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KEYTRUDA® (pembrolizumab) with axitinib: approved by the EMA for first line treatment of advanced Renal Cell Carcinoma (RCC) in adults1

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 plus axitinib achieved superiority across OS, PFS and ORR versus sunitinib.2,3

study design

Primary endpoints: overall survival and progression-free survival in the intention-to-treat population2

Secondary end points: Objective response rate, duration of response and safety2

the original analysis

Updated Analysis, 42.8 months median follow up

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

Kaplan-Meier estimates of OS in KEYNOTE-4262

Adapted from Rini et al. 2021.3 OS was assessed in the intention-to-treat population, defined as all patients who underwent randomisation.3

Median overall survival was 45.7 months (43.6–not reached) for KEYTRUDA plus axitinib and 40.1 months (34.3–44.2) for sunitinib. Adapted from Rini BI et al. 2021.2

Latest median follow-up data is presented. Data cut off 11 January 2021. Median follow up 42.8 months (35.6-50.6 months). Adapted from Rini BI et al. 2021.2

In an earlier analysis when patients had a median follow up of 16.6 months (0.1–26.3 months), the hazard ratio (95% CI) for the overall population was 0.59, p=0.0001. P value is nominal only. Adapted from Rini BI et al. 2019.*4

Hazard ratio presented depicts the hazard ratio for death
*Based upon p value threshold (alpha allocation) planned for the first interim analysis of KEYNOTE-426.
aBecause superiority of KEYTRUDA plus axitinib was shown at the first interim analysis, no alpha was allocated to overall survival; only nominal p values are reported.

KEYTRUDA plus axitinib in first-line treatment of aRCC

SUPERIOR PROGRESSION-FREE SURVIVAL (PFS) vs. SUNITINIB2,3

Adapted from Rini et al. 2021.3 PFS was assessed in the intention-to-treat population, defined as all patients who underwent randomisation.3

Latest median follow-up data is presented. Data cut off 11 January 2021. Median follow-up 42.8 months (35.6-50.6 months). Adapted from Rini BI et al. 2021.2

Hazard ration presented depicts the hazard ratio for disease progression and death.
*Based upon p value threshold (alpha allocation) planned for the first interim analysis of KEYNOTE-426.
aBecause superiority of KEYTRUDA plus axitinib was shown at the first interim analysis, no alpha was allocated to overall survival; only nominal p values are reported.

KEYTRUDA axitinib in first-line treatment of aRCC

SUPERIOR OVERALL RESPONSE vs. SUNITINIB2,3

Adapted from Rini BI et al. 2021.2

Latest median follow-up data is presented. Data cut off 11 January 2021. Median follow-up 42.8 months (35.6-50.6 months). Adapted from Rini BI et al. 2021.2

aBecause superiority of KEYTRUDA plus axitinib was shown at the first interim analysis, no alpha was allocated to objective response; only nominal p values are reported.

abbreviations

Adverse events of any cause that occurred in 10% or more of patients in the as-treated population in KEYNOTE-4263

For the most up to date safety information, please refer to the SPC.4

Adapted from Rini BI, et al., 20193

The most common reason for treatment discontinuation was disease progression. 88 patients discontinued due to disease progression in the prembrolizumab plus axitinib arm vs 147 patients in the sunitinib arm.3

Safety was assessed in the as-treated population, which included all randomly assigned patients who received one or more doses of trial treatment.3

adverse events details

References

  1. European Medicines Agency. 2019. KEYTRUDA. https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda.
  2. Rini BI et al. Presented at ASCO 2021 Virtual Annual Meeting.
  3. Rini BI, Plimack ER, Stus V, et al; for the KEYNOTE-426 investigators. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1116–1127.
  4. KEYTRUDA Summary of Product Characteristics.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-RCC-00271 | Date of Preparation: August 2021