ESMO 2016 Durvalumab Data Study / Abstract Ph Indication Line N Arms

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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+ 115 TC- 1st line 49 TC+ 9 TC- 2nd line 46 TC+ 24 TC- ≧3rd line 59 TC+ 82 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 = MEDI0680 0.1 mg/kg ; MEDI_0.5 = MEDI0680 0.5 mg/kg; MEDI_2.5 = MEDI0680 2.5 mg/kg; MEDI_10 = MEDI0680 10mg/kg; MEDI_20 = MEDI0680 20mg/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.

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.