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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

KEYTRUDA + axitinib achieved superiority across OS, PFS and ORR versus sunitinib.2

Download the trial findings (56KB)

KEYNOTE-426 Phase III, multicenter, open-label, randomised trial vs. sunitinib

Front page of KEYNOTE-426 Slide Deck
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

Kaplan-Meier estimates of OS in KEYNOTE-4262

Adapted from Rini BI, et al., 2019.2 OS was assessed in the intention-to-treat population, defined as all patients who underwent randomization.2

Median overall survival was not reached in either arm of the study.2

An updated OS analysis was performed when patients had a median follow-up of 16.6 months (range: 0.1 to 26.3 months). At the time of this analysis, the hazard ratio in the overall population (95% CI) was 0.59 p=0.0001. P value is nominal only.*3

Hazard ratio presented depicts the hazard ratio for death
*Based upon p value threshold (alpha allocation) planned for the first interim analysis of KN-426.
aBased on the stratified Cox proportional hazard model.

KEYTRUDA + axitinib in first-line treatment of aRCC

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

Adapted from Rini BI, et al., 2019.2 OS was assessed in the intention-to-treat population, defined as all patients who underwent randomization.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 KN-426.
aBased on stratified log-rank test.

KEYTRUDA + axitinib in first-line treatment of aRCC

SUPERIOR OVERALL RESPONSE vs. SUNITINIB2,3

Adapted from Rini BI, et al., 20192

aBased on patients with a best overall response as confirmed complete or partial response.
bBased on Mietinen and Nurminen method stratified by IMDC risk group and geographic region.

abbreviations

Adverse events of any cause that occurred in 10% or more of patients in the as-treated population in KEYNOTE-4262

For the most up to date safety information, please refer to the SPC.3

Adapted from Rini BI, et al., 20192

The most common reason for treatment discontinuation was disease progression. 90 patients discontinued due to disease progression in the prembrolizumab + axitinib arm vs 141 patients in the sunitinib arm.2

Safety was assessed in the as-treated population, which included all randomly assigned patients who received one or more doses of trial treatment.2

adverse events details

References

  1. European Medicines Agency. 2019. KEYTRUDA. https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
  2. 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.
  3. KEYTRUDA Summary of Product Characteristics

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-RCC-00149 | Date of Preparation: July 2020