Summary
Lung cancer is currently is the most common cause of death from cancer worldwide. Of total lung cancer incident cases, approximately 85% are the non-small cell lung cancer (NSCLC) subtype. NSCLC patients are usually diagnosed in the later stages of the disease, with poor prognosis. Historically, treatment options for advanced-stage NSCLC patients have been dominated by chemotherapy. However, the launch of targeted therapies such as Iressa (gefitinib) in 2003, Tarceva (erlotinib) in 2004, and Xalkori (crizotinib) in 2011, has shifted the treatment landscape towards personalized medicine.
In 2015, the NSCLC market in Japan was an estimated $981M. This growth is fueled by the increasing use of immunotherapies across histologies and lines of therapy in NSCLC. The use of PD-1 checkpoint inhibitors in first-line therapy of NSCLC is expected to take away significant sales from conventional chemotherapies that are typically used in the first line. The recent failure of Opdivo monotherapy in 5% or more of PD-L1+ patients in the first-line could further help Tecentriq’s sales, as Opdivo is a major presence in NSCLC in Japan.
*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.
Scope
- Overview of NSCLC including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting Japan NSCLC market.
Reasons to buy
- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for NSCLC.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2015-2025 in Japan.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 16
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 20
2.3 Upcoming Related Reports 21
3 Disease Overview 22
3.1 Etiology and Pathophysiology 22
3.1.1 Etiology 22
3.1.2 Pathophysiology 22
3.2 Classification or Staging Systems 26
3.3 Symptoms 29
3.4 Prognosis 30
3.5 Quality of Life 32
4 Disease Management 33
4.1 Diagnosis and Treatment Overview 33
4.1.1 Diagnosis 33
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 36
4.1.3 Clinical Practice 38
4.2 Japan 43
5 Competitive Assessment 44
5.1 Overview 44
5.2 Product Profiles - Major Brands, Epidermal Growth Factor Receptor-Targeting 46
5.2.1 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors 46
5.2.2 Tarceva (erlotinib hydrochloride) 50
5.2.3 Iressa (gefitinib) 61
5.2.4 Gilotrif (afatinib) 66
5.2.5 Tagrisso (osimertinib) 75
5.2.6 Portrazza (necitumumab) 81
5.2.7 Conmana (icotinib) 87
5.3 Product Profiles - Major Brands, Anaplastic Lymphoma Kinase-Targeting 93
5.3.1 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors 93
5.3.2 Xalkori (crizotinib) 95
5.3.3 Zykadia (ceritinib) 103
5.3.4 Alecensa (alectinib) 108
5.4 Product Profiles - Major Brands, Monoclonal Antibodies 114
5.4.1 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 114
5.4.2 Opdivo (nivolumab) 119
5.4.3 Keytruda (pembrolizumab) 126
5.4.4 Tecentriq (atezolizumab) 133
5.5 Product Profiles - Major Brands, Other 149
5.5.1 Avastin (bevacizumab) 149
5.5.2 Cyramza (ramucirumab) 155
5.5.3 Vargatef/Ofev (nintedanib) 160
5.6 Chemotherapies 164
6 Unmet Needs Assessment and Opportunity Analysis 166
6.1 Overview 166
6.2 First-Line Treatments That Extend Overall Survival in Advanced-Stage Nonsquamous NSCLC Without Actionable Mutations 168
6.2.1 Unmet Need 168
6.2.2 Gap Analysis 169
6.2.3 Opportunity 170
6.3 Therapies Targeting Novel Biomarkers 171
6.3.1 Unmet Need 171
6.3.2 Gap Analysis 172
6.3.3 Opportunity 174
6.4 Treatment Options for Squamous Patients in the First-Line and Third-Line Setting 175
6.4.1 Unmet Need 175
6.4.2 Gap Analysis 176
6.4.3 Opportunity 178
6.5 Alternative Testing Options for Patients with Insufficient Biopsy Material 180
6.5.1 Unmet Need 180
6.5.2 Gap Analysis 181
6.5.3 Opportunity 183
6.6 Treatments for Patients with Acquired Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Resistance 184
6.6.1 Unmet Need 184
6.6.2 Gap Analysis 185
6.6.3 Opportunity 187
7 Pipeline Assessment 189
7.1 Overview 189
7.2 Promising Drugs in Clinical Development 191
7.2.1 Immune Checkpoint Inhibitors 194
7.2.2 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors 238
7.2.3 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors 260
7.2.4 Therapeutic Cancer Vaccines 277
7.2.5 Anti-angiogenic Therapies 291
7.2.6 Avastin (bevacizumab) Biosimilars 306
7.2.7 KRAS Inhibitors 309
7.2.8 Tafinlar (dabrafenib) + Mekinist (trametinib) 319
7.2.9 Veliparib (ABT-888) 326
7.2.10 Seribantumab (MM-121) 336
7.2.11 IMMU-132 (sacituzumab govitecan) 342
7.2.12 Plinabulin (NPI-2358) 350
7.3 Promising Drugs in Early-Stage Development 356
7.3.1 Immune Checkpoint Inhibitors 357
7.3.2 Anaplastic Lymphoma Kinase Inhibitors 360
7.3.3 Neurotropic Tropomyosin-Related Kinase Inhibitors 361
7.3.4 MET inhibitors 364
7.3.5 Rearranged During Transfection Inhibitors 370
7.3.6 Human Epidermal Growth Factor 2 Inhibitors 375
7.3.7 PI3K Pathway Inhibitors 377
8 Market Outlook 380
8.1 Japan 380
8.1.1 Forecast 380
8.1.2 Key Events 382
8.1.3 Drivers and Barriers 383
9 Appendix 386
9.1 Bibliography 386
9.2 Abbreviations 432
9.3 Methodology 443
9.4 Forecasting Methodology 443
9.4.1 Diagnosed NSCLC Patients 443
9.4.2 Percent Drug-Treated Patients 444
9.4.3 Drugs Included in Each Therapeutic Class 444
9.4.4 Launch and Patent Expiry Dates 447
9.4.5 General Pricing Assumptions 449
9.4.6 Individual Drug Assumptions 451
9.4.7 Generic Erosion 465
9.4.8 Pricing of Pipeline Agents 465
9.5 Primary Research - KOLs 470
9.5.1 KOLs 470
9.6 About the Authors 474
9.6.1 Analyst 474
9.6.2 Therapy Area Director 474
9.6.3 Epidemiologist 475
9.6.4 Global Head of Healthcare 475
9.7 About GlobalData 477
9.8 Disclaimer 477
1.1 List of Tables
Table 1: Definitions Used in the AJCC Lung Cancer Staging System 27
Table 2: AJCC Staging of NSCLC 28
Table 3: Symptoms of NSCLC 30
Table 4: Prognostic Factors for NSCLC 31
Table 5: Prognosis for NSCLC Based on Initial Staging 31
Table 6: Prevalence of Brain and Bone Metastases in NSCLC 34
Table 7: Biomarker Testing Rates in Nonsquamous NSCLC 35
Table 8: Biomarker Testing Rates in Squamous NSCLC 36
Table 9: Treatment Guidelines for NSCLC 37
Table 10: Most Prescribed Drugs for NSCLC by Class in the 8MM, 2015-2025 37
Table 11: Country Profile - Japan 43
Table 12: Leading Treatments for NSCLC, 2016 45
Table 13: Marketed EGFR TKIs in NSCLC 47
Table 14: Product Profile - Tarceva 52
Table 15: Efficacy of Tarceva in First-Line Therapy, EGFR-mutant NSCLC 56
Table 16: Efficacy of Tarceva in Maintenance Therapy in NSCLC 57
Table 17: Efficacy of Tarceva in Second- and Third-Line Therapy in NSCLC 58
Table 18: Safety of Tarceva 59
Table 19: Tarceva SWOT Analysis, 2016 60
Table 20: Product Profile - Iressa 61
Table 21: Efficacy of Iressa in First-Line, EGFR-Mutant NSCLC (Study 1) 64
Table 22: Efficacy of Iressa in First-Line, EGFR-Mutant ADC NSCLC (Study 2) 64
Table 23: Safety of Iressa 65
Table 24: Iressa SWOT Analysis, 2016 66
Table 25: Product Profile - Gilotrif 68
Table 26: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 71
Table 27: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 72
Table 28: Efficacy of Gilotrif in Second-Line, EGFR-Wildtype, EGFR TKI-Naïve, Squamous NSCLC 72
Table 29: Efficacy of Gilotrif in Fourth-Line, EGFR-Mutant NSCLC 73
Table 30: Safety of Gilotrif 74
Table 31: Gilotrif SWOT Analysis, 2016 75
Table 32: Product Profile - Tagrisso 76
Table 33: Efficacy of Tagrisso in Second-Line, EGFR-Mutant NSCLC 79
Table 34: Safety of Tagrisso 80
Table 35: Tagrisso SWOT Analysis, 2016 81
Table 36: Product Profile - Portrazza 83
Table 37: Efficacy of Portrazza in First-Line, Squamous NSCLC 85
Table 38: Safety of Portrazza 86
Table 39: Portrazza SWOT Analysis, 2016 87
Table 40: Efficacy of Conmana in 2L Advanced NSCLC 90
Table 41: Efficacy of Conmana in 1L EGFR-mutant NSCLC 90
Table 42: Safety of Conmana 91
Table 43: Conmana SWOT Analysis, 2016 92
Table 44: Marketed ALK TKIs in NSCLC 93
Table 45: Product Profile - Xalkori 96
Table 46: Efficacy of Xalkori in Treatment-Naïve ALK+ Metastatic NSCLC 98
Table 47: Efficacy of Xalkori in Previously Treated ALK+ Metastatic NSCLC 99
Table 48: Safety of Xalkori in Treatment-Naïve, ALK+ Metastatic NSCLC 101
Table 49: Safety of Xalkori in Previously Treated, Metastatic NSCLC 102
Table 50: Xalkori SWOT Analysis, 2016 103
Table 51: Product Profile - Zykadia 104
Table 52: Efficacy of Zykadia 106
Table 53: Safety of Zykadia 107
Table 54: Zykadia SWOT Analysis, 2016 108
Table 55: Product Profile - Alecensa 109
Table 56: Efficacy of Alecensa 111
Table 57: Efficacy of Alecensa in NSCLC patients with CNS lesions 111
Table 58: Safety of Alecensa 113
Table 59: Alecensa SWOT Analysis, 2016 114
Table 60: Marketed PD-1/PD-L1 ICIs in NSCLC 115
Table 61: Product Profile - Opdivo 120
Table 62: Efficacy of Opdivo in Metastatic Squamous NSCLC 123
Table 63: Efficacy of Opdivo in Metastatic Nonsquamous NSCLC 124
Table 64: Safety of Opdivo 125
Table 65: Opdivo SWOT Analysis, 2016 126
Table 66: Product Profile - Keytruda 128
Table 67: Efficacy of Keytruda 131
Table 68: Safety of Keytruda 132
Table 69: Keytruda SWOT Analysis, 2016 133
Table 70: Product Profile - Tecentriq (atezolizumab) 135
Table 71: Patient Demographics in the Phase II POPLAR Trial (NCT01903993) 138
Table 72: Efficacy of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 140
Table 73: Efficacy of Tecentriq in the Phase III OAK Trial (NCT02008227) 141
Table 74: Patient Demographics in the Phase II FIR Trial (NCT01846416) 142
Table 75: Efficacy of Tecentriq in the Phase II FIR Trial (NCT01846416) 143
Table 76: Efficacy of Tecentriq in the Phase II BIRCH Trial (NCT02031458) 145
Table 77: Safety of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 146
Table 78: Safety of Tecentriq in the Phase II FIR Trial (NCT01846416) 147
Table 79: Tecentriq SWOT Analysis, 2016 148
Table 80: Product Profile - Avastin 150
Table 81: Efficacy of Avastin in Nonsquamous NSCLC 153
Table 82: Safety of Avastin 154
Table 83: Avastin SWOT Analysis, 2016 154
Table 84: Product Profile - Cyramza 156
Table 85: Efficacy of Cyramza 158
Table 86: Safety of Cyramza 159
Table 87: Cyramza SWOT Analysis, 2016 160
Table 88: Product Profile - Vargatef 161
Table 89: Efficacy of Vargatef in ADC NSCLC 162
Table 90: Safety of Vargatef in ADC NSCLC 163
Table 91: Vargatef SWOT Analysis, 2016 164
Table 92: Summary of Chemotherapies, 2015 165
Table 93: Unmet Need and Opportunity in NSCLC 168
Table 94: Product Profile - Yervoy (ipilimumab) 196
Table 95: Demographics in the Phase II NCT00527735 Trial 198
Table 96: Efficacy of Yervoy + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 200
Table 97: Demographics in the Phase I CheckMate 012 Trial (NCT01454102) 201
Table 98: Efficacy of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 202
Table 99: Safety of Yervoy (ipilimumab) + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 204
Table 100: Safety of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 205
Table 101: Yervoy SWOT Analysis, 2016 207
Table 102: Product Profile - Avelumab (MSB-0010718C) 210
Table 103: Patient Demographics in the Phase Ib Dose-Expansion Study (NCT01772004) 212
Table 104: Efficacy of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 213
Table 105: Efficacy of Avelumab in PD-L1-Positive and -Negative NSCLC 214
Table 106: Demographics in the Treatment-Naïve NSCLC Cohort in the Phase I Trial (NCT01772004) 215
Table 107: Efficacy of Avelumab in Treatment-Naïve NSCLC 216
Table 108: Unconfirmed ORR According to PD-L1 Expression in Treatment-Naïve NSCLC 217
Table 109: Safety of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 218
Table 110: Safety of Avelumab in Treatment-Naïve NSCLC (NCT01772004) 219
Table 111: Avelumab SWOT Analysis, 2016 221
Table 112: Product Profile - Durvalumab (MEDI4736) 223
Table 113: Patient Demographics and Disease Characteristics in the Phase I/II NCT01693562 Trial 226
Table 114: Efficacy of Durvalumab in the Phase I/II NCT01693562 Trial 227
Table 115: Baseline Characteristics of Patients With Treatment-Naïve NSCLC in the Phase I/II 228
Table 116: Efficacy of Durvalumab in Treatment-Naïve NSCLC 229
Table 117: Patient Demographics and Disease Characteristics in the Phase Ib NCT02000947 Trial 230
Table 118: Efficacy of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 232
Table 119: Safety of Durvalumab in the Phase I/II Trial (NCT01693562) 233
Table 120: Safety of Durvalumab in Treatment-Naïve NSCLC 234
Table 121: Safety of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 235
Table 122: Durvalumab SWOT Analysis, 2016 237
Table 123: Product Profile - Naquotinib Mesylate (ASP8273) 241
Table 124: Patient Demographics in the Phase I/II NCT02192697 and Phase I NCT02113813 Trials 242
Table 125: Efficacy of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 243
Table 126: Safety of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 244
Table 127: Naquotinib SWOT Analysis, 2016 245
Table 128: Product Profile - Olmutinib (BI 1482694; HM61713) 246
Table 129: Demographics in the Phase I/II NCT01588145 Trial 248
Table 130: Efficacy of Olmutinib in the Phase II Portion of the NCT01588145 Trial 249
Table 131: Safety Profile of Olmutinib in the Phase II Portion of the NCT01588145 Trial 250
Table 132: Olmutinib SWOT Analysis, 2016 251
Table 133: Product Profile - Dacomitinib 253
Table 134: Demographics in the Phase II NCT00818441 Trial 255
Table 135: Efficacy of Dacomitinib in the Phase II NCT00818441 Trial 256
Table 136: Safety of Dacomitinib in Phase II NCT00818441 Trial 258
Table 137: Dacomitinib SWOT Analysis, 2016 259
Table 138: Product Profile - Ensartinib 262
Table 139: Baseline Patient Characteristics in the Phase I/II eXalt2 Trial (NCT0162534) 263
Table 140: Efficacy of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 264
Table 141: Baseline Patient Characteristics in the Expansion Cohort of the Phase I/II eXalt2 Trial 265
Table 142: Efficacy of Ensartinib in the Expansion Phase of the eXalt2 Trial (NCT0162534) 266
Table 143: Safety of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 267
Table 144: Ensartinib SWOT Analysis, 2016 268
Table 145: Product Profile - Brigatinib 270
Table 146: Baseline Patient Characteristics in the Phase II ALTA Trial (NCT02094573) 272
Table 147: Efficacy of Brigatinib in the Phase II ALTA Trial (NCT02094573) 273
Table 148: Efficacy of Brigatinib in ALK+ NSCLC with Intracranial CNS Metastases 274
Table 149: Safety of Brigatinib in the Phase II ALTA Trial (NCT02094573) 275
Table 150: Brigatinib SWOT Analysis, 2016 276
Table 151: Product Profile - CimaVax-EGF 279
Table 152: Demographics in the Phase III trial of the CimaVax-EGF in Cuba 281
Table 153: Efficacy of the CimaVax-EGF in the Phase III trial in Cuba 282
Table 154: Safety of the CimaVax-EGF in the Phase III Trial in Cuba 283
Table 155: CimaVax-EGF SWOT Analysis, 2016 285
Table 156: Product Profile - Tedopi 287
Table 157: Demographics in the Phase II Trial of Tedopi in Advanced NSCLC 288
Table 158: Efficacy of Tedopi in Advanced NSCLC 289
Table 159: Tedopi SWOT Analysis, 2016 291
Table 160: Product Profile - Anlotinib 293
Table 161: Efficacy of Anlotinib in Pretreated NSCLC in the Phase II ALTER0302 Trial 294
Table 162: Anlotinib SWOT Analysis, 2016 295
Table 163: Product Profile - Aitan 297
Table 164: Efficacy of Aitan in Pretreated Nonsquamous NSCLC 298
Table 165: Aitan SWOT Analysis, 2016 299
Table 166: Product Profile - Fruquintinib 301
Table 167: Baseline Demographics in the Phase I Trial (HMP, NCT01645215) of Fruquintinib 302
Table 168: Efficacy of Fruquintinib in Advanced Solid Tumors 303
Table 169: Safety of Fruquintinib in Advanced Solid Tumors 304
Table 170: Fruquintinib SWOT Analysis, 2016 305
Table 171: Efficacy and Safety of ABP 215 in NSCLC in the Phase III Trial (NCT01966003) 308
Table 172: Product Profile - Abemaciclib 312
Table 173: Efficacy of Abemaciclib Monotherapy in Previously Treated NSCLC (NCT01394016) 314
Table 174: Efficacy of Abemaciclib in Combination with Other Therapies (NCT02079636) 315
Table 175: Safety of Abemaciclib in Combination with Multiple Single Agents 316
Table 176: Abemaciclib SWOT Analysis, 2016 318
Table 177: Product Profile - Tafinlar + Mekinist 320
Table 178: Demographics in Cohort B of the Pivotal Phase II BRF113928 Trial (GSK, NCT01336634) 322
Table 179: Efficacy of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 323
Table 180: Safety of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 324
Table 181: Tafinlar + Mekinist SWOT Analysis, 2016 326
Table 182: Product Profile - Veliparib 328
Table 183: Demographics in the Phase II NCT01560104 Trial 330
Table 184: Efficacy of VCP in Advanced NSCLC (NCT01560104) 331
Table 185: Efficacy of VCP by Smoking Status (NCT01560104) 332
Table 186: Safety of VCP in Advanced NSCLC (NCT01560104) 333
Table 187: Veliparib SWOT Analysis, 2016 335
Table 188: Product Profile - Seribantumab (MM-121) 337
Table 189: Demographics in Group A of the Phase I/II Trial (NCT00994123) of MM-121 + Tarceva in 338
Table 190: Efficacy of MM-121 + Tarceva in EGFR Wild-Type NSCLC 339
Table 191: Safety of MM-121 + Tarceva in EGFR Wild-Type NSCLC 340
Table 192: MM-121 SWOT Analysis, 2016 341
Table 193: Product Profile - Sacituzumab govitecan (IMMU-132) 343
Table 194: Demographics in the Phase II Portion of the Phase I/II Trial (NCT01631552) 345
Table 195: Efficacy of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552) 346
Table 196: Efficacy of IMMU-132 in Patients Who Progressed on Prior Checkpoint Inhibitor 347
Table 197: Safety of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552) 348
Table 198: IMMU-132 SWOT Analysis, 2016 349
Table 199: Product Profile - Plinabulin 351
Table 200: Efficacy of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110) 353
Table 201: Safety of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110) 353
Table 202: Plinabulin SWOT Analysis, 2016 355
Table 203: Early-Stage Clinical Development in NSCLC 357
Table 204: MET Status in the Phase II (NCT01610336) Trial 366
Table 205: Efficacy of Capmatinib + Iressa in MET+ NSCLC 367
Table 206: Demographics in the Phase II LURET Study 372
Table 207: Efficacy of Caprelsa in RET+ NSCLC 372
Table 208: Demographics in the Stage I of the Phase II NCT01639508 Trial 374
Table 209: Efficacy of Cometriq in RET+ NSCLC 375
Table 210: Key Events Impacting Sales for NSCLC in Japan, 2016 382
Table 211: NSCLC -Drivers and Barriers in Japan, 2015‒2025 383
Table 212: Key Launch Dates - Part I 447
Table 213: Key Launch Dates - Part II 448
Table 214: Key Patent Expiries 449
Table 215 Average Body Weight and Surface Area Across the 8MM 450
Table 216: Average Cost of Therapy of Alimta in the 8MM 452
Table 217: Average Cost of Therapy of Alecensa in the 8MM 453
Table 218: Average Cost of Therapy of Avastin 454
Table 219: Average Cost of Therapy of Cyramza 454
Table 220: Average Cost of Therapy of Gilotrif 455
Table 221: Average Cost of Therapy of Iressa 456
Table 222: Average Cost of Therapy of Portrazza 457
Table 223: Average Cost of Therapy of Tagrisso 458
Table 224: Average Cost of Therapy of Tarceva 459
Table 225: Average Cost of Therapy of Vargatef 459
Table 226: Average Cost of Therapy of Xalkori 460
Table 227: Average Cost of Therapy of Zykadia 461
Table 228: Average Cost of Therapy of Keytruda 462
Table 229: Average Cost of Therapy of Opdivo 463
Table 230: Average Cost of Therapy of Tecentriq 464
Table 231: Average Cost of Therapy of Conmana 465
Table 232: High-Prescribing Physicians Surveyed by Country 473
1.2 List of Figures
Figure 1: Disease Management Flowchart for nonsquamous NSCLC 39
Figure 2: Disease Management Flowchart for squamous NSCLC 40
Figure 3: Disease Management Flowchart for EGFR+ NSCLC 41
Figure 4: Disease Management Flowchart for ALK+ NSCLC 42
Figure 5: Tarceva’s Phase III Development in NSCLC 53
Figure 6: Iressa’s Phase II Development in NSCLC 62
Figure 7: Gilotrif’s Phase III Development in NSCLC 70
Figure 8: Tagrisso’s Phase III Development in NSCLC 77
Figure 9: Portrazza’s Phase II Development in NSCLC 84
Figure 10: Conmana’s Phase III Development in NSCLC 89
Figure 11: Xalkori’s Development in NSCLC 97
Figure 12: Zykadia’s Development in NSCLC 105
Figure 13: Alecensa’s Development in NSCLC 110
Figure 14: Opdivo’s Development in NSCLC 122
Figure 15: Keytruda’s Phase III Development in NSCLC 130
Figure 16: Tecentriq’s Clincal Development in NSCLC 137
Figure 17: Avastin’s Phase III Development in NSCLC 151
Figure 18: Cyramza’s Phase III Development in NSCLC 157
Figure 19: Vargatef’s Phase II Development in NSCLC 162
Figure 20: NSCLC - Phase II/III Pipeline, 2016, Part I 191
Figure 21: NSCLC - Phase II/III Pipeline, 2016, Part II 192
Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2015-2025 193
Figure 23: Yervoy’s Clinical Development in NSCLC 197
Figure 24: Clinical and Commercial Positioning of Yervoy 206
Figure 25: Estimated Sales of Ipilimumab Biosimilars Versus Branded Yervoy in NSCLC, 2015-2025 208
Figure 26: Avelumab’s Development in NSCLC 211
Figure 27: Clinical and Commercial Positioning of Avelumab 220
Figure 28: Durvalumab’s Clinical Development in NSCLC 224
Figure 29: Clinical and Commercial Positioning of Durvalumab 236
Figure 30: Naquotinib’s Clincal Development in NSCLC 241
Figure 31: Clinical and Commercial Positioning of Naquotinib 244
Figure 32: Olmutinib’s Clincal Development in NSCLC 247
Figure 33: Clinical and Commercial Positioning of Olmutinib 250
Figure 34: Dacomitinib’s Clinical Development in NSCLC 253
Figure 35: Clinical and Commercial Positioning of Dacomitinib 259
Figure 36: Ensartinib’s Clinical Development in NSCLC 262
Figure 37: Clinical and Commercial Positioning of Ensartinib 267
Figure 38: Brigatinib’s Clinical Development in NSCLC 271
Figure 39: Clinical and Commercial Positioning of Brigatinib 276
Figure 40: CimaVax-EGF’s Clinical Development in NSCLC 280
Figure 41: Clinical and Commercial Positioning of CimaVax-EGF 284
Figure 42: Tedopi’s Clinical Development in NSCLC 287
Figure 43: Clinical and Commercial Positioning of Tedopi 290
Figure 44: Anlotinib’s Clinical Development in NSCLC 293
Figure 45: Clinical and Commercial Positioning of Anlotinib 295
Figure 46: Aitan’s Clinical Development in NSCLC 297
Figure 47: Clinical and Commercial Positioning of Aitan 299
Figure 48: Fruquintinib’s Clinical Development in NSCLC 301
Figure 49: Clinical and Commercial Positioning of Fruquintinib 305
Figure 50: Clinical Development of Avastin Biosimilars in NSCLC 307
Figure 51: Estimated Sales of Bevacizumab Biosimilars Versus Branded Avastin in NSCLC, 2015-2025 309
Figure 52: Abemaciclib’s Clinical Development in NSCLC 313
Figure 53: Clinical and Commercial Positioning of Abemaciclib 317
Figure 54: Tafinlar + Mekinist’s Clinical Development in NSCLC 321
Figure 55: Clinical and Commercial Positioning of Tafinlar + Mekinist 325
Figure 56: Veliparib’s Clinical Development in NSCLC 329
Figure 57: Clinical and Commercial Positioning of Veliparib 334
Figure 58: MM-121’s Clinical Development in NSCLC 337
Figure 59: Clinical and Commercial Positioning of MM-121 341
Figure 60: IMMU-132’s Clinical Development in NSCLC 344
Figure 61: Clinical and Commercial Positioning of IMMU-132 349
Figure 62: Plinabulin’s Clinical Development in NSCLC 352
Figure 63: Clinical and Commercial Positioning of Plinabulin 354
Figure 64: Sales for NSCLC in Japan, 2015-2025 381
