Skip to content
Bending the Curve Trial by Trial
?

JAVELIN Bladder 100

Maintenance avelumab plus best supportive care versus best supportive care alone after first-line platinum-based chemotherapy in unresectable locally advanced or metastatic urothelial carcinoma

Phase 3N = 700NCT02603432

Population
Unresectable locally advanced or metastatic urothelial cancer without progression after first-line platinum-based chemotherapy
Design
Randomised phase 3 trial; patients whose disease had not progressed after four to six cycles of first-line gemcitabine plus cisplatin or carboplatin received best supportive care with or without maintenance avelumab. Primary endpoint overall survival, in all randomised patients and in those with PD-L1-positive tumours.
Primary endpoint
OS
Arms
  • Maintenance avelumab plus best supportive care (experimental): Avelumab maintenance plus best supportive care
  • Best supportive care alone (control): Best supportive care
People
Powles T
OSHR 0.69 (95% CI 0.56–0.86)Δ median OS+7.1 monthsΔ 12-month OS+12.9 pointsOSHR 0.56 (95% CI 0.40–0.79)Δ 12-month OS+18.7 pointsPFSHR 0.62 (95% CI 0.52–0.75)
Show the numbers
Results reported for JAVELIN Bladder 100
EndpointAnalysisMaintenance avelumab plus best supportive careBest supportive care aloneEffect
OSAll randomised patients (n = 700)primaryPowles 2020median 21.4 months; 71.3% at 12 momedian 14.3 months; 58.4% at 12 moHR 0.69 (95% CI 0.56–0.86)P=0.001
OSPD-L1-positive tumoursprimaryPowles 202079.1% at 12 mo60.4% at 12 moHR 0.56 (95% CI 0.40–0.79)P<0.001
PFSAll randomised patients (n = 700)primaryPowles 2020median 3.7 monthsmedian 2 monthsHR 0.62 (95% CI 0.52–0.75)
PFSPD-L1-positive tumoursprimaryPowles 2020median 5.7 monthsmedian 2.1 monthsHR 0.56 (95% CI 0.43–0.73)
Results reported for JAVELIN Bladder 100
EndpointAnalysisMaintenance avelumab plus best supportive careBest supportive care aloneEffect
OSAll randomised patients (n = 700)primaryPowles 2020median 21.4 months; 71.3% at 12 momedian 14.3 months; 58.4% at 12 moHR 0.69 (95% CI 0.56–0.86)P=0.001
OSPD-L1-positive tumoursprimaryPowles 202079.1% at 12 mo60.4% at 12 moHR 0.56 (95% CI 0.40–0.79)P<0.001
PFSAll randomised patients (n = 700)primaryPowles 2020median 3.7 monthsmedian 2 monthsHR 0.62 (95% CI 0.52–0.75)
PFSPD-L1-positive tumoursprimaryPowles 2020median 5.7 monthsmedian 2.1 monthsHR 0.56 (95% CI 0.43–0.73)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOSPFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.690.56–0.86
OS0.560.4–0.79
PFS0.620.52–0.75
PFS0.560.43–0.73
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Maintenance avelumab plus best supportive care (experimental)
  • Best supportive care alone (control)

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

Data table (modelled values)
MonthsMaintenance avelumab plus best supportive careBest supportive care alone
0100.0%100.0%
1365.6%53.3%
2741.7%27.0%
4027.4%14.4%
5417.4%7.3%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468Months (modelled)
  • Maintenance avelumab plus best supportive care (experimental)
  • Best supportive care alone (control)

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

Data table (modelled values)
MonthsMaintenance avelumab plus best supportive careBest supportive care alone
0100.0%100.0%
268.8%50.0%
539.2%17.7%
726.9%8.8%
918.5%4.4%
Primary publication: Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383(13):1218-1230. PubMedDOI

Appears in

Sources

  1. Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383(13):1218-1230.

    PubMedDOI