KEYNOTE-436 trial: QoL is the same for both arms in mRCC

The trial demonstrated a significant survival advantage for intermediate and poor-risk patients with metastatic renal-cell carcinoma who received pembrolizumab + axitinib as compared to those receiving sunitinib.

There were also no differences between the treatment groups with regard to time to deterioration

The KEYNOTE-426 trial demonstrated a significant survival advantage for intermediate and poor-risk patients with metastatic renal-cell carcinoma (mRCC) who received pembrolizumab with axitinib as compared to those who received sunitinib. Prof. Jens Bedke (University of Tübingen, Germany) found no evidence of a clinically important difference in the quality of life (QoL) between the 2 study arms at any point during the 30 weeks of examination1.

With a median follow-up of 30.6 months, KEYNOTE-426 demonstrated that pembrolizumab and axitinib (n=432) had a significant benefit compared to sunitinib (n=429) in intermediate or poor-risk mRCC patients in terms of overall survival (HR 0.68; 95% CI 0.55 -0.85), progression-free survival (HR 0.71; 95% CI 0.60-0.84), and objective response rate (60% vs 40%). 

Key endpoints with regard to the patient-reported outcome analyses included time to deterioration and change from baseline over time. The primary analysis time point was 30 weeks. Assessment of time to deterioration was continued up to week 90.

Patient-reported outcome assessment was performed with the following instruments, although arm-specific adjustment to the treatment protocol changed the scheduling between the arms: 

  1. QLQ-C30: general QoL in cancer patients;
  2. FKSI-DRS: 9 kidney-cancer specific cancer-related symptoms;
  3. EuroQol EQ-5D-3L VAS: general state of health.

The primary outcome –change from baseline over time– never met the threshold for minimally important differences between the 2 study arms at any point during the 30 weeks examined, with any of the validated instruments. The researchers, therefore, concluded that health-related QoL in patients treated with combination pembrolizumab and axitinib was similar to those receiving sunitinib monotherapy. There were also no differences between the treatment groups with regard to time to deterioration (HR 1.12; 95% CI 0.91-1.38) in the confirmed analysis, as well as in the unconfirmed analysis (HR 1.02; 95% CI 0.86-1.20).

Reference:
1. Bedke J, et al. Health-related quality-of-life (HRQoL) analysis from KEYNOTE-426: pembrolizumab (pembro) plus axitinib (axi) vs sunitinib for advanced renal cell carcinoma (RCC). EAU20 Virtual Congress, 17-26 July 2020, Game-changing Session 4.

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