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Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma.

Publication ,  Journal Article
Apolo, AB; Ballman, KV; Sonpavde, G; Berg, S; Kim, WY; Parikh, R; Teo, MY; Sweis, RF; Geynisman, DM; Grivas, P; Chatta, G; Reichert, ZR ...
Published in: N Engl J Med
September 15, 2024

BACKGROUND: Muscle-invasive urothelial carcinoma is an aggressive disease with high rates of relapse. Whether pembrolizumab as adjuvant therapy would be effective in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery is unknown. METHODS: In this phase 3 trial, we randomly assigned patients, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks for 1 year or to undergo observation. Randomization was stratified according to pathological stage, centrally tested programmed death ligand 1 (PD-L1) status, and previous neoadjuvant chemotherapy. The coprimary end points were disease-free survival and overall survival in the intention-to-treat population. We considered the trial to be successful if either disease-free survival or overall survival was significantly longer with pembrolizumab than with observation. RESULTS: A total of 702 patients underwent randomization; 354 were assigned to receive pembrolizumab, and 348 were assigned to observation. As of July 5, 2024, the median duration of follow-up for disease-free survival was 44.8 months. The median disease-free survival was 29.6 months (95% confidence interval [CI], 20.0 to 40.7) with pembrolizumab and 14.2 months (95% CI, 11.0 to 20.2) with observation (hazard ratio for disease progression or death, 0.73; 95% CI, 0.59 to 0.90; two-sided P = 0.003). Grade 3 or higher adverse events (regardless of attribution) occurred in 50.7% of the patients in the pembrolizumab group and in 31.6% of the patients in the observation group. CONCLUSIONS: Among patients with high-risk muscle-invasive urothelial carcinoma after radical surgery, disease-free survival was significantly longer with adjuvant pembrolizumab than with observation. (Funded by the National Cancer Institute of the National Institutes of Health and others; Alliance A031501 AMBASSADOR ClinicalTrials.gov number, NCT03244384.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 15, 2024

Location

United States

Related Subject Headings

  • General & Internal Medicine
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences
 

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Apolo, A. B., Ballman, K. V., Sonpavde, G., Berg, S., Kim, W. Y., Parikh, R., … Rosenberg, J. E. (2024). Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. https://doi.org/10.1056/NEJMoa2401726
Apolo, Andrea B., Karla V. Ballman, Guru Sonpavde, Stephanie Berg, William Y. Kim, Rahul Parikh, Min Yuen Teo, et al. “Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma.N Engl J Med, September 15, 2024. https://doi.org/10.1056/NEJMoa2401726.
Apolo AB, Ballman KV, Sonpavde G, Berg S, Kim WY, Parikh R, et al. Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2024 Sep 15;
Apolo, Andrea B., et al. “Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma.N Engl J Med, Sept. 2024. Pubmed, doi:10.1056/NEJMoa2401726.
Apolo AB, Ballman KV, Sonpavde G, Berg S, Kim WY, Parikh R, Teo MY, Sweis RF, Geynisman DM, Grivas P, Chatta G, Reichert ZR, Kim JW, Bilen MA, McGregor B, Singh P, Tripathi A, Cole S, Simon N, Niglio S, Ley L, Cordes L, Srinivas S, Huang J, Odegaard M, Watt C, Petrylak D, Hoffman-Censits J, Wen Y, Hahn O, Mitchell C, Tan A, Streicher H, Sharon E, Moon H, Woods M, Halabi S, Perez Burbano G, Morris MJ, Rosenberg JE. Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2024 Sep 15;

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 15, 2024

Location

United States

Related Subject Headings

  • General & Internal Medicine
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences