iii sessione “i risultati clinici” - progetto...
TRANSCRIPT
ImmunotherapyhastraditionallyplayedaroleinmRCC
1. McDermott D, et al. Cancer 2009;115(Suppl. 10):2298‒2305
2. Fyfe G. et al. J Clin Oncol.1995;13:688‒696
CytokinetherapyinmRCC
§ TreatmentwithIFN-α andIL-2
havebothshownclinicalactivity
inmRCC1
§ DurableresponsestoIL-2(ORR:14%
with5%CRand9%PR)butassociated
withsubstantialtoxicity2
Responsedurationinall responderstoIL-2treatment
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.00 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36
MonthsPe
rcen
t in
res
pons
e
Complete responsePartial response
FDAapproval in1992
Randomized DoseRanging SingleAgent Nivolumab inRCC(n=168)
Motzer RJ et al, J Clin Oncol 2015 May 1;33(13): 1430-7
Dose 0.3mg/kg 2mg/kg 10mg/kgIVq3wN=60
IVq3wN=54
IVq3wN=54
PriorRx 70%>2priortherapiesNoRxnaivepts
ORR(%) 20% 22% 20%mPFSPrimaryendpoint
2.7mo 4.0mo 4.2mo
mOS 18.2 25.5 24.7G3/4Tox 5% 17% 13%
§ Primaryendpoint§ Overallsurvival(OS)
§ Secondaryendpointsincluded§ Objectiveresponserate(ORR)§ Progression-freesurvival(PFS)§ Adverseevents§ Qualityoflife(QoL)§ OSbyPD-L1expression
Studyendpoints
§ Nivolumabèilprimoagenteingradodiaumentarel’OSnelmRCCpost-TKI
§ Nivolumabpracticechanging
§ Favorevoleprofiloditollerabilità
§ PD-L1statusprognosticomanonpredittivodirisposta
§ Ongoingstudidiimmunoterapiainprimalinea(Atezolizumab+bevacizumab,
Nivolumab+ipilimumab)
Conclusioni
Summary on PD-1 and PDL-1 inhibition in 2nd line bladder cancer
Presented By Peter Albers at 2015 ASCO Annual Meeting
Comparison PD-1/PDL-1 inhibition to Eribulin in 2nd line bladder cancer
Presented By Peter Albers at 2015 ASCO Annual Meeting
Fase Target Farmaco Comparator Linea EndPointII
PD-L1Atezolizumab
Nessuno2
ORRIII CHT PFSIII MEDI4736* CHT 1 PFSII
PD-1Nivolumab Nessuno 2 PFS
III Pembrolizumab CHT 2 PFSII CTLA-4 Ipilimumab** Nessuno 1 1-yOS
*± Tramelimumab
**+Cisplatino-Gemcitabina
ONGOING TRIALS WITH IMMUNOTHERAPIES