PracticeUpdate: Haematology & Oncology

EUROPEAN SOCIETY OF MEDICAL ONCOLOGY 2016 CONGRESS 22

Dr Brad Somer discusses key ESMO 2016 abstracts on renal cell carcinoma

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.

Bradley G Somer MD is Assistant Professor of Hematology/ Oncology at the University of Tennessee Health Science Center in Tennessee.

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

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

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