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  • / Post hoc pooled analysis of first-line (1L) pembrolizumab (pembro) for advanced urothelial carcinoma (UC): Outcomes by response at week nine in KEYNOTE-052 and KEYNOTE-361.

Post hoc pooled analysis of first-line (1L) pembrolizumab (pembro) for advanced urothelial carcinoma (UC): Outcomes by response at week nine in KEYNOTE-052 and KEYNOTE-361.

Abstract Video & Slides Poster

Authors

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Thomas Powles

Barts Cancer Institute, Queen Mary University of London, London, United Kingdom

Thomas Powles , Ajjai Shivaram Alva , Mustafa Ozguroglu , Peter H. O'Donnell , Yohann Loriot , Tibor Csoszi , Jacqueline Vuky , Rafael Morales-Barrera , Elizabeth R. Plimack , Nobuaki Matsubara , Yves Fradet , Lajos Geczi , Seyda Gunduz , Ronac Mamtani , Dean F. Bajorin , Chih-Chin Liu , Kentaro Imai , Blanca Homet Moreno , Joaquim Bellmunt , Arjun Vasant Balar

Organizations

Barts Cancer Institute, Queen Mary University of London, London, United Kingdom, University of Michigan Health System, Ann Arbor, MI, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey, The University of Chicago, Chicago, IL, Gustave Roussy, Cancer Campus, and University of Paris-Saclay, Villejuif, France, County Oncology Centre, Hetényi Géza Hospital, Szolnok, Hungary, Oregon Health & Science University, Portland, OR, Vall d’Hebron Institute of Oncology, Vall d’ Hebron University Hospital, and Autonomous University of Barcelona, Barcelona, Spain, Fox Chase Cancer Center, Philadelphia, PA, National Cancer Center Hospital East, Chiba, Japan, CHU de Quebec-University of Laval, Quebec City, QC, Canada, National Institute of Oncology, Budapest, Hungary, Memorial Antalya Hospital, Antalya, Turkey, Abramson Cancer Center, Penn Medicine, Philadelphia, PA, Memorial Sloan Kettering Cancer Center, New York, NY, Merck & Co., Inc., Kenilworth, NJ, Beth Israel Deaconess Medical Center/IMIM Research Institute, Harvard Medical School, Boston, MA, Perlmutter Cancer Center, NYU Langone Health, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: Pembro is a 1L treatment for cisplatin-ineligible pts with UC. This post hoc landmark analysis evaluated clinical outcomes by response at 9 wk to 1L pembro monotherapy in pts with advanced/unresectable or metastatic UC from the single-arm phase 2 KEYNOTE-052 (NCT02335424) and the randomized phase 3 KEYNOTE-361 (NCT02853305) trials. Methods: Cisplatin-ineligible pts with advanced UC were enrolled in KEYNOTE-052 and received pembro (200 mg Q3W for ≤2 y). Platinum-eligible pts with advanced UC who had not previously received systemic chemotherapy (chemo) were enrolled in KEYNOTE-361 and randomly assigned 1:1:1 to receive pembro (200 mg Q3W for ≤2 y), pembro + chemo (1000 mg/m2 gemcitabine on d1 and d8 + cisplatin [70 mg/m2] or carboplatin [AUC 5] on d1 of each 3-wk cycle), or chemo. The primary analysis group included pembro monotherapy–treated pts; the sensitivity analysis group included pembro monotherapy–treated pts from KEYNOTE-052 and the choice of carboplatin subpopulation of pembro monotherapy–treated pts from KEYNOTE-361. Landmark analyses of OS by pts with CR, PR, SD, or PD per RECIST v1.1 by BICR at first imaging assessment (wk 9) were pooled for the ITT populations. Duration of CR/PR/SD and OS were estimated using the Kaplan-Meier method. Data cutoffs were Sep 26, 2020 (KEYNOTE-052) and Apr 29, 2020 (KEYNOTE-361). Results: The primary analysis group included 681 pembro-treated pts (KEYNOTE-052, N = 374; KEYNOTE-361, N = 307); the sensitivity analysis group included 544 pembro-treated pts (KEYNOTE-052, N = 374; KEYNOTE-361, N = 170). Median time from randomization to cutoff was 51.9 mo (range, 22.0-65.3) and 53.7 mo (range, 22.0-65.3) for the primary and sensitivity analysis groups, respectively. Twenty-five pts (4.6%) had CR and 135 (24.6%) had PR (primary group); 17 pts (3.9%) had CR and 105 (24.1%) had PR (sensitivity group). Median DOR was 25.9 mo for pts with CR/PR at wk 9; pts with CR/PR or SD at wk 9 had longer OS than pts with PD at wk 9 (Table). Conclusions: In this post hoc analysis, pts with advanced UC in KEYNOTE-052 and KEYNOTE-361 with CR/PR at wk 9 had better clinical outcomes with pembro monotherapy than pts with SD or PD; 1L pembro monotherapy continues to show efficacy in advanced UC. Clinical trial information: NCT02335424 and NCT02853305.

Pooled outcomes by response at week nine.
Primary AnalysisCR/PR
n = 160
SD
n = 154
PD
n = 234
Median OS from wk 9, mo (95% CI)51.4 (36.9-NR)17.5 (14.5-24.7)5.9 (5.0-7.2)
36-month OS rate from wk 9, % (95% CI)62.5 (54.0-69.9)28.5 (21.1-36.3)4.8 (2.4-8.4)
Duration of CR/PR/SD, median (range), mo25.9 (0.0-60.7+)4.2 (0.0-51.5+)NA
Sensitivity Analysisn = 122n = 125n = 188
Median OS from wk 9, mo (95% CI)50.7 (36.2-NR)17.5 (13.3-24.7)5.3 (4.0-6.5)
36-month OS rate from wk 9, % (95% CI)60.7 (51.1-68.9)29.2 (21.1-37.8)4.9 (2.3-8.8)
Duration of CR/PR/SD, median (range), mo26.2 (0.0-60.7+)4.2 (0.0-51.5+)NA

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Abstract Details

Meeting

2022 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Urothelial Carcinoma

Track

Urothelial Carcinoma

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02335424 and NCT02853305

Citation

J Clin Oncol 40, 2022 (suppl 6; abstr 519)

DOI

10.1200/JCO.2022.40.6_suppl.519

Abstract #

519

Poster Bd #

G7

Abstract Disclosures

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