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.
As a drug class, immunotherapeutics are projected to contribute the most to the US market expansion. As a result, both these drug classes are expected to take patient share away from branded chemotherapy, a class that will contract as a whole at a negative CAGR of 18.4%. The growth of the IO drug class will be 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.
*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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 the US.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 16
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 19
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 21
3.2 Classification or Staging Systems 25
3.3 Symptoms 28
3.4 Prognosis 29
3.5 Quality of Life 31
4 Disease Management 32
4.1 Diagnosis and Treatment Overview 32
4.1.1 Diagnosis 32
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 35
4.1.3 Clinical Practice 37
4.2 US 42
5 Competitive Assessment 43
5.1 Overview 43
5.2 Product Profiles - Major Brands, Epidermal Growth Factor Receptor-Targeting 45
5.2.1 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors 45
5.2.2 Tarceva (erlotinib hydrochloride) 49
5.2.3 Iressa (gefitinib) 60
5.2.4 Gilotrif (afatinib) 65
5.2.5 Tagrisso (osimertinib) 74
5.2.6 Portrazza (necitumumab) 80
5.2.7 Conmana (icotinib) 86
5.3 Product Profiles - Major Brands, Anaplastic Lymphoma Kinase-Targeting 92
5.3.1 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors 92
5.3.2 Xalkori (crizotinib) 94
5.3.3 Zykadia (ceritinib) 102
5.3.4 Alecensa (alectinib) 107
5.4 Product Profiles - Major Brands, Monoclonal Antibodies 113
5.4.1 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 113
5.4.2 Opdivo (nivolumab) 118
5.4.3 Keytruda (pembrolizumab) 125
5.4.4 Tecentriq (atezolizumab) 132
5.5 Product Profiles - Major Brands, Other 148
5.5.1 Avastin (bevacizumab) 148
5.5.2 Cyramza (ramucirumab) 154
5.5.3 Vargatef/Ofev (nintedanib) 159
5.6 Chemotherapies 163
6 Unmet Needs Assessment and Opportunity Analysis 165
6.1 Overview 165
6.2 First-Line Treatments That Extend Overall Survival in Advanced-Stage Nonsquamous NSCLC Without Actionable Mutations 167
6.2.1 Unmet Need 167
6.2.2 Gap Analysis 168
6.2.3 Opportunity 169
6.3 Therapies Targeting Novel Biomarkers 170
6.3.1 Unmet Need 170
6.3.2 Gap Analysis 171
6.3.3 Opportunity 173
6.4 Treatment Options for Squamous Patients in the First-Line and Third-Line Setting 174
6.4.1 Unmet Need 174
6.4.2 Gap Analysis 175
6.4.3 Opportunity 177
6.5 Alternative Testing Options for Patients with Insufficient Biopsy Material 179
6.5.1 Unmet Need 179
6.5.2 Gap Analysis 180
6.5.3 Opportunity 182
6.6 Treatments for Patients with Acquired Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Resistance 183
6.6.1 Unmet Need 183
6.6.2 Gap Analysis 184
6.6.3 Opportunity 186
7 Pipeline Assessment 188
7.1 Overview 188
7.2 Promising Drugs in Clinical Development 190
7.2.1 Immune Checkpoint Inhibitors 193
7.2.2 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors 237
7.2.3 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors 259
7.2.4 Therapeutic Cancer Vaccines 276
7.2.5 Anti-angiogenic Therapies 290
7.2.6 Avastin (bevacizumab) Biosimilars 305
7.2.7 KRAS Inhibitors 308
7.2.8 Tafinlar (dabrafenib) + Mekinist (trametinib) 318
7.2.9 Veliparib (ABT-888) 325
7.2.10 Seribantumab (MM-121) 335
7.2.11 IMMU-132 (sacituzumab govitecan) 341
7.2.12 Plinabulin (NPI-2358) 349
7.3 Promising Drugs in Early-Stage Development 355
7.3.1 Immune Checkpoint Inhibitors 356
7.3.2 Anaplastic Lymphoma Kinase Inhibitors 359
7.3.3 Neurotropic Tropomyosin-Related Kinase Inhibitors 360
7.3.4 MET inhibitors 363
7.3.5 Rearranged During Transfection Inhibitors 369
7.3.6 Human Epidermal Growth Factor 2 Inhibitors 374
7.3.7 PI3K Pathway Inhibitors 376
8 Market Outlook 379
8.1 US 379
8.1.1 Forecast 379
8.1.2 Key Events 382
8.1.3 Drivers and Barriers 384
9 Appendix 387
9.1 Bibliography 387
9.2 Abbreviations 433
9.3 Methodology 444
9.4 Forecasting Methodology 444
9.4.1 Diagnosed NSCLC Patients 444
9.4.2 Percent Drug-Treated Patients 445
9.4.3 Drugs Included in Each Therapeutic Class 445
9.4.4 Launch and Patent Expiry Dates 448
9.4.5 General Pricing Assumptions 450
9.4.6 Individual Drug Assumptions 452
9.4.7 Generic Erosion 466
9.4.8 Pricing of Pipeline Agents 466
9.5 Primary Research - KOLs 471
9.5.1 KOLs 471
9.6 About the Authors 475
9.6.1 Analyst 475
9.6.2 Therapy Area Director 475
9.6.3 Epidemiologist 476
9.6.4 Global Head of Healthcare 476
9.7 About GlobalData 478
9.8 Disclaimer 478
1.1 List of Tables
Table 1: Definitions Used in the AJCC Lung Cancer Staging System 26
Table 2: AJCC Staging of NSCLC 27
Table 3: Symptoms of NSCLC 29
Table 4: Prognostic Factors for NSCLC 30
Table 5: Prognosis for NSCLC Based on Initial Staging 30
Table 6: Prevalence of Brain and Bone Metastases in NSCLC 33
Table 7: Biomarker Testing Rates in Nonsquamous NSCLC 34
Table 8: Biomarker Testing Rates in Squamous NSCLC 35
Table 9: Treatment Guidelines for NSCLC 36
Table 10: Most Prescribed Drugs for NSCLC by Class in the 8MM, 2015-2025 36
Table 11: Country Profile - US 42
Table 12: Leading Treatments for NSCLC, 2016 44
Table 13: Marketed EGFR TKIs in NSCLC 46
Table 14: Product Profile - Tarceva 51
Table 15: Efficacy of Tarceva in First-Line Therapy, EGFR-mutant NSCLC 55
Table 16: Efficacy of Tarceva in Maintenance Therapy in NSCLC 56
Table 17: Efficacy of Tarceva in Second- and Third-Line Therapy in NSCLC 57
Table 18: Safety of Tarceva 58
Table 19: Tarceva SWOT Analysis, 2016 59
Table 20: Product Profile - Iressa 60
Table 21: Efficacy of Iressa in First-Line, EGFR-Mutant NSCLC (Study 1) 63
Table 22: Efficacy of Iressa in First-Line, EGFR-Mutant ADC NSCLC (Study 2) 63
Table 23: Safety of Iressa 64
Table 24: Iressa SWOT Analysis, 2016 65
Table 25: Product Profile - Gilotrif 67
Table 26: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 70
Table 27: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 71
Table 28: Efficacy of Gilotrif in Second-Line, EGFR-Wildtype, EGFR TKI-Naïve, Squamous NSCLC 71
Table 29: Efficacy of Gilotrif in Fourth-Line, EGFR-Mutant NSCLC 72
Table 30: Safety of Gilotrif 73
Table 31: Gilotrif SWOT Analysis, 2016 74
Table 32: Product Profile - Tagrisso 75
Table 33: Efficacy of Tagrisso in Second-Line, EGFR-Mutant NSCLC 78
Table 34: Safety of Tagrisso 79
Table 35: Tagrisso SWOT Analysis, 2016 80
Table 36: Product Profile - Portrazza 82
Table 37: Efficacy of Portrazza in First-Line, Squamous NSCLC 84
Table 38: Safety of Portrazza 85
Table 39: Portrazza SWOT Analysis, 2016 86
Table 40: Efficacy of Conmana in 2L Advanced NSCLC 89
Table 41: Efficacy of Conmana in 1L EGFR-mutant NSCLC 89
Table 42: Safety of Conmana 90
Table 43: Conmana SWOT Analysis, 2016 91
Table 44: Marketed ALK TKIs in NSCLC 92
Table 45: Product Profile - Xalkori 95
Table 46: Efficacy of Xalkori in Treatment-Naïve ALK+ Metastatic NSCLC 97
Table 47: Efficacy of Xalkori in Previously Treated ALK+ Metastatic NSCLC 98
Table 48: Safety of Xalkori in Treatment-Naïve, ALK+ Metastatic NSCLC 100
Table 49: Safety of Xalkori in Previously Treated, Metastatic NSCLC 101
Table 50: Xalkori SWOT Analysis, 2016 102
Table 51: Product Profile - Zykadia 103
Table 52: Efficacy of Zykadia 105
Table 53: Safety of Zykadia 106
Table 54: Zykadia SWOT Analysis, 2016 107
Table 55: Product Profile - Alecensa 108
Table 56: Efficacy of Alecensa 110
Table 57: Efficacy of Alecensa in NSCLC patients with CNS lesions 110
Table 58: Safety of Alecensa 112
Table 59: Alecensa SWOT Analysis, 2016 113
Table 60: Marketed PD-1/PD-L1 ICIs in NSCLC 114
Table 61: Product Profile - Opdivo 119
Table 62: Efficacy of Opdivo in Metastatic Squamous NSCLC 122
Table 63: Efficacy of Opdivo in Metastatic Nonsquamous NSCLC 123
Table 64: Safety of Opdivo 124
Table 65: Opdivo SWOT Analysis, 2016 125
Table 66: Product Profile - Keytruda 127
Table 67: Efficacy of Keytruda 130
Table 68: Safety of Keytruda 131
Table 69: Keytruda SWOT Analysis, 2016 132
Table 70: Product Profile - Tecentriq (atezolizumab) 134
Table 71: Patient Demographics in the Phase II POPLAR Trial (NCT01903993) 137
Table 72: Efficacy of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 139
Table 73: Efficacy of Tecentriq in the Phase III OAK Trial (NCT02008227) 140
Table 74: Patient Demographics in the Phase II FIR Trial (NCT01846416) 141
Table 75: Efficacy of Tecentriq in the Phase II FIR Trial (NCT01846416) 142
Table 76: Efficacy of Tecentriq in the Phase II BIRCH Trial (NCT02031458) 144
Table 77: Safety of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 145
Table 78: Safety of Tecentriq in the Phase II FIR Trial (NCT01846416) 146
Table 79: Tecentriq SWOT Analysis, 2016 147
Table 80: Product Profile - Avastin 149
Table 81: Efficacy of Avastin in Nonsquamous NSCLC 152
Table 82: Safety of Avastin 153
Table 83: Avastin SWOT Analysis, 2016 153
Table 84: Product Profile - Cyramza 155
Table 85: Efficacy of Cyramza 157
Table 86: Safety of Cyramza 158
Table 87: Cyramza SWOT Analysis, 2016 159
Table 88: Product Profile - Vargatef 160
Table 89: Efficacy of Vargatef in ADC NSCLC 161
Table 90: Safety of Vargatef in ADC NSCLC 162
Table 91: Vargatef SWOT Analysis, 2016 163
Table 92: Summary of Chemotherapies, 2015 164
Table 93: Unmet Need and Opportunity in NSCLC 167
Table 94: Product Profile - Yervoy (ipilimumab) 195
Table 95: Demographics in the Phase II NCT00527735 Trial 197
Table 96: Efficacy of Yervoy + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 199
Table 97: Demographics in the Phase I CheckMate 012 Trial (NCT01454102) 200
Table 98: Efficacy of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 201
Table 99: Safety of Yervoy (ipilimumab) + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 203
Table 100: Safety of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 204
Table 101: Yervoy SWOT Analysis, 2016 206
Table 102: Product Profile - Avelumab (MSB-0010718C) 209
Table 103: Patient Demographics in the Phase Ib Dose-Expansion Study (NCT01772004) 211
Table 104: Efficacy of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 212
Table 105: Efficacy of Avelumab in PD-L1-Positive and -Negative NSCLC 213
Table 106: Demographics in the Treatment-Naïve NSCLC Cohort in the Phase I Trial (NCT01772004) 214
Table 107: Efficacy of Avelumab in Treatment-Naïve NSCLC 215
Table 108: Unconfirmed ORR According to PD-L1 Expression in Treatment-Naïve NSCLC 216
Table 109: Safety of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 217
Table 110: Safety of Avelumab in Treatment-Naïve NSCLC (NCT01772004) 218
Table 111: Avelumab SWOT Analysis, 2016 220
Table 112: Product Profile - Durvalumab (MEDI4736) 222
Table 113: Patient Demographics and Disease Characteristics in the Phase I/II NCT01693562 Trial 225
Table 114: Efficacy of Durvalumab in the Phase I/II NCT01693562 Trial 226
Table 115: Baseline Characteristics of Patients With Treatment-Naïve NSCLC in the Phase I/II 227
Table 116: Efficacy of Durvalumab in Treatment-Naïve NSCLC 228
Table 117: Patient Demographics and Disease Characteristics in the Phase Ib NCT02000947 Trial 229
Table 118: Efficacy of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 231
Table 119: Safety of Durvalumab in the Phase I/II Trial (NCT01693562) 232
Table 120: Safety of Durvalumab in Treatment-Naïve NSCLC 233
Table 121: Safety of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 234
Table 122: Durvalumab SWOT Analysis, 2016 236
Table 123: Product Profile - Naquotinib Mesylate (ASP8273) 240
Table 124: Patient Demographics in the Phase I/II NCT02192697 and Phase I NCT02113813 Trials 241
Table 125: Efficacy of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 242
Table 126: Safety of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 243
Table 127: Naquotinib SWOT Analysis, 2016 244
Table 128: Product Profile - Olmutinib (BI 1482694; HM61713) 245
Table 129: Demographics in the Phase I/II NCT01588145 Trial 247
Table 130: Efficacy of Olmutinib in the Phase II Portion of the NCT01588145 Trial 248
Table 131: Safety Profile of Olmutinib in the Phase II Portion of the NCT01588145 Trial 249
Table 132: Olmutinib SWOT Analysis, 2016 250
Table 133: Product Profile - Dacomitinib 252
Table 134: Demographics in the Phase II NCT00818441 Trial 254
Table 135: Efficacy of Dacomitinib in the Phase II NCT00818441 Trial 255
Table 136: Safety of Dacomitinib in Phase II NCT00818441 Trial 257
Table 137: Dacomitinib SWOT Analysis, 2016 258
Table 138: Product Profile - Ensartinib 261
Table 139: Baseline Patient Characteristics in the Phase I/II eXalt2 Trial (NCT0162534) 262
Table 140: Efficacy of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 263
Table 141: Baseline Patient Characteristics in the Expansion Cohort of the Phase I/II eXalt2 Trial 264
Table 142: Efficacy of Ensartinib in the Expansion Phase of the eXalt2 Trial (NCT0162534) 265
Table 143: Safety of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 266
Table 144: Ensartinib SWOT Analysis, 2016 267
Table 145: Product Profile - Brigatinib 269
Table 146: Baseline Patient Characteristics in the Phase II ALTA Trial (NCT02094573) 271
Table 147: Efficacy of Brigatinib in the Phase II ALTA Trial (NCT02094573) 272
Table 148: Efficacy of Brigatinib in ALK+ NSCLC with Intracranial CNS Metastases 273
Table 149: Safety of Brigatinib in the Phase II ALTA Trial (NCT02094573) 274
Table 150: Brigatinib SWOT Analysis, 2016 275
Table 151: Product Profile - CimaVax-EGF 278
Table 152: Demographics in the Phase III trial of the CimaVax-EGF in Cuba 280
Table 153: Efficacy of the CimaVax-EGF in the Phase III trial in Cuba 281
Table 154: Safety of the CimaVax-EGF in the Phase III Trial in Cuba 282
Table 155: CimaVax-EGF SWOT Analysis, 2016 284
Table 156: Product Profile - Tedopi 286
Table 157: Demographics in the Phase II Trial of Tedopi in Advanced NSCLC 287
Table 158: Efficacy of Tedopi in Advanced NSCLC 288
Table 159: Tedopi SWOT Analysis, 2016 290
Table 160: Product Profile - Anlotinib 292
Table 161: Efficacy of Anlotinib in Pretreated NSCLC in the Phase II ALTER0302 Trial 293
Table 162: Anlotinib SWOT Analysis, 2016 294
Table 163: Product Profile - Aitan 296
Table 164: Efficacy of Aitan in Pretreated Nonsquamous NSCLC 297
Table 165: Aitan SWOT Analysis, 2016 298
Table 166: Product Profile - Fruquintinib 300
Table 167: Baseline Demographics in the Phase I Trial (HMP, NCT01645215) of Fruquintinib 301
Table 168: Efficacy of Fruquintinib in Advanced Solid Tumors 302
Table 169: Safety of Fruquintinib in Advanced Solid Tumors 303
Table 170: Fruquintinib SWOT Analysis, 2016 304
Table 171: Efficacy and Safety of ABP 215 in NSCLC in the Phase III Trial (NCT01966003) 307
Table 172: Product Profile - Abemaciclib 311
Table 173: Efficacy of Abemaciclib Monotherapy in Previously Treated NSCLC (NCT01394016) 313
Table 174: Efficacy of Abemaciclib in Combination with Other Therapies (NCT02079636) 314
Table 175: Safety of Abemaciclib in Combination with Multiple Single Agents 315
Table 176: Abemaciclib SWOT Analysis, 2016 317
Table 177: Product Profile - Tafinlar + Mekinist 319
Table 178: Demographics in Cohort B of the Pivotal Phase II BRF113928 Trial (GSK, NCT01336634) 321
Table 179: Efficacy of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 322
Table 180: Safety of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 323
Table 181: Tafinlar + Mekinist SWOT Analysis, 2016 325
Table 182: Product Profile - Veliparib 327
Table 183: Demographics in the Phase II NCT01560104 Trial 329
Table 184: Efficacy of VCP in Advanced NSCLC (NCT01560104) 330
Table 185: Efficacy of VCP by Smoking Status (NCT01560104) 331
Table 186: Safety of VCP in Advanced NSCLC (NCT01560104) 332
Table 187: Veliparib SWOT Analysis, 2016 334
Table 188: Product Profile - Seribantumab (MM-121) 336
Table 189: Demographics in Group A of the Phase I/II Trial (NCT00994123) of MM-121 + Tarceva in 337
Table 190: Efficacy of MM-121 + Tarceva in EGFR Wild-Type NSCLC 338
Table 191: Safety of MM-121 + Tarceva in EGFR Wild-Type NSCLC 339
Table 192: MM-121 SWOT Analysis, 2016 340
Table 193: Product Profile - Sacituzumab govitecan (IMMU-132) 342
Table 194: Demographics in the Phase II Portion of the Phase I/II Trial (NCT01631552) 344
Table 195: Efficacy of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552) 345
Table 196: Efficacy of IMMU-132 in Patients Who Progressed on Prior Checkpoint Inhibitor 346
Table 197: Safety of IMMU-132 in Pretreated NSCLC in the Phase I/II Trial (NCT01631552) 347
Table 198: IMMU-132 SWOT Analysis, 2016 348
Table 199: Product Profile - Plinabulin 350
Table 200: Efficacy of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110) 352
Table 201: Safety of Plinabulin + Docetaxel in the Phase I/II Trial (NCT00630110) 352
Table 202: Plinabulin SWOT Analysis, 2016 354
Table 203: Early-Stage Clinical Development in NSCLC 356
Table 204: MET Status in the Phase II (NCT01610336) Trial 365
Table 205: Efficacy of Capmatinib + Iressa in MET+ NSCLC 366
Table 206: Demographics in the Phase II LURET Study 371
Table 207: Efficacy of Caprelsa in RET+ NSCLC 371
Table 208: Demographics in the Stage I of the Phase II NCT01639508 Trial 373
Table 209: Efficacy of Cometriq in RET+ NSCLC 374
Table 210: Key Events Impacting Sales for NSCLC in the US, 2016 382
Table 211: NSCLC -Drivers and Barriers in the US, 2015‒2025 384
Table 212: Key Launch Dates - Part I 448
Table 213: Key Launch Dates - Part II 449
Table 214: Key Patent Expiries 450
Table 215 Average Body Weight and Surface Area Across the 8MM 451
Table 216: Average Cost of Therapy of Alimta in the 8MM 453
Table 217: Average Cost of Therapy of Alecensa in the 8MM 454
Table 218: Average Cost of Therapy of Avastin 455
Table 219: Average Cost of Therapy of Cyramza 455
Table 220: Average Cost of Therapy of Gilotrif 456
Table 221: Average Cost of Therapy of Iressa 457
Table 222: Average Cost of Therapy of Portrazza 458
Table 223: Average Cost of Therapy of Tagrisso 459
Table 224: Average Cost of Therapy of Tarceva 460
Table 225: Average Cost of Therapy of Vargatef 460
Table 226: Average Cost of Therapy of Xalkori 461
Table 227: Average Cost of Therapy of Zykadia 462
Table 228: Average Cost of Therapy of Keytruda 463
Table 229: Average Cost of Therapy of Opdivo 464
Table 230: Average Cost of Therapy of Tecentriq 465
Table 231: Average Cost of Therapy of Conmana 466
Table 232: High-Prescribing Physicians Surveyed by Country 474
1.2 List of Figures
Figure 1: Disease Management Flowchart for nonsquamous NSCLC 38
Figure 2: Disease Management Flowchart for squamous NSCLC 39
Figure 3: Disease Management Flowchart for EGFR+ NSCLC 40
Figure 4: Disease Management Flowchart for ALK+ NSCLC 41
Figure 5: Tarceva’s Phase III Development in NSCLC 52
Figure 6: Iressa’s Phase II Development in NSCLC 61
Figure 7: Gilotrif’s Phase III Development in NSCLC 69
Figure 8: Tagrisso’s Phase III Development in NSCLC 76
Figure 9: Portrazza’s Phase II Development in NSCLC 83
Figure 10: Conmana’s Phase III Development in NSCLC 88
Figure 11: Xalkori’s Development in NSCLC 96
Figure 12: Zykadia’s Development in NSCLC 104
Figure 13: Alecensa’s Development in NSCLC 109
Figure 14: Opdivo’s Development in NSCLC 121
Figure 15: Keytruda’s Phase III Development in NSCLC 129
Figure 16: Tecentriq’s Clincal Development in NSCLC 136
Figure 17: Avastin’s Phase III Development in NSCLC 150
Figure 18: Cyramza’s Phase III Development in NSCLC 156
Figure 19: Vargatef’s Phase II Development in NSCLC 161
Figure 20: NSCLC - Phase II/III Pipeline, 2016, Part I 190
Figure 21: NSCLC - Phase II/III Pipeline, 2016, Part II 191
Figure 22: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2015-2025 192
Figure 23: Yervoy’s Clinical Development in NSCLC 196
Figure 24: Clinical and Commercial Positioning of Yervoy 205
Figure 25: Estimated Sales of Ipilimumab Biosimilars Versus Branded Yervoy in NSCLC, 2015-2025 207
Figure 26: Avelumab’s Development in NSCLC 210
Figure 27: Clinical and Commercial Positioning of Avelumab 219
Figure 28: Durvalumab’s Clinical Development in NSCLC 223
Figure 29: Clinical and Commercial Positioning of Durvalumab 235
Figure 30: Naquotinib’s Clincal Development in NSCLC 240
Figure 31: Clinical and Commercial Positioning of Naquotinib 243
Figure 32: Olmutinib’s Clincal Development in NSCLC 246
Figure 33: Clinical and Commercial Positioning of Olmutinib 249
Figure 34: Dacomitinib’s Clinical Development in NSCLC 252
Figure 35: Clinical and Commercial Positioning of Dacomitinib 258
Figure 36: Ensartinib’s Clinical Development in NSCLC 261
Figure 37: Clinical and Commercial Positioning of Ensartinib 266
Figure 38: Brigatinib’s Clinical Development in NSCLC 270
Figure 39: Clinical and Commercial Positioning of Brigatinib 275
Figure 40: CimaVax-EGF’s Clinical Development in NSCLC 279
Figure 41: Clinical and Commercial Positioning of CimaVax-EGF 283
Figure 42: Tedopi’s Clinical Development in NSCLC 286
Figure 43: Clinical and Commercial Positioning of Tedopi 289
Figure 44: Anlotinib’s Clinical Development in NSCLC 292
Figure 45: Clinical and Commercial Positioning of Anlotinib 294
Figure 46: Aitan’s Clinical Development in NSCLC 296
Figure 47: Clinical and Commercial Positioning of Aitan 298
Figure 48: Fruquintinib’s Clinical Development in NSCLC 300
Figure 49: Clinical and Commercial Positioning of Fruquintinib 304
Figure 50: Clinical Development of Avastin Biosimilars in NSCLC 306
Figure 51: Estimated Sales of Bevacizumab Biosimilars Versus Branded Avastin in NSCLC, 2015-2025 308
Figure 52: Abemaciclib’s Clinical Development in NSCLC 312
Figure 53: Clinical and Commercial Positioning of Abemaciclib 316
Figure 54: Tafinlar + Mekinist’s Clinical Development in NSCLC 320
Figure 55: Clinical and Commercial Positioning of Tafinlar + Mekinist 324
Figure 56: Veliparib’s Clinical Development in NSCLC 328
Figure 57: Clinical and Commercial Positioning of Veliparib 333
Figure 58: MM-121’s Clinical Development in NSCLC 336
Figure 59: Clinical and Commercial Positioning of MM-121 340
Figure 60: IMMU-132’s Clinical Development in NSCLC 343
Figure 61: Clinical and Commercial Positioning of IMMU-132 348
Figure 62: Plinabulin’s Clinical Development in NSCLC 351
Figure 63: Clinical and Commercial Positioning of Plinabulin 353
Figure 64: Sales for NSCLC in the US by Drug Class, 2015-2025 381
