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PROFILE 1001 (ROS1 cohort)

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Phase 1N = 50NCT00585195

Population
Advanced NSCLC testing positive for ROS1 rearrangement
Design
ROS1-positive expansion cohort of the phase 1 crizotinib study: crizotinib 250 mg orally twice daily, assessed for safety, pharmacokinetics and response. The full text states that the primary end point of the expansion study was the response rate and that tumour assessments were performed by the investigators.
Primary endpoint
ORR
Arms
  • Crizotinib (experimental, n = 50): Crizotinib 250 mg orally twice daily
People
Shaw AT
Show the numbers
Results reported for PROFILE 1001 (ROS1 cohort)
EndpointAnalysisCrizotinibControlEffect
ORRROS1-positive expansion cohort (n=50)primaryShaw 201472% (58–84%)—3 complete and 33 partial responses. Response assessed by investigators (full text, PMC4264527).
DORROS1-positive expansion cohort (n=50)primaryShaw 2014median 17.6 months—95% CI 14.5 to not reached.
PFSROS1-positive expansion cohort (n=50)primaryShaw 2014median 19.2 months—95% CI 14.4 to not reached; 25 patients (50%) were still in follow-up for progression.
Results reported for PROFILE 1001 (ROS1 cohort)
EndpointAnalysisCrizotinibControlEffect
ORRROS1-positive expansion cohort (n=50)primaryShaw 201472% (58–84%)—3 complete and 33 partial responses. Response assessed by investigators (full text, PMC4264527).
DORROS1-positive expansion cohort (n=50)primaryShaw 2014median 17.6 months—95% CI 14.5 to not reached.
PFSROS1-positive expansion cohort (n=50)primaryShaw 2014median 19.2 months—95% CI 14.4 to not reached; 25 patients (50%) were still in follow-up for progression.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%010203040Months (modelled)
  • Crizotinib (experimental)

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

Data table (modelled values)
MonthsCrizotinib
0100.0%
1164.8%
2242.0%
3327.3%
4417.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Crizotinib (experimental)

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

Data table (modelled values)
MonthsCrizotinib
0100.0%
1264.8%
2442.0%
3627.3%
4817.7%
Primary publication: Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371(21):1963-71. PubMedDOI

Appears in

Sources

  1. Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371(21):1963-71.

    PubMedDOI