Kidney Cancer Journal 31
MEDICAL INTELLIGENCE
(continued from page 9)
IMmotion150 is the first randomized clinical trial to evaluate
the combination of atezolizumab and bevacizumab in
advanced RCC. The study was designed to inform further
clinical development of this combination, and these study
results reinforce the potential of the combination in this
setting.
Patients whose disease expressed programmed cell
death ligand 1 (PD-L1) and were treated with atezolizumab
plus bevacizumab had a 36% reduction in the risk of the
disease worsening or death compared to people treated
with sunitinib alone (median progression-free survival =
14.7 vs 7.8 months; hazard ratio HR = 0.64; 95% confidence
interval CI = 0.38–1.08). No progression-free
survival advantage was observed compared to sunitinib in
the intention-to-treat population (median = 11.7 vs 8.4
months; HR = 1.00; 95% CI = 0.69–1.45).
Median duration of response has not yet been reached
after 20.7 months of follow-up across treatment arms.
Adverse events in the atezolizumab-plus-bevacizumab arm
were consistent with those observed in previous studies of
each drug.
First-line Pazopanib May Improve
Outcomes in Advanced RCC
PFS among patients with intermediate-risk advanced
clear-cell renal cell carcinoma (aCCRCC) is significantly
longer with pazopanib than temsirolimus as first-line therapy,
according to the findings of a randomized phase II
clinical trial presented at the 2018 Genitourinary Cancers
Symposium. Pazopanib therapy also appeared to elicit a
better objective response rate (ORR). Median PFS, the
study’s primary end point, was 5.2 months (95% CI 3.6–7.4)
for pazopanib compared with 2.6 months (95% CI 1.9–4.2)
for temsirolimus, Nizar M. Tannir, MD, and colleagues at the
University of Texas Health Science Center at Houston reported.
Among patients with intermediate-risk disease as
defined by International Metastatic Renal Cell Carcinoma
Database Consortium (IMDC) criteria, pazopanib was associated
with a significant 62% decreased risk of progression
compared with temsirolimus The median overall survival
was 12 months (95% CI 8.3–20.1) for the pazopanib group
and 7.4 months (95% CI 5.3–17.4) for the temsirolimus
group. The study found no significant difference between
the drugs among patients in the IMDC poor-risk group.
Phase 3 Trial Design Outlined for Lenvatinib
in Combination with Everolimus or
Pembrolizumab vs Sunitinib
Investigators reviewed the design of a multicenter,
open-label, phase 3 trial of lenvatinib plus everolimus or
pembrolizumab vs sunitinib as first-line treatment for
advanced RCC. Patients will be randomized 1:1:1 to receive
LEN 18 mg/d + EVE 5 mg/d, LEN 20 mg/d + PEM 200 mg
every 3 weeks, or SUN 50 mg/d (on a schedule of 4 weeks
on treatment followed by 2 weeks off) until disease progression,
unacceptable toxicity, withdrawal of consent, or study
end. Enrollment of 735 patients is planned.
The primary endpoint is to assess superiority of LEN+EVE
or LEN+PEM over single-agent SUN as first-line treatment
for advanced RCC in improving progression-free survival
(PFS) The secondary endpoints: comparison of objective
response rate (ORR), overall survival, PFS on next-line therapy,
health-related quality of life, and safety and tolerability
in pts receiving LEN+EVE or LEN+PEM vs SUN.
Exploratory endpoints: PFS in the LEN+PEM arm using
immune-related RECIST, comparison of duration of
response, disease control rate, and clinical benefit rate in pts
treated with LEN+EVE or LEN+PEM vs SUN, and analysis of
the relationship between blood biomarkers and outcome. KCJ