HRQoL data analysis of KEYNOTE-426: pembrolizumab combined with axitinib vs. sunitinib in the treatment of advanced renal cell carcinoma

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Guide

Based on the results of the global phase III KEYNOTE-426 clinical study, pembrolizumab combined with axitinib has been approved by European and American countries for the first-line treatment
of advanced renal clear cell carcinoma (RCC).
RECENTLY, THE ANALYSIS RESULTS OF KEYNOTE-426 HEALTH-RELATED QUALITY OF LIFE (HRQoL) were published in the journal european urology.

Research background

Compared with sunitinib monotherapy, pembrolizumab plus axitinib significantly improved overall survival, progression-free survival, and objective response rates in patients with RCC, but the effect of both regimens on HRQoL in patients with RCC is unknown
.
Preliminary evidence suggests that combination immunotherapy has a positive effect
on HRQoL and disease-related symptoms in patients.
Based on this, the researchers analyzed
the HRQoL results in KEYNOTE-426.

Study design

The study design of KEYNOTE-426 has previously been reported, with a total of 861 patients randomized 1:1 to receive either pembrolizumab + axitinib (n=432) or sunitinib (n=429) monotherapy
.
The investigators used three validated assessment tools to detect and analyze patient-reported outcomes (PROs) in two groups: the Quality of Life Measurement Scale for Cancer Patients (QLQ-C30), the European Five-Dimensional Health Scale (EQ-5D VAS), and the Renal Cancer Cancer Treatment Function Assessment - Disease-Associated Symptoms Scale (FKSI-DRS
).

Study results

Compared with the sunitinib group, the pembrolizumab + axitinib group had better improvement than baseline PROs (QLQ-C30 score improved by 7.
5%, 95% CI 1.
0–14; EQ-5D VAS score improved by 9.
9%, 95% CI 3.
2–17) or no difference (FKSI-DRS score increased by -0.
79%, 95% CI -7.
2–5.
6 compared with sunitinib group).

Table 1 Changes in the two groups of PROs from baseline to week 30

No significant difference between groups was observed between groups in QLQ-C30 (HR=1.
0, 95% CI 0.
82–1.
3) and time to first exacerbation (TTfD) (HR=0.
82, 95% CI 0.
69–0.
97), as well as in EQ-5D VAS, TTcD (HR=1.
1, 95% CI 0.
87–1.
3), TTfD (HR=0.
98, 95% CI 0.
83–1.
2)
。 In FKSI-DRS, there was no difference in TTfD between groups (HR = 1.
1, 95% CI 0.
95–1.
3), but TTcD results were better in the sunitinib group (HR = 1.
4, 95% CI 1.
1–1.
7), because assessing patients during sunitinib withdrawal may have reduced the negative effects of sunitinib and thus influenced the results of
the between-group comparison.

Conclusion of the study

Overall, pembrolizumab + axitinib delayed disease progression and prolonged survival compared with sunitinib, and no significant difference in HRQoL outcomes was found between the two regimens, and these data further support the use of pembrolizumab + axitinib as the standard of care
for first-line treatment in patients with RCC.

References:

Bedke J, Rini BI, Plimack ER, et al.
Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma.
Eur Urol.
2022 Oct; 82(4):427-439.