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Advanced Urothelial Carcinoma: for patients ineligible for cisplatin

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) as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults; who have received prior platinum-containing chemotherapy, or who are not eligible for cisplatin containing chemotherapy and whose tumours express PD-L1 with a combined positive score ≥ 10.1

KEYNOTE-052 study design

The primary endpoint was objective response in all patients and by PD-L1 expression status.2

The secondary endpoints were to establish a cutoff for PD-L1 strongly positive expression status and to determine duration of response (per RECIST version 1.1), overall survival, progression-free survival (per RECIST version 1.1), and safety and tolerability.2

The original analysis

KEYTRUDA can offer:

Objective Response Rate

47% Almost half of patients with a CPS ≥ 10 had an objective response to KEYTRUDA (95% CI, 38-57; n=52/110)3

Objective Response Rate was the primary endpoint in KEYNOTE-052. The objective response to KEYTRUDA in all patients was 29%.3

The latest data cut off is presented – Median duration of follow up was 56.3 months (range, 51.2–65.3). Data cut off was 26 September 20203

The baseline and prognostic disease characteristics of the KEYNOTE-052 study population included a proportion of patients eligible for a carboplatin-based combination, for whom the benefit has been assessed in a comparative study (KEYNOTE-361).

In KEYNOTE-361, a higher number of deaths within 6 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). No specific factor(s) associated with early deaths were identified.

Physicians should consider the delayed onset of effects before initiating treatment with pembrolizumab in patients with urothelial carcinoma who are considered eligible for carboplatin-based combination chemotherapy.

Overall Survival

19 months median overall survival with KEYTRUDA in patients with CPS ≥ 10 (95% CI, 12.2-28.5, n-110)3

Objective Response Rate was the primary endpoint in KEYNOTE-052. Secondary endpoints were Duration of response, progression-free survival, overall survival, safety and tolerability.2

Median duration of follow up was 56.3 months (range, 51.2–65.3). Data cut off was 26 September 2020.3

11 months median overall survival with KEYTRUDA in all patients regardless of PD-L1 score (95% CI, 9.7-13.1; n=370).3

Duration of Response

Latest data cut off is presented. September 26, 2021 (median follow-up 56.3 months). Adapted from O'Donnell PH et al. 2021.3

Objective Response Rate was the primary endpoint in KEYNOTE-052. Secondary endpoints were Duration of response, progression-free survival, overall survival, safety and tolerability.2

Updated Analysis, 56.3 months median follow up

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

Summary of safety data from KEYNOTE-052
Why should you be confident in KEYTRUDA?

References

  1. KEYTRUDA Summary of Product Characteristics.
  2. Balar AV et al. Lancet Oncol 2017;doi:10.1016/S1470-2045(17)30616-2.
  3. O’Donnell PH et al. Presented as ASCO 2021 Virtual Annual Meeting.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-PDO-01601 | Date of Preparation: August 2021