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Bending the Curve Trial by Trial
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Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials (ALKA-372-001, STARTRK-1, STARTRK-2)

Phase 1/2NCT02097810NCT02568267

Population
Adults with NTRK fusion-positive solid tumours, TRK inhibitor-naive; efficacy-evaluable population
Design
Integrated database of three ongoing phase 1 or 2 trials (ALKA-372-001, STARTRK-1, STARTRK-2; EudraCT 2012-000148-88 for ALKA-372-001) in adults with metastatic or locally advanced NTRK fusion-positive solid tumours given entrectinib at 600 mg or more once daily. Primary endpoints: objective response and median duration of response by blinded independent central review in the efficacy-evaluable population. Data cutoff 31 May 2018.
Primary endpoint
ORR, DOR
Arms
  • Entrectinib (experimental): Entrectinib orally, at least 600 mg once per day (capsule)
People
Doebele RC, senior author Demetri GD
Show the numbers
Results reported for Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials (ALKA-372-001, STARTRK-1, STARTRK-2)
EndpointAnalysisEntrectinibControlEffect
ORREfficacy-evaluable adults with NTRK fusion-positive solid tumours (54 patients, ten tumour types)primarymedian follow-up 12.9 monthsDoebele 202057% (43.2–70.8%)—31 of 54 patients responded, including 4 (7%) complete and 27 (50%) partial responses. Full text (open access, Figure 1A): 1 of 5 patients with thyroid cancer responded.
DOREfficacy-evaluable adults with NTRK fusion-positive solid tumours (54 patients)primarymedian follow-up 12.9 monthsDoebele 2020median 10 months—95% CI 7.1 to not estimable (upper bound cannot be recorded as a number).
Results reported for Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials (ALKA-372-001, STARTRK-1, STARTRK-2)
EndpointAnalysisEntrectinibControlEffect
ORREfficacy-evaluable adults with NTRK fusion-positive solid tumours (54 patients, ten tumour types)primarymedian follow-up 12.9 monthsDoebele 202057% (43.2–70.8%)—31 of 54 patients responded, including 4 (7%) complete and 27 (50%) partial responses. Full text (open access, Figure 1A): 1 of 5 patients with thyroid cancer responded.
DOREfficacy-evaluable adults with NTRK fusion-positive solid tumours (54 patients)primarymedian follow-up 12.9 monthsDoebele 2020median 10 months—95% CI 7.1 to not estimable (upper bound cannot be recorded as a number).
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (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%
666.0%
1340.6%
1926.8%
2517.7%
Primary publication: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, et al. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21(2):271-282. PubMedDOI

Appears in

Sources

  1. Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, et al. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21(2):271-282.

    PubMedDOI