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INVICTUS

Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial

Phase 3N = 129NCT03353753

Population
Adults with advanced GIST with progression on at least imatinib, sunitinib and regorafenib, or documented intolerance to any of them despite dose modifications; ECOG 0-2
Design
Double-blind, randomised (2:1), placebo-controlled phase 3 trial at 29 hospitals in 12 countries. Ripretinib 150 mg once daily or placebo; stratified by number of previous therapies and ECOG performance status. Placebo patients could cross over to ripretinib 150 mg at progression. Primary analysis in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Ripretinib (experimental, n = 85): Ripretinib 150 mg once daily
  • Placebo (control, n = 44): Placebo once daily (crossover to ripretinib allowed at progression)
People
Blay JY, Deciphera Pharmaceuticals
PFSHR 0.15 (95% CI 0.09–0.25)Δ median PFS+5.3 months
Show the numbers
Results reported for INVICTUS
EndpointAnalysisRipretinibPlaceboEffect
PFSAssessed by blinded independent central review (BICR); double-blind periodprimaryBlay 2020median 6.3 months (4.6–6.9)median 1 month (0.9–1.7)HR 0.15 (95% CI 0.09–0.25)P<0.0001Median follow-up 6.3 months (IQR 3.2 to 8.2) in the ripretinib group and 1.6 months (1.1 to 2.7) in the placebo group. Progression-free survival events: 51 (ripretinib) and 37 (placebo).
Results reported for INVICTUS
EndpointAnalysisRipretinibPlaceboEffect
PFSAssessed by blinded independent central review (BICR); double-blind periodprimaryBlay 2020median 6.3 months (4.6–6.9)median 1 month (0.9–1.7)HR 0.15 (95% CI 0.09–0.25)P<0.0001Median follow-up 6.3 months (IQR 3.2 to 8.2) in the ripretinib group and 1.6 months (1.1 to 2.7) in the placebo group. Progression-free survival events: 51 (ripretinib) and 37 (placebo).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.150.09–0.25
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Ripretinib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsRipretinibPlacebo
0100.0%100.0%
464.4%6.3%
841.5%0.4%
1226.7%0.0%
1617.2%0.0%
Primary publication: Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020;21(7):923-934. PubMedDOI

Appears in

Sources

  1. Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020;21(7):923-934.

    PubMedDOI