1. ESMO 2016 Durvalumab Data Study / Abstract Ph Indication Line N Arms
1o EP
ORR
DCR
mPFS (mo)
PFS rate
mOS (mo)
OS rate
Durvalumab
949O
I/II
(Subgroup of Solid Tumours)
≧1st
62 All
D10 q2wk
DLT & AE
11%
42% (1-yr)
1216PD
(Subgroup of Solid Tumours)
304 ALL
154 TC TC-
1st line
49 TC TC-
2nd line
46 TC TC-
≧3rd line
59 TC TC-
D10 q2wk up to 12 months NR
27% 6%
29%
26% 4%
22%
17.8 (1-yr, N=52)
8.2 (1-yr, N=27)
13.0 (1-yr, N=66)
7.1 (1-yr, N=84)
Durvalumab + MEDI0680
1050PD I
adv. Solid Tumors
≧2nd
30 All
4 Cohort_1
5 Cohort_2
3 Cohort_3
3 Cohort_4
9 Cohort_5
6 Cohort_6
MTD: NR
D3 q2wk + MEDI_0.1
D10 q2wk + MEDI_0.1
D10 q2wk + MEDI_0.5
D10 q2wk + MEDI_2.5
D10 q2wk + MEDI_10
D10 q2wk + MEDI_20 0% 0%
Treatments: D3 = Durvalumab 10 mg/kg; D10 = Durvalumab 10 mg/kg; MEDI_0.1 = MEDI mg/kg ; MEDI_0.5 = MEDI mg/kg; MEDI_2.5 = MEDI mg/kg; MEDI_10 = MEDI mg/kg; MEDI_20 = MEDI mg/kg; Abbreviations: 1o EP = Primary Endpoint; adv. = advanced; AE= Adverse Events; DCR = Disease Control Rate (SD + PR +CR); DLT = Dose Limiting Toxicity; met. = metastatic; mOS = median Overall Survival; mo = months; mPFS = median Progression Free Survival; NR= Not Reached/Reported; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate (PR + CR); OS = Overall Survival; PFS = Progression Free Survival; Ph = Phase; qXwk = every X weeks; rec. = recurrent; SCCHN = Head and Neck Squamous Cell Carcinoma; TC+ = Tumour Cell-positive for PD-L1 expression; TC- = Tumour Cell-negative for PD-L1 expression; yr = year.

2. ESMO 2016 Avelumab & Tremelimumab Data
Study / Abstract Ph
Indication
Line N
Arms
1o EP
ORR
DCR
mPFS
PFS rate
mOS (mo)
OS rate
Avelumab + Axitinib
775PD Ib
(Clear cell)
1st 6
RP2D: A10 q2wk + Axi5 BID
MTD & RP2D
83.3%
100%
Avelumab
777PD
mUCC
≧1st
(109 ≥ 4 mo FUP)
A10 q2wk
DLT & ORR
16.5%
36%
6.1 wk
35.6% (12-wk)
Tremelimumab + Gefitinib
1245P I
NSCLC
Subgroup
T3 q12wk +G250
Safety & tolerability 0%
67%
Treatments: A10 = Avelumab 10mg/kg; Axi5 = Axitinib 5mg; G250 = Gefitinib 250 mg; T3 = Tremelimumab 3 mg/kg. Abbreviations: 1o EP = Primary Endpoint; adv. = advanced; DCR = Disease Control Rate (SD + PR +CR); DLT = Dose-limiting Toxicity; EGFRmu+ = Carrier of EGFR mutation; FUP = Follow-Up; mOS = median Overall Survival; mo = months; mPFS = median Progression Free Survival; MTD = Maximum Tolerable Dose; mUCC = metastatic Urothelial Cell Carcinoma; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate (PR + CR); OS = Overall Survival; PFS = Progression Free Survival; Ph = Phase; qXwk = every X weeks; RCC = Renal Cell Carcinoma; RP2D = Recommended Phase 2 Dose; wk = weeks.