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Bending the Curve Trial by Trial
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ALKA-372-001, STARTRK-1 and STARTRK-2 (integrated)

Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials

Phase 1/2N = 53NCT02097810NCT02568267

Population
Adults with locally advanced or metastatic ROS1 fusion-positive NSCLC; previous cancer treatment other than ROS1 inhibitors allowed (efficacy-evaluable population, 53 patients)
Design
Integrated analysis of three phase 1 or 2 trials (ALKA-372-001, STARTRK-1, STARTRK-2) of entrectinib at 600 mg or more once daily in locally advanced or metastatic ROS1 fusion-positive NSCLC with at least 12 months' follow-up. Primary endpoints objective response and duration of response by blinded independent central review. ALKA-372-001 is registered in EudraCT (2012-000148-88), not ClinicalTrials.gov.
Primary endpoint
ORR, DOR
Arms
  • Entrectinib (experimental, n = 53): Entrectinib at least 600 mg orally once daily
People
Drilon A
Show the numbers
Results reported for ALKA-372-001, STARTRK-1 and STARTRK-2 (integrated)
EndpointAnalysisEntrectinibControlEffect
ORREfficacy-evaluable population (n=53)primarymedian follow-up 15.5 monthsDrilon 202077% (64–88%)—41 of 53 patients had an objective response. Grade 3 or 4 treatment-related adverse events occurred in 34% of the 134 patients in the safety population.
DOREfficacy-evaluable population (n=53)primarymedian follow-up 15.5 monthsDrilon 2020median 24.6 months (11.4–34.8)——
Results reported for ALKA-372-001, STARTRK-1 and STARTRK-2 (integrated)
EndpointAnalysisEntrectinibControlEffect
ORREfficacy-evaluable population (n=53)primarymedian follow-up 15.5 monthsDrilon 202077% (64–88%)—41 of 53 patients had an objective response. Grade 3 or 4 treatment-related adverse events occurred in 34% of the 134 patients in the safety population.
DOREfficacy-evaluable population (n=53)primarymedian follow-up 15.5 monthsDrilon 2020median 24.6 months (11.4–34.8)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Entrectinib (experimental)

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

Data table (modelled values)
MonthsEntrectinib
0100.0%
1565.5%
3141.7%
4627.4%
6217.4%
Primary publication: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, et al. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21(2):261-270. PubMedDOI

Appears in

Sources

  1. Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, et al. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21(2):261-270.

    PubMedDOI