;386(3):241-251. PubMedDOI

Appears in

Sources

  1. Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, et al. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022;386(3):241-251.

    PubMedDOI