ESMO Madrid, Spain Associate Professor Brian Costello Division of Medical Oncology, Genitourinary Tumour Group, Mayo Clinic, USA
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2 ESMO Madrid, Spain Associate Professor Brian Costello Division of Medical Oncology, Genitourinary Tumour Group, Mayo Clinic, USA HIGHLIGHTS ON RENAL CELL CARCINOMA
3 CHECKMATE 214: EFFICACY AND SAFETY OF NIVOLUMAB + IPILIMUMAB V SUNITINIB FOR TREATMENT-NAÏVE ADVANCED OR mrcc, INCLUDING IMDC RISK AND PD-L1 EXPRESSION SUBGROUPS Escudier B et al. LBA5. ESMO Madrid 2017
4 CHECKMATE 214 Efficacy and safety of nivolumab + ipilimumab vs sunitinib for treatmentnaïve advanced or metastatic renal cell carcinoma (mrcc) Inclusion: Measurable clear cell histology KPS > 70 Available tumor tissue No prior treatment Randomized 1:1 Escudier B et al. LBA5. ESMO Madrid 2017
5 CHECKMATE 214 Treatment arm 1: Nivolumab 3 mg/kg IV + ipilimumab 1 mg/kg IV Every 3 weeks for 4 cycles Then nivolumab 3 mg/kg IV every 2 weeks Treatment arm 2: Sunitinib 50 mg orally 4 weeks on, 2 weeks off Co-primary endpoints (intermediate/poor risk) Overall response rate Progression free survival Overall survival Escudier B et al. LBA5. ESMO Madrid 2017
6 CHECKMATE 214 Results: 1096 randomized (nivo/ipi 550; sunitinib 546) Planned interim analysis Overall response rate Nivo/ipi: 42% Sunitinib: 27% Median progression free survival (did not reach statistical significance) Nivo/ipi: 11.6 months Sunitinib: 8.4 months Overall survival Nivo/ipi: 2 year OS 67%, median OS not reached Sunitinib: median OS 26.0 months Escudier B et al. LBA5. ESMO Madrid 2017
7 CHECKMATE 214 Conclusions: Statistically significant benefit from nivo/ipi in intermediate/poor risk patients 37% reduction in risk of death Improved overall response rate with nivo/ipi Tumor PD-L1 > 1% Higher overall response rate with nivo/ipi Improved progression free survival Safety profile consistent with previous studies Look for this combination to move toward regulatory approval in the future Escudier B et al. LBA5. ESMO Madrid 2017
8 SPAZO2 (SOGUG): COMPARATIVE EFFECTIVENESS OF PAZOPANIB IN METASTATIC RENAL CARCINOMA (MRC): INELIGIBLE (I) VS ELIGIBLE (E) PATIENTS FOR CLINICAL TRIALS J. Arranz Arija et al. 884P. ESMO Madrid 2017
9 SPAZO2 Comparative effectiveness of pazopanib in metastatic renal carcinoma; ineligible vs eligible patients for clinical trails Population: 530 patients treated with pazopanib off-study Patients evaluated using standard clinical trial criteria 217 patients would have been ineligible for a clinical trial Results: Compared to clinical trial eligible patients, ineligible patients had: Lower response rates Shorter progression free and overall survival Safety similar J. Arranz Arija et al. 884P. ESMO Madrid 2017
10 SPAZO2 Conclusions: Real-world eligible patients had similar outcomes to those in clinical trials Real-world ineligible patients had poorer outcomes Study highlights the challenges of applying clinical trial data to real world practice J. Arranz Arija et al. 884P. ESMO Madrid 2017
11 EFFICACY AND SAFETY DATA IN ELDERLY PATIENTS WITH mrcc INCLUDED IN THE NIVOLUMAB EXPANDED ACCESS PROGRAM (EAP) IN ITALY Sabbatini R et al. 897P. ESMO Madrid 2017
12 EFFICACY AND SAFETY DATA IN ELDERLY PATIENTS WITH mrcc INCLUDED IN THE NIVOLUMAB EXPANDED ACCESS PROGRAM IN ITALY Patients: At least 1 prior treatment Total of all ages = 389 > 70 years (elderly) = 125 Results for elderly patients: Disease control rate = 58% 6-month OS = 87.2% 12-month OS = 77.8% Safety profile consistent with observations in general population Sabbatini R et al. 897P. ESMO Madrid 2017
13 EFFICACY AND SAFETY DATA IN ELDERLY PATIENTS WITH mrcc INCLUDED IN THE NIVOLUMAB EXPANDED ACCESS PROGRAM IN ITALY Conclusions: Elderly patients benefit from nivolumab Safety is similar to the general population Data supports use of nivolumab for mrcc in the elderly population Sabbatini R et al. 897P. ESMO Madrid 2017
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