1. ASCO 2016 Pembrolizumab Data - Melanoma
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
Keynote-001 1b
Adv. Melanoma
≧ 1st
162
313
180
Pembro 10 q2wk
DLT, ORR & AE
25.9
(24, 36-Mo)
149 Tnai
All Arms Pembro 2 or 10 q3wk or Pembro 10 q2wk
32.0
(24, 36-Mo)
Keynote-006
III BMa
1st & 2nd
667 PDL1+
150 PDL1–
550 1st-line
284 2nd-line
PDL1+, TNai
Pembro 10 q2wk or q3wk x 24mo
Ipi 3 q3wk x 4
Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo
PFS & OS
39%
13%
25%
40%
29%
12%
43%
51% (6-Mo)
25% (6-Mo)
32% (6-Mo)
28% (6-Mo)
52% (6-Mo)
38% (6-Mo)
23% (6-Mo)
55% (6-Mo)
87% (6-Mo)
74% (6-Mo)
81% (6-Mo)
73% (6-Mo)
76% (6-Mo)
83% (6-Mo)
71% (6-Mo)
88% (6-Mo)
75% (6-Mo)
III
834
Ipi 3mg/kg q3wk x 4 or PD
13.3%
2.8
31.2% (24-Mo)
27.8% (24-Mo)
13.5% (24-Mo)
NR
NR
16.0
55.1% (24-Mo)
55.3% (24-Mo)
43.0% (24-Mo)
Keynote-029 I
153
Followed by Pembro 2 q3wk
PFS & AE
57% (Inv.)
2071 NA
with BM
10 (uBM)
Pembro (dose ND)
1.2
All: 86% (6-Mo)
MASTERKEY-265
Adv./Met. Melanoma
1st 21
T-VEC q2wk + Pembro 200 q2wk
PFS, OS & DLT
48%
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2. ASCO 2016 Pembrolizumab Data - NSCLC
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
Keynote 1b
Adv. NSCLC
≧ 1st
79 TPS 1-24% Tnai 306 TPS 1-24% PT 52 TPS 25-49% Tnai 168 TPS 25-49% PT 27 TPS ≥ 50% Tnai 138 TPS ≥ 50% PT 12 TPS < 1% Tnai
90 TPS < 1% PT
All Arms
Pembro 2 or 10 q3wk or
Pembro 10 q2wk
DLT, ORR & AE
19.5
8.2 NR
15.4
14.7
8.6
19 Sq. Tnai 76 Sq. PT
79 Non-Sq. Tnai
367 Non-Sq. PT
90 Smoker Tnai
324 Smoker PT
11 Non-Smoker Tnai
125 Non-Smoker PT
335 EGFRwt PT
74 EGFRmu PT
15.6
26.3
9.4
22.0
12.2
7.6
335 74
Keynote-010
III BMa
≧ 3rd
324 TPS 1-24% 147 TPS 1-24% 76 TPS 25-49% 44 TPS 25-49% 106 TPS 50-74% 52 TPS 50-74% 184 TPS ≥ 75% 100 TPS ≥ 75%
Pembro 2 q3wk or 10 q2wk x 24mo
Doce x 24mo or PD Pembro 2 q3wk or 10 q2wk x 24mo
Doce x 24mo or PD
PFS, OS & AE
8.6%
10.9%
15.8%
9.1%
22.6%
9.6%
33.7%
7.0%
2.6
4.3
4.0
9.7
8.5
9.9
15.8
10.6
Adv. NSCLC & TPS ≥1%
≧ 2nd
449
DLT, RR & AE
10.6
(18, 24-Mo)
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3. ASCO 2016 Pembrolizumab Data - Other
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
SARC-028 II
Adv. STS or BS
≧ 2nd
10 LMS
9 LPS
9 UPS
10 SS
19 OS
13 ES
6 CS
Pembro 200 q3wk NR
22%
5.2%
50% (8-wk)
63% (8-wk)
67% (8-wk)
30% (8-wk)
24% (8-wk)
9% (8-wk)
Keynote-055
HNSCC
≧ 3rd
172
ORR & AE
18%
4130
met. Pancreatic Carcinoma 23
ACP Pembro 200 q3wk
DLT
35%
3539
pMMR met. Colorectal Cancer 26
Ablation —> Pembro 200 q3wk
9% (ITM)
Keynote-087
C3) ASCT—>KN087 30
Pembro 200 q3wk
C3) NR
8517
rec. Thymic Carcinoma 21
24%
Keynote
Keynote
BMa
Rec./Met. HNSCC
≧ 2nd
TC PDL1-
TC PDL1+
TCIC PDL1-
TCIC PDL1+
TCIC PDL2-
TCIC PDL2+
HPV+
HPV-
Pembro 10 q2wk (n=60) or Pembro 200 q3wk (n=132) x 24mo
18.5% 17.9%
5.6%
21.1%
9.8%
22.5%
21.9%
15.9%
Keynote
Keynote
Keynote
Keynote
Keynote Ib
Salivary Gland Ca
Thyroid Ca
Sq. Cervical Cancer
Adv. Endometrial Ca
Adv. Esophageal Ca
After SOC 22 24 23
Pembro 10 q2wk x 24mo
28 wk BOR
11.5%
9.1%
12.5%
13.0%
30.4%
13% (6-Mo)
19% (6-Mo)
66.7% (6-Mo)
68.8% (6-Mo)
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4. ASCO 2016 Pembrolizumab Data - Legend
Treatments: ACP-196 = acalabrutinib 100 mg PO BID; Bev = bevacizumab 15 mg/kg; BM = Brain Metastasis; C = carboplatin AUC 6; Doce = Docetaxel 75 mg/kg2; Ipi 1 = Ipilimumab 1 mg/kg; Ipi 3 = Ipilimumab 3 mg/kg; P = paclitaxel 200 mg/m2; PEM = Pemetrexed 500 mg/m2; Pembro 200 = Pembro 200 mg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; RT = Radiotherapy; T-VEC = Talimogene laherparepvec ≤ 4 mL in (sub)cutaneous/nodal lesions, 106 PFU/mL d1, 108PFU/mL d22 then Q2W. Abbreviations: 28 wk BOR = Best Overall Response at 28 weeks; Adv. = Advanced; AE = Adverse Event; ASCT = Autologues Stem Cell Transplant; BV = Brentuximab Vedotin; C1, C2, BMa = Biomarker Study; BM = Brain Metastasis; C3 = Cohort 1, Cohort 2, Cohort 3; CS = high-grade/dedifferentiated chondrosarcoma; Ca = Carcinoma; DLT = Dose-Limiting Toxicity; EP = Endpoint; ES = Ewing sarcoma; HNSCC = Head and Neck Squamous Carcinoma; IDMC = Independent Data Monitoring Committee; Inv = Investigator; IPI = ipilimumab; ITM = Interim; LMS = leiomyosarcoma; LPS = liposarcoma; mDR = median Duration Response; met. = Metastatic; Mo = Month; mOS = median Overall Survival; mPFS = median Progression Free Survival; mTTR = median Time to Recurrence; NA = Not Applicable; ND = Not Disclosed; NR = Not Reached; ORR = Overall Response Rate; OS = Overall Survival; OSt = osteosarcoma; PDL1- = Negative for PD-Ligand 1 expression; PDL1+ = Positive for PD-Ligand 1 expression; PDL2- = Negative for PD-Ligand 2 expression; PDL2+ = Positive for PD-Ligand 2 expression; PFS = Progression Free Survival; Ph = Phase; pMMR= Mismatch Repair proficient; PT = Previously Treated; rec. = Recurrent; R/R cHL = Refractory / Recurrent Classical Hodgkin Lymphoma; SOC = Standard of Care; SQ = Squamous Histology; SS = synovial sarcoma; tBM = treated Brain Metastasis;TC= Tumor Cells; TCIC=Tumor Cells and Inflammatory Cells; Tnai = Treatment Naive; TPS = Tumor Proportion Score PD-L1 Expression; TTP = Time to Progression; uBM = untreated Brain Metastasis; UPS = undifferentiated pleomorphic sarcoma; wk = Week
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5. ASCO 2016 Pembrolizumab Data - Melanoma
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
Keynote-001 1b
Adv. Melanoma
≧ 1st
162
313
180
Pembro 10 q2wk
DLT, ORR & AE
25.9
(24, 36-Mo)
149 Tnai
All Arms Pembro 2 or 10 q3wk or Pembro 10 q2wk
32.0
(24, 36-Mo)
Keynote-006
III BMa
1st & 2nd
667 PDL1+
150 PDL1–
550 1st-line
284 2nd-line
PDL1+, TNai
Pembro 10 q2wk or q3wk x 24mo
Ipi 3 q3wk x 4
Ipi 3 q3wk x 4 Pembro 10 q2wk or q3wk x 24mo
PFS & OS
39%
13%
25%
40%
29%
12%
43%
51% (6-Mo)
25% (6-Mo)
32% (6-Mo)
28% (6-Mo)
52% (6-Mo)
38% (6-Mo)
23% (6-Mo)
55% (6-Mo)
87% (6-Mo)
74% (6-Mo)
81% (6-Mo)
73% (6-Mo)
76% (6-Mo)
83% (6-Mo)
71% (6-Mo)
88% (6-Mo)
75% (6-Mo)
III
834
Ipi 3mg/kg q3wk x 4 or PD
13.3%
2.8
31.2% (24-Mo)
27.8% (24-Mo)
13.5% (24-Mo)
NR
NR
16.0
55.1% (24-Mo)
55.3% (24-Mo)
43.0% (24-Mo)
Keynote-029 I
153
Followed by Pembro 2 q3wk
PFS & AE
57% (Inv.)
2071 NA
with BM
10 (uBM)
Pembro (dose ND)
1.2
All: 86% (6-Mo)
MASTERKEY-265
Adv./Met. Melanoma
1st 21
T-VEC q2wk + Pembro 200 q2wk
PFS, OS & DLT
48%
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6. ASCO 2016 Pembrolizumab Data - NSCLC
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
Keynote 1b
Adv. NSCLC
≧ 1st
79 TPS 1-24% Tnai 306 TPS 1-24% PT 52 TPS 25-49% Tnai 168 TPS 25-49% PT 27 TPS ≥ 50% Tnai 138 TPS ≥ 50% PT 12 TPS < 1% Tnai
90 TPS < 1% PT
All Arms
Pembro 2 or 10 q3wk or
Pembro 10 q2wk
DLT, ORR & AE
19.5
8.2 NR
15.4
14.7
8.6
19 Sq. Tnai 76 Sq. PT
79 Non-Sq. Tnai
367 Non-Sq. PT
90 Smoker Tnai
324 Smoker PT
11 Non-Smoker Tnai
125 Non-Smoker PT
335 EGFRwt PT
74 EGFRmu PT
15.6
26.3
9.4
22.0
12.2
7.6
335 74
Keynote-010
III BMa
≧ 3rd
324 TPS 1-24% 147 TPS 1-24% 76 TPS 25-49% 44 TPS 25-49% 106 TPS 50-74% 52 TPS 50-74% 184 TPS ≥ 75% 100 TPS ≥ 75%
Pembro 2 q3wk or 10 q2wk x 24mo
Doce x 24mo or PD Pembro 2 q3wk or 10 q2wk x 24mo
Doce x 24mo or PD
PFS, OS & AE
8.6%
10.9%
15.8%
9.1%
22.6%
9.6%
33.7%
7.0%
2.6
4.3
4.0
9.7
8.5
9.9
15.8
10.6
Adv. NSCLC & TPS ≥1%
≧ 2nd
449
DLT, RR & AE
10.6
(18, 24-Mo)
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7. ASCO 2016 Pembrolizumab Data - Other
Study / Abstract Ph
Indication
Line N
Arms
1o EP
TTP
ORR
(Mo)
PFS rate
(Mo)
OS rate
SARC-028 II
Adv. STS or BS
≧ 2nd
10 LMS
9 LPS
9 UPS
10 SS
19 OS
13 ES
6 CS
Pembro 200 q3wk NR
22%
5.2%
50% (8-wk)
63% (8-wk)
67% (8-wk)
30% (8-wk)
24% (8-wk)
9% (8-wk)
Keynote-055
HNSCC
≧ 3rd
172
ORR & AE
18%
4130
met. Pancreatic Carcinoma 23
ACP Pembro 200 q3wk
DLT
35%
3539
pMMR met. Colorectal Cancer 26
Ablation —> Pembro 200 q3wk
9% (ITM)
Keynote-087
C3) ASCT—>KN087 30
Pembro 200 q3wk
C3) NR
8517
rec. Thymic Carcinoma 21
24%
Keynote
Keynote
BMa
Rec./Met. HNSCC
≧ 2nd
TC PDL1-
TC PDL1+
TCIC PDL1-
TCIC PDL1+
TCIC PDL2-
TCIC PDL2+
HPV+
HPV-
Pembro 10 q2wk (n=60) or Pembro 200 q3wk (n=132) x 24mo
18.5% 17.9%
5.6%
21.1%
9.8%
22.5%
21.9%
15.9%
Keynote
Keynote
Keynote
Keynote
Keynote Ib
Salivary Gland Ca
Thyroid Ca
Sq. Cervical Cancer
Adv. Endometrial Ca
Adv. Esophageal Ca
After SOC 22 24 23
Pembro 10 q2wk x 24mo
28 wk BOR
11.5%
9.1%
12.5%
13.0%
30.4%
13% (6-Mo)
19% (6-Mo)
66.7% (6-Mo)
68.8% (6-Mo)
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8. ASCO 2016 Pembrolizumab Data - Legend
Treatments: ACP-196 = acalabrutinib 100 mg PO BID; Bev = bevacizumab 15 mg/kg; BM = Brain Metastasis; C = carboplatin AUC 6; Doce = Docetaxel 75 mg/kg2; Ipi 1 = Ipilimumab 1 mg/kg; Ipi 3 = Ipilimumab 3 mg/kg; P = paclitaxel 200 mg/m2; PEM = Pemetrexed 500 mg/m2; Pembro 200 = Pembro 200 mg; Pembro 2 = Pembro 2 mg/kg; Pembro 10 = Pembro 10 mg/kg; RT = Radiotherapy; T-VEC = Talimogene laherparepvec ≤ 4 mL in (sub)cutaneous/nodal lesions, 106 PFU/mL d1, 108PFU/mL d22 then Q2W. Abbreviations: 28 wk BOR = Best Overall Response at 28 weeks; Adv. = Advanced; AE = Adverse Event; ASCT = Autologues Stem Cell Transplant; BV = Brentuximab Vedotin; C1, C2, BMa = Biomarker Study; BM = Brain Metastasis; C3 = Cohort 1, Cohort 2, Cohort 3; CS = high-grade/dedifferentiated chondrosarcoma; Ca = Carcinoma; DLT = Dose-Limiting Toxicity; EP = Endpoint; ES = Ewing sarcoma; HNSCC = Head and Neck Squamous Carcinoma; IDMC = Independent Data Monitoring Committee; Inv = Investigator; IPI = ipilimumab; ITM = Interim; LMS = leiomyosarcoma; LPS = liposarcoma; mDR = median Duration Response; met. = Metastatic; Mo = Month; mOS = median Overall Survival; mPFS = median Progression Free Survival; mTTR = median Time to Recurrence; NA = Not Applicable; ND = Not Disclosed; NR = Not Reached; ORR = Overall Response Rate; OS = Overall Survival; OSt = osteosarcoma; PDL1- = Negative for PD-Ligand 1 expression; PDL1+ = Positive for PD-Ligand 1 expression; PDL2- = Negative for PD-Ligand 2 expression; PDL2+ = Positive for PD-Ligand 2 expression; PFS = Progression Free Survival; Ph = Phase; pMMR= Mismatch Repair proficient; PT = Previously Treated; rec. = Recurrent; R/R cHL = Refractory / Recurrent Classical Hodgkin Lymphoma; SOC = Standard of Care; SQ = Squamous Histology; SS = synovial sarcoma; tBM = treated Brain Metastasis;TC= Tumor Cells; TCIC=Tumor Cells and Inflammatory Cells; Tnai = Treatment Naive; TPS = Tumor Proportion Score PD-L1 Expression; TTP = Time to Progression; uBM = untreated Brain Metastasis; UPS = undifferentiated pleomorphic sarcoma; wk = Week
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