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CABOSUN

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

Phase 2N = 157NCT01835158

Population
Untreated clear cell metastatic renal cell carcinoma, IMDC intermediate or poor risk, ECOG performance status 0 to 2
Design
Randomised (1:1) multicentre phase 2 trial (Alliance A031203) of cabozantinib 60 mg once daily versus sunitinib 50 mg once daily (4 weeks on, 2 weeks off) as first-line therapy; ECOG performance status 0 to 2; International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate or poor risk. Primary end point progression-free survival; objective response rate, overall survival and safety were secondary. One-sided P value reported for PFS.
Primary endpoint
PFS
Arms
  • Cabozantinib (experimental, n = 79): Cabozantinib 60 mg orally once daily
  • Sunitinib (control, n = 78): Sunitinib 50 mg orally once daily, 4 weeks on and 2 weeks off
People
Choueiri TK, senior author Morris MJ, Alliance for Clinical Trials in Oncology
PFSHR 0.66 (95% CI 0.46–0.95)Δ median PFS+2.6 monthsΔ ORR+21 points
Show the numbers
Results reported for CABOSUN
EndpointAnalysisCabozantinibSunitinibEffect
PFSRandomised patients as described in the abstract (analysis population not stated there)primaryChoueiri 2017median 8.2 monthsmedian 5.6 monthsHR 0.66 (95% CI 0.46–0.95)P=0.012 (one-sided)Adjusted hazard ratio; the abstract reports a one-sided P value of .012.
ORRRandomised patients as described in the abstract (analysis population not stated there)primaryChoueiri 201733% (23–44%)12% (5.4–21.0%)—
Results reported for CABOSUN
EndpointAnalysisCabozantinibSunitinibEffect
PFSRandomised patients as described in the abstract (analysis population not stated there)primaryChoueiri 2017median 8.2 monthsmedian 5.6 monthsHR 0.66 (95% CI 0.46–0.95)P=0.012 (one-sided)Adjusted hazard ratio; the abstract reports a one-sided P value of .012.
ORRRandomised patients as described in the abstract (analysis population not stated there)primaryChoueiri 201733% (23–44%)12% (5.4–21.0%)—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.660.46–0.95
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Cabozantinib (experimental)
  • Sunitinib (control)

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

Data table (modelled values)
MonthsCabozantinibSunitinib
0100.0%100.0%
565.5%53.9%
1042.9%29.0%
1528.1%15.6%
2116.9%7.4%
Primary publication: Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, et al. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. J Clin Oncol. 2017;35(6):591-597. PubMedDOI

Appears in

Sources

  1. Choueiri TK, Halabi S, Sanford BL, Hahn O, Michaelson MD, Walsh MK, et al. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. J Clin Oncol. 2017;35(6):591-597.

    PubMedDOI