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Dr Brad Somer discusses key
ESMO 2016 abstracts on renal
cell carcinoma
Bradley G Somer MD is Assistant Professor of Hematology/
Oncology at the University of Tennessee Health Science Center
in Tennessee.
Abstract 1062P Updated results from a phase I study
of nivolumab (Nivo) in combination with ipilimumab
(Ipi) in metastatic renal cell carcinoma (mRCC): The
CheckMate 016 study.
H Hammers, ER Plimack,
JR Infante, et al
•
This study included a total of 94 patients with
metastatic RCC, with 47 patients randomised
to receive IV nivolumab 3 mg/kg + ipilimumab
1 mg/kg or nivolumab 1 mg/kg + ipilimumab
3 mg/kg. After a median follow-up of 22
months, the overall response rate was 40%
in each arm, with median PFS of 6.6 months
with nivolumab 3 + ipilimumab 1 and 9.1
months with nivolumab 1 + ipilimumab 3.
More frequent grade 3/4 treatment-related
adverse effects were reported with nivolumab
1 + ipilimumab 3 compared with nivolumab
3 + ipilimumab 1 (62% vs 38%). The most
common grade 3/4 effects were gastrointestinal
and hepatic.
•
Study results demonstrate manageable
safety and durable responses, correlating
with previous data of dose-related toxicity
of ipilimumab, supporting development of
nivolumab 3 + ipilimumab 1 as a first-line
therapy.
Abstract 773PD Axitinib in combination with
pembrolizumab in patients (pts) with advanced
renal cell carcinoma (aRCC): Preliminary safety and
efficacy results.
MB Atkins, ER Plimack, I Puzanov,
et al
•
This phase IB study enrolled 52 treatment-
naive patients with clear cell advanced renal
cell carcinoma (aRCC) who received axitinib
5 mg orally twice daily and pembrolizumab
2 mg/kg IV on day 1 of each 3-week cycle.
Of these patients, 11 discontinued both
treatments due to disease progression (n=4),
treatment-emergent adverse effects (n=6),
or other reasons (n=1). A total of 33 patients
had partial responses, and 2 had complete
responses, with 11 patients having stable
disease. Of 11 patients in the dose-finding
phase, 7 remained progression-free at 11
months. PD-L1 test results were positive in
10 patients. The most common grade 3 adverse
effects included hypertension, headache,
hyponatraemia, diarrhoea, increased ALT,
and increased AST; grade 4 adverse events
included hyperuricemia and dyspnea; and
immune-related adverse events included AST,
ALT, colitis, and diarrhoea.
•
This study demonstrates effective antitumour
activity and tolerability of combination axitinib
and pembrolizumab in treatment-naive patients
with aRCC.
Abstract 775PD Phase 1b dose-finding study of
avelumab (anti-PD-L1) + axitinib in treatment-naïve
patients with advanced renal cell carcinoma.
J Larkin, BI Rini, P Nathan, et al
•
Treatment-naive patients (n=6) with
histologically confirmed advanced RCC with
a clear-cell component received avelumab for a
median of 17 weeks and axitinib for 16.3 weeks
to determine the safety and tolerability of the
regimen as well as the maximum tolerated
dose. Common treatment-related adverse
effects included hypertension, dysphonia,
headache, and fatigue, with no patients
discontinuing treatment due to the effects.
Of the 6 patients, 5 had a confirmed partial
response, and 1 exhibited stable disease with
tumour shrinkage that did not meet partial
response.
•
The study results demonstrate the tolerability
and efficacy of avelumab plus axitinib in
treatment-naïve patients with advanced RCC.
Abstract LBA11_PR Phase III trial of sunitinib (SU)
vs placebo (PBO) as adjuvant treatment for high-
risk renal cell carcinoma (RCC) after nephrectomy
(S-TRAC).
A Ravaud, RJ Motzer, HS Pandha, et al
Abstract LBA30_PR CABOzantinib versus SUNitinib
(CABOSUN) as initial targeted therapy for patients
with metastatic renal cell carcinoma (mRCC) of
poor and intermediate risk groups: Results from
ALLIANCE A031203 trial.
TK Choueiri, S Halabi,
B Sanford, et al
ESMO 2016
7–11 OCTOBER 2016 •
COPENHAGEN, DENMARK
From the European
Society of Medical
Oncology Congress this
year, Dr Brad Somer
and Dr Toni Choueiri
share their picks of the
top trials in renal cell
carcinoma, Dr Arlene
Siefker-Radtke talks
about managing rare
histologies in bladder
cancer, and Dr Brian
Lewis shares his
top prostate cancer
abstracts.
© ESMO 2016
EUROPEAN SOCIETY OF MEDICAL ONCOLOGY 2016 CONGRESS
22
PRACTICEUPDATE HAEMATOLOGY & ONCOLOGY