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Advanced Urothelial Carcinoma: Post Platinum-containing Chemotherapy

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.

KEYTRUDA® (pembrolizumab) is indicated as monotherapy for adults with locally advanced or metastatic urothelial carcinoma who have had prior platinum containing chemotherapy.1

KEYNOTE-045 study design2

KEYNOTE-045: A positive Phase 3 trial of an immune-checkpoint inhibitor to successfully demonstrate significantly increased overall survival vs. chemotherapy in advanced urothelial cancer. 2

Co-primary endpoints consisted of overall survival and progression-free survival in the total and PD-L1 combined score ≥10 populations. Secondary endpoints consisted of objective response rate and duration of confirmed response in the total and PD-L1 combined score ≥10 populations and safety in the total population only.2

The original analysis2

Updated analysis, 62.9 month median follow up

No conclusion can be drawn from the follow-up data as no statistical analysis was performed.

Overall Survival in the ITT population3

Overall Survival in the ITT population

The intention-to-treat population included all the patients who underwent randomisation.2

Latest median follow-up data is presented. Data cut off October 1, 2020. Median follow up 62.9 months (58.6-70.9 months). Adapted from Bellmunt J et al. 2021.3

In an earlier analysis, OS rates at 1 year were 44.2% with KEYTRUDA vs. 29.8% with chemotherapy.2

In patients with greater levels of PD-L1-expressing tumours (CPS ≥10), there was a 41% reduction in the risk of death with KEYTRUDA vs. chemotherapy3

Progression-free survival in the ITT population3

Progression-free survival in the ITT population

The intention-to-treat population included all the patients who underwent randomisation.2

Latest median follow-up data is presented. Data cut off October 1, 2020. Median follow-up 62.9 months (58.6-70.9 months). Adapted from Bellmunt J et al. 2021.3

Objective response rate in the ITT population3

Objective response rate in the ITT population

The intention-to-treat population included all the patients who underwent randomisation.2

Latest median follow-up data is presented. Data cut off October 1, 2020. Median follow-up 62.9 months (58.6-70.9 months). Adapted from Bellmunt J et al. 2021.3

  • Almost double the objective response rate demonstrated with KEYTRUDA vs. chemotherapy3
  • KEYTRUDA also more than trebled the rate of complete responses vs. chemotherapy3

After a median follow-up of 62.9 months (58.6-70.9 months), DOR was 29.7 months with pembrolizumab and 4.4 months with chemotherapy. Data cut off 1 October 2020.3

Summary of safety data from KEYNOTE-045

Related content

 

References

  1. Summary of Product Characteristics.
  2. Bellmunt J. et al. N Eng J Med 2017;376:1015-1026.
  3. Bellmunt J et al. Presented at ASCO 2021 Virtual Annual Meeting.
  4. Necchi A et al. Presented at ESMO 2019. Barcelona, Spain.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-RCC-00282 | Date of Preparation: August 2021