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KEYNOTE-052

First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer

Phase 2N = 374NCT02335424

Population
Cisplatin-ineligible patients with advanced urothelial cancer not previously treated with systemic chemotherapy
Design
Multicentre, single-arm phase 2 study; pembrolizumab 200 mg intravenously every 3 weeks. Primary endpoint objective response (all patients and by PD-L1 status) per RECIST 1.1 by independent central review.
Primary endpoint
ORR
Arms
  • Pembrolizumab (experimental, n = 370): Pembrolizumab 200 mg every 3 weeks (up to 24 months in the long-term report)
People
Balar AV
Show the numbers
Results reported for KEYNOTE-052
EndpointAnalysisPembrolizumabControlEffect
ORRAll patients treated (n = 370)Objective response by independent central review per RECIST 1.1primarymedian follow-up 5 monthsBalar 201724% (20–29%)——
ORRPD-L1 combined positive score of 10% or more (n = 110)primarymedian follow-up 5 monthsBalar 201738% (29–48%)——
ORRAll patients treated (n = 370)long term-updateVuky 202028.6% (24.1–33.5%)—Minimum follow-up 2 years from enrolment of the last patient.
DORResponderslong term-updateVuky 2020median 30.1 months—95% CI 18.1 months to not reached.
OSAll patients treated (n = 370)long term-updateVuky 2020median 11.3 months (9.7–13.1); 46.9% at 12 mo; 31.2% at 2 y——
ORRPD-L1 combined positive score of 10% or morelong term-updateVuky 202047.3% (37.7–57.0%)——
OSPD-L1 combined positive score of 10% or morelong term-updateVuky 2020median 18.5 months (12.2–28.5)——
Results reported for KEYNOTE-052
EndpointAnalysisPembrolizumabControlEffect
ORRAll patients treated (n = 370)Objective response by independent central review per RECIST 1.1primarymedian follow-up 5 monthsBalar 201724% (20–29%)——
ORRPD-L1 combined positive score of 10% or more (n = 110)primarymedian follow-up 5 monthsBalar 201738% (29–48%)——
ORRAll patients treated (n = 370)long term-updateVuky 202028.6% (24.1–33.5%)—Minimum follow-up 2 years from enrolment of the last patient.
DORResponderslong term-updateVuky 2020median 30.1 months—95% CI 18.1 months to not reached.
OSAll patients treated (n = 370)long term-updateVuky 2020median 11.3 months (9.7–13.1); 46.9% at 12 mo; 31.2% at 2 y——
ORRPD-L1 combined positive score of 10% or morelong term-updateVuky 202047.3% (37.7–57.0%)——
OSPD-L1 combined positive score of 10% or morelong term-updateVuky 2020median 18.5 months (12.2–28.5)——
Illustrative — modelled from reported values, not trial data. DOR, long term-update.
0%25%50%75%100%0204060Months (modelled)
  • Pembrolizumab (experimental)

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

Data table (modelled values)
MonthsPembrolizumab
0100.0%
1964.6%
3841.7%
5627.5%
7517.8%
Illustrative — modelled from reported values, not trial data. OS, long term-update.
0%25%50%75%100%0510152025Months (modelled)
  • Pembrolizumab (experimental)
Data table (modelled values)
MonthsPembrolizumab
0100.0%
671.1%
1344.3%
1935.8%
2631.2%
Primary publication: Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(11):1483-1492. PubMedDOI

Appears in

Sources

  1. Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(11):1483-1492.

    PubMedDOI

  2. Vuky J, Balar AV, Castellano D, O'Donnell PH, Grivas P, Bellmunt J, et al. Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2020;38(23):2658-2666.

    PubMedDOI