1. ESMO 2016 Nivolumab Data Study Ph Indication Line N Arms 1o EP ORR mDR
DCR
mPFS (mo)
PFS rate
mOS (mo)
OS rate
CheckMate 026 LBA7_PR
III
Rec. or Met. NSCLC
1st
541 All
211 PD–L1 ≥5%
212 PD–L1 ≥5%
IC PT-DC q3wk x6 cycles
PFS
5.9
13.2
53.6 (1-yr)
Neoadjuvant NSCLC
LBA41_PR II
Operable NSCLC
NAT
18 Evaluable
N3 q2wk x 1 mo—> surgery
Safety
39%
94%*
checkmate 275
LBA31_PR
mUCC
≧2nd
265 All***
143 PD-L1 <1%
122 PD-L1 ≥1%
184 PD-L1 <5%
81 PD-L1 ≥5%
N3 q2wk
19.6
16.1
23.8
15.8
28.4 NR
42.3
33.6
52.5
24.9
17.4
2.00
8.74
5.95
11.30
OpACIN
LBA39 Ib
Stage IIIB/C Melanoma
AT / NAT
20 All
17 Evaluable
8 AT
9 NAT+AT
Sx ➝ I3+N1 q3wk x4 or
I3+N1 q3wk x2 ➝ Sx ➝ I3+N1 q3wk x2
Tolerability
78%
89%
CheckMate O
I/II
adv. HCC
≧1st
48 Escalation
11 SorTx0
37 SorTx1
214 Expansion
69 SorTx0
145 SorTx1
N3 ND
15%
16% NC
68% NC
(6, 9, 12 mo)
66.0, 66.0, 59.1
63.6, 63.6, 63.6
66.7, 66.7, 57.6
82.5, 70.8, NC
88.1, 72.3, NC
80.2, 71.8, NC
Treatments Legend: I3 = ipilimumab 3 mg/kg; IC = investigator’s choice; N0.1 = nivolumab 0.1 mg/kg; N1 = nivolumab 1 mg/kg; N3 = nivolumab 3 mg/kg; N10 = nivolumab 10 mg/kg; PT-DC = platinum-based doublet chemotherapy; Sx = Surgery. Abbreviations: 1o EP = Primary Endpoint; adv. = advanced; AT = Adjuvant Treatment; DCR = Disease Control Rate; HCC = hepatocellular carcinoma; mDR = median Duration Response; met. = metastatic mOS = median Overall Survival; Mo = Months; mPFS = median Progression Free Survival; MPR = Major Pathological Response (<10% tumour left); mUCC = metastatic urothelial cell carcinoma; NAT = Neoadjuvant Treatment; NC = Not Calculated; ND = Not Documented; NR = Not Reached; NSCLC = non-small cell lung cancer; ORR = Overall Response Rate; OS = Overall Survival; PFS = Progression Free Survival; Ph = Phase; PLB = Placebo; PI = Principal Investigator; qXwk = every X weeks; rec. = recurrent; SQ-NSCLC = squamous NSCLC; SorTx0 = Sorafenib Naïve; SorTx1 = Sorafenib pre-treated; UNK = Unknown; wk = week; yr = year.
*LBA41_PR was a neoadjuvant study. Under ORR, the Major Pathological Responses are reported. Under DCR, the percentage of patients with evidence of tumour regression are reported.
** 3 out of 4 patients tested for PD-L1 expression and achieving a Major Pathological Response tested positive for PD-L1 expression (28-8 assay). 3 out of 6 patients had no radiographic evidence of response
*** At time median 7.0 months follow-up 49 patients were not evaluable (28 in PD-L1 <1%, 21 in PD-L1 ≥1% , 35 in PD-L1 <5%, and 14 in PD-L1 ≥5% subgroups)

2. ESMO 2016 Nivolumab Data Study Ph Indication Line N Arms 1o EP ORR mDR
DCR
mPFS (Mo)
PFS rate
mOS (Mo)
OS rate
CaboNivo Trial
774PD I
mUCC
≧2nd 24
RP2D: Cabo40 qd + N3 q2wk
Safety
33%
72%
CheckMate PD
III
Adv. SQ-NSCLC
2nd
135
137
N3 q2wk
T75 q3wk OS
20%
9%
3.5
2.8
NR (2-yr)
6.0
8% (2-yr)
CheckMate PD
Adv. NS-NSCLC
290
19%
12%
2.3
4.3
12%
1%
9.5
16% (2-yr)
Treatments Legend: Cabo40 = cabozantinib 40mg; N3 = nivolumab 3 mg/kg; T75 = docetaxel 75 mg/m2. Abbreviations: 1o EP = Primary Endpoint; adv. = advanced; DCR = Disease Control Rate; mDR = median Duration Response; mOS = median Overall Survival; mo = months; mPFS = median Progression Free Survival; mUCC = metastatic urothelial cell carcinoma; NR = Not Reached; NSCLC = non-small cell lung cancer; NS-NSCLC = Non-squamous NSCLC; ORR = Overall Response Rate; OS= Overall Survival; PFS = Progression Free Survival; Ph = Phase; qd = once daily; qXwk = every X weeks; RP2D = recommended phase II dose; SQ-NSCLC = squamous NSCLC; yr = year.