PEMBROLIZUMAB PLUS AXITINIB VERSUS

SUNITINIB FOR ADVANCED RENAL-CELL

CARCINOMA (KEYNOTE-426
TRIAL)
DATA SUMMARY AND STUDY OUTCOME

By: Dr. Manoj Kumar

 Patients Demographics and Clinical Characteristics
Characteristic Pembrolizumab–Axitinib Sunitinib
(N = 432) (N = 429)

Age Median (range) — yr 62 (30–89) 61 (26–90)

IMDC prognostic risk — no. (%)† Favorable 138 (31.9) 131 (30.5)
Intermediate 238 (55.1) 246 (57.3)
Poor 56 (13.0) 52 (12.1)
Sarcomatoid features — no./total no. 51/285 (17.9) 54/293 (18.4)
with known status (%)

No. of organs with metastases — no. 1 114 (26.4) 96 (22.4)

(%)
≥2 315 (72.9) 331 (77.2)
Previous radiotherapy — no. (%) 41 (9.5) 40 (9.3)
Previous nephrectomy — no. (%) 357 (82.6) 358 (83.4)

“Patient demographics and baseline clinical characteristics were balanced across study groups.”
 Overall Survival Rate
Pembrolizumab plus Axitinib Vs Sunitinib
◦ Overall significant increase in survival rate of pembrolizumab-axitinib group as compared to sunitinib group (fig a)
◦ 47% higher survival was seen in pembrolizumab-axitinib group {Hazard ratio for death, 0.53 (95% CI, 0.38–0.74)
P<0.0001}
◦ Overall survival was comparatively higher in both 12 and 18 months follow-up in pembrolizumab-axitinib group

Follow-up Pembrolizumab-axitinib Sunitinib

12 months 89.9% (95% CI, 86.4 to 92.4) 78.3% (95% CI, 73.8 to 82.1)

18 months 82.3% (95% CI, 77.2 to 86.3) 72.1% (95% CI, 66.3 to 77.0)

Figure a: Kaplan-Meier
plot for Overall Survival
Rate
 Progression free survival rate (PFS)
Significantly higher PFS rate was seen in pembrolizumab-axitinib group as compared to sunitinib group (fig b)
31% higher PFS rate seen in pembrolizumab-axitinib group {0.69 (95% CI, 0.57–0.84) P<0.001}
PFS was 15.1 months in pembrolizumab-axitinib group whereas 11.1 months in sunitinib group

Variable Pembrolizumab-axitinib Sunitinib

Progression free survival

15.1 months 11.1 months
rate

Fig b: Kaplan-Meier plot for

progression free survival rate
 Objective Response Rate & Adverse Events
o Significantly higher objective response rate was seen in pembrolizumab-axitinib group as compared to sunitinib
group (fig c)
o Statistically significant (P<0.001),23.6 % higher objective response pembrolizumab–axitinib group (59.3% ( 95%
CI, 54.5 to 63.9)as compared to sunitinib group (35.7% (95 % CI, 31.1 to 40.4)}.
o No difference in numbers of adverse events were observed in both the groups (fig d)

Fig c: Bar Objective Response Rate Fig D: Pie Adverse Events

graph for *** Chart for
overall Adverse
response 60.00% Evens
50.00%
rate Pembrolizumab-axitinib
40.00% Sunitinib
99.50%; 50% 98.40%; 50%
30.00%

20.00%

10.00%

0.00%
Pembrolizumab-axitinib Sunitinib
 CONCLUSION
Patients treated with pembrolizumab plus axitinib lead to
◦ Significant increase in the overall survival rate
◦ Significant was seen in progression free survival rate
◦ Overall higher response rate
◦ Approx. same number of adverse events
as compared to sunitinib treated group.

Beneficial effect of the pembrolizumab-axitinib were observed with same number of

adverse events as compared to sunitinib group.

References: 1. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell
Carcinoma. 2019;380(12):1116-27 doi: 10.1056/NEJMoa1816714[published Online First: Epub Date]|.