Kidney Cancer Journal 25
Pembrolizumab plus axitinib versus sunitinib for advanced
renal-cell carcinoma. Rini BI, Plimack ER, Stus
V, et al. N Engl J Med. 2019 Feb 16. doi: 10.1056/NEJMoa1816714.
Summary: The combination of pembrolizumab and axitinib
showed antitumor activity in a phase 1b trial involving
patients with previously untreated advanced
renal-cell carcinoma. Whether pembrolizumab plus axitinib
would result in better outcomes than sunitinib in
such patients was unclear. This open-label, phase 3 trial
randomly assigned 861 patients with previously untreated
advanced clear-cell renal-cell carcinoma to receive
pembrolizumab (200 mg) intravenously once
every 3 weeks plus axitinib (5 mg) orally twice daily
(432 patients) or sunitinib (50 mg) orally once daily for
the first 4 weeks of each 6-week cycle (429 patients). Primary
end points were overall survival and progressionfree
survival in the intention-to-treat population. The
key secondary end point was the objective response
rate. All reported results are from the protocol-specified
first interim analysis. After a median follow-up of 12.8
months, the estimated percentage of patients who were
alive at 12 months was 89.9% in the pembrolizumabaxitinib
group and 78.3% in the sunitinib group. Median
progression-free survival was 15.1 months in the
pembrolizumab-axitinib group and 11.1 months in the
sunitinib group. The objective response rate was 59.3%
in the pembrolizumab-axitinib group and 35.7%in the
sunitinib group (P<0.001). The benefit of pembrolizumab
plus axitinib was observed across the International
Metastatic Renal Cell Carcinoma Database
Consortium risk groups (i.e., favorable, intermediate,
and poor risk) and regardless of programmed death ligand
1 expression. Grade 3 or higher adverse events of
any cause occurred in 75.8% of patients in the pembrolizumab
axitinib group and in 70.6% in the sunitinib
group.
Conclusion: Among patients with previously untreated
advanced RCC, treatment with pembrolizumab plus axitinib
resulted in significantly longer overall survival
and progression-free survival, as well as a higher objective
response rate, than treatment with sunitinib. KCJ
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