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PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025

Published By :

GlobalData

Published Date : Nov 2016

Category :

Cancer

No. of Pages : 608 Pages

PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025

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.

For the purposes of this report, GlobalData considers the Global NSCLC market to include NSCLC-specific drug sales in the 8MM (US, 5EU [France, Germany Italy, Spain, and the UK], Japan, and China). The current market across these countries is dominated by the sale of major chemotherapy regimens, anti-angiogenic agents and targeted therapies for patients with EGFR+ and ALK+ NSCLC. GlobalData estimated that the Global NSCLC market was valued at $6.2b in 2015. The NSCLC therapeutics market is expected to grow at a positive CAGR of 15.7%, reaching 26.71b in the 8MM by 2025.

The growth of the NSCLC market during the forecast period will be driven partly by increasing incident cases of NSCLC in the US, 5EU, Japan, and China, as the population ages. In addition, the launch of premium-priced immuno-oncology (I/O) and targeted pipeline agents will drive the uptake of new therapies and prolong the duration of treatment in the first-line and beyond. The increased used of branded I/O therapies, such as Keytruda, Opdivo, and Tecentriq will be the primary driver of growth during the forecast period. The projected increase in mutation testing rate during the forecast period coupled with the launch of new generation EGFR and ALK TKIs, and BRAF inhibitors will significantly promote the sales of the targeted therapies, Tagrisso, Alecensa, and Tafinlar + Mekinist.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the NSCLC marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2015-2025)?
- What research and development (R&D) strategies will companies leverage to compete in the future NSCLC marketplace?
- Which pipeline products are poised to make a major clinical and commercial impact?
- What clinical and commercial factors are likely to influence NSCLC drug uptake in the 8MM?

Key Findings

- The increasing incorporation of premium-priced immune checkpoint inhibitor immunotherapies into the NSCLC treatment algorithm, particularly in the first-line setting, will be one major driver. Collectively, immunotherapies will reach $17.5B in sales by 2025, accounting for roughly 65% of total sales in the NSCLC market. Of the $17.5B total, Keytruda, Opdivo, and Tecentriq are projected to contribute $5.2B, $5.5B, and $2.8B, respectively.
- The increasing incidence of NSCLC in the 8MM will also drive growth. China, in particular, will see its NSCLC incident cases increase dramatically over the forecast period, at an Annual Growth Rate (AGR) of 4.7%. Overall, across the 8MM, the incidence of NSCLC is expected to increase at an AGR of 3.1% from 2015-2025. This increase, coupled with an anticipated increase in branded therapy prescriptions in China, will drive the growth of both the Chinese and global NSCLC markets over the forecast period.
- Patent expiration of several blockbuster drugs, including Tarceva and Alimta, and the uptake of generics will limit growth. GlobalData expects sales of the patented drug in the 8MM to decrease from $783M in 2015 to $18M by 2025. In addition, sales of Alimta will decrease from $2.1B in 2015 to $54M in 2025.
- An increasing emphasis on cost-consciousness is anticipated over the forecast period, which will limit premium pricing opportunities for developers of NSCLC pipeline agents. GlobalData expects this era of austerity and healthcare reform to make it increasingly more difficult for pharmaceutical companies to gain reimbursement approval for their new NSCLC therapies.

Scope

- Overview of NSCLC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline NSCLC drug market revenue from 2015-2025, annual cost of therapy (ACOT), and major product sales in 17 patient segments during the forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, R&D strategies, and clinical trial mapping for the NSCLC market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global NSCLC market. Insightful review of the key industry drivers, restraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global NSCLC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the NSCLC market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 26
2 Introduction 30
2.1 Catalyst 30
2.2 Related Reports 30
2.3 Upcoming Related Reports 31
3 Disease Overview 32
3.1 Etiology and Pathophysiology 32
3.2 Classification or Staging Systems 36
3.3 Symptoms 39
3.4 Prognosis 40
3.5 Quality of Life 42
4 Epidemiology 43
4.1 Disease Background 43
4.2 Risk Factors and Comorbidities 44
4.3 Global Trends 46
4.4 Forecast Methodology 49
4.5 Epidemiological Forecast for NSCLC (2015-2025) - Base Forecast 72
4.6 Epidemiological Forecast for NSCLC (2015-2025) - Alternate Forecast 86
4.7 Discussion 89
5 Disease Management 92
5.1 Diagnosis and Treatment Overview 92
5.2 US 102
5.3 France 103
5.4 Germany 104
5.5 Italy 105
5.6 Spain 106
5.7 UK 107
5.8 Japan 108
5.9 China 109
6 Competitive Assessment 110
6.1 Overview 110
6.2 Product Profiles - Major Brands, Epidermal Growth Factor Receptor-Targeting 112
6.3 Product Profiles - Major Brands, Anaplastic Lymphoma Kinase-Targeting 160
6.4 Product Profiles - Major Brands, Monoclonal Antibodies 181
6.5 Product Profiles - Major Brands, Other 216
6.6 Chemotherapies 231
7 Unmet Needs Assessment and Opportunity Analysis 233
7.1 Overview 233
7.2 First-Line Treatments That Extend Overall Survival in Advanced-Stage Nonsquamous NSCLC Without Actionable Mutations 235
7.3 Therapies Targeting Novel Biomarkers 238
7.4 Treatment Options for Squamous Patients in the First-Line and Third-Line Setting 242
7.5 Alternative Testing Options for Patients with Insufficient Biopsy Material 247
7.6 Treatments for Patients with Acquired Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Resistance 251
8 Pipeline Assessment 256
8.1 Overview 256
8.2 Promising Drugs in Clinical Development 258
8.3 Promising Drugs in Early-Stage Development 423
9 Current and Future Players 447
9.1 Overview 447
9.2 Trends in Corporate Strategy 452
9.3 Company Profiles 455
10 Market Outlook 478
10.1 Global Markets 478
10.2 US 485
10.3 5EU 492
10.4 Japan 499
10.5 China 505
11 Appendix 512
11.1 Bibliography 512
11.2 Abbreviations 558
11.3 Methodology 569
11.4 Forecasting Methodology 569
11.5 Primary Research - KOLs 596
11.6 About the Authors 600
11.7 About GlobalData 603
11.8 Disclaimer 603

1.1 List of Tables
Table 1: Definitions Used in the AJCC Lung Cancer Staging System 41
Table 2: AJCC Staging of NSCLC 42
Table 3: Symptoms of NSCLC 44
Table 4: Prognostic Factors for NSCLC 45
Table 5: Prognosis for NSCLC Based on Initial Staging 45
Table 6: Risk Factors and Comorbidities for Lung Cancer 49
Table 7: Histological Subtype Distribution Among NSCLC 52
Table 8: 8MM, Relative Survival 53
Table 9: 8MM, Sources Used for Diagnosed Incidence of NSCLC 54
Table 10: 8MM, Sources Used for Cancer Stage at Diagnosis 55
Table 11: 8MM, Sources Used for NSCLC by Histological Subtypes 57
Table 12: US, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 58
Table 13: 5EU, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 59
Table 14: Japan, Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 61
Table 15: China (Urban), Sources Used for Diagnosed Incident Cases of NSCLC Segmented by Mutation 62
Table 16: 8MM, Sources Used for Relative Survival of NSCLC 63
Table 17: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages 18 Years, N, Select Years 2015-2025 77
Table 18: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N (Row %), 2015 79
Table 19: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages 18 Years, N (Row %), 2015 81
Table 20: 8MM, Diagnosed Incident Cases of NSCLC by Clinical Stage at Diagnosis, Ages 18 Years, N, 2015 84
Table 21: 8MM, Diagnosed Incident Cases of NSCLC by Histological Subtypes, Ages 18 Years, N, 2015 85
Table 22: 8MM, Mutations Among Diagnosed Incident Cases of ADC, Both Sexes, Ages 18 Years, N, 2015 86
Table 23: 8MM, Mutations Among Diagnosed Incident Cases of SCC, Both Sexes, Ages 18 Years, N, 2015 87
Table 24: 8MM, Mutations Among Diagnosed Incident Cases of NSCLC, Both Sexes, N, Ages 18 Years, 2015 88
Table 25: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages 18 Years, N, Select Years 2015-2025 89
Table 26: 8MM, Alternate Forecast, Diagnosed Incident Cases of NSCLC by Histology Subtypes, Ages 18 Years, N, 2015 and 2025 91
Table 27: 8MM, Alternate Forecast, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages 18 Years, N, Select Years 2015-2025 93
Table 28: Prevalence of Brain and Bone Metastases in NSCLC 97
Table 29: Biomarker Testing Rates in Nonsquamous NSCLC 98
Table 30: Biomarker Testing Rates in Squamous NSCLC 99
Table 31: Treatment Guidelines for NSCLC 100
Table 32: Most Prescribed Drugs for NSCLC by Class in the 8MM, 2015-2025 100
Table 33: Country Profile - US 106
Table 34: Country Profile - France 107
Table 35: Country Profile - Germany 108
Table 36: Country Profile - Italy 109
Table 37: Country Profile - Spain 110
Table 38: Country Profile - UK 111
Table 39: Country Profile - Japan 112
Table 40: Country Profile - China 113
Table 41: Leading Treatments for NSCLC, 2016 115
Table 42: Marketed EGFR TKIs in NSCLC 118
Table 43: Product Profile - Tarceva 123
Table 44: Efficacy of Tarceva in First-Line Therapy, EGFR-mutant NSCLC 127
Table 45: Efficacy of Tarceva in Maintenance Therapy in NSCLC 128
Table 46: Efficacy of Tarceva in Second- and Third-Line Therapy in NSCLC 129
Table 47: Safety of Tarceva 130
Table 48: Tarceva SWOT Analysis, 2016 131
Table 49: Product Profile - Iressa 132
Table 50: Efficacy of Iressa in First-Line, EGFR-Mutant NSCLC (Study 1) 135
Table 51: Efficacy of Iressa in First-Line, EGFR-Mutant ADC NSCLC (Study 2) 135
Table 52: Safety of Iressa 136
Table 53: Iressa SWOT Analysis, 2016 137
Table 54: Product Profile - Gilotrif 139
Table 55: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 142
Table 56: Efficacy of Gilotrif in First-Line, EGFR-Mutant ADC 143
Table 57: Efficacy of Gilotrif in Second-Line, EGFR-Wildtype, EGFR TKI-Nave, Squamous NSCLC 143
Table 58: Efficacy of Gilotrif in Fourth-Line, EGFR-Mutant NSCLC 144
Table 59: Safety of Gilotrif 145
Table 60: Gilotrif SWOT Analysis, 2016 146
Table 61: Product Profile - Tagrisso 147
Table 62: Efficacy of Tagrisso in Second-Line, EGFR-Mutant NSCLC 150
Table 63: Safety of Tagrisso 151
Table 64: Tagrisso SWOT Analysis, 2016 152
Table 65: Product Profile - Portrazza 154
Table 66: Efficacy of Portrazza in First-Line, Squamous NSCLC 156
Table 67: Safety of Portrazza 157
Table 68: Portrazza SWOT Analysis, 2016 158
Table 69: Efficacy of Conmana in 2L Advanced NSCLC 161
Table 70: Efficacy of Conmana in 1L EGFR-mutant NSCLC 161
Table 71: Safety of Conmana 162
Table 72: Conmana SWOT Analysis, 2016 163
Table 73: Marketed ALK TKIs in NSCLC 164
Table 74: Product Profile - Xalkori 167
Table 75: Efficacy of Xalkori in Treatment-Nave ALK+ Metastatic NSCLC 169
Table 76: Efficacy of Xalkori in Previously Treated ALK+ Metastatic NSCLC 170
Table 77: Safety of Xalkori in Treatment-Nave, ALK+ Metastatic NSCLC 172
Table 78: Safety of Xalkori in Previously Treated, Metastatic NSCLC 173
Table 79: Xalkori SWOT Analysis, 2016 174
Table 80: Product Profile - Zykadia 175
Table 81: Efficacy of Zykadia 177
Table 82: Safety of Zykadia 178
Table 83: Zykadia SWOT Analysis, 2016 179
Table 84: Product Profile - Alecensa 180
Table 85: Efficacy of Alecensa 182
Table 86: Efficacy of Alecensa in NSCLC patients with CNS lesions 182
Table 87: Safety of Alecensa 184
Table 88: Alecensa SWOT Analysis, 2016 185
Table 89: Marketed PD-1/PD-L1 ICIs in NSCLC 186
Table 90: Product Profile - Opdivo 191
Table 91: Efficacy of Opdivo in Metastatic Squamous NSCLC 194
Table 92: Efficacy of Opdivo in Metastatic Nonsquamous NSCLC 195
Table 93: Safety of Opdivo 196
Table 94: Opdivo SWOT Analysis, 2016 197
Table 95: Product Profile - Keytruda 199
Table 96: Efficacy of Keytruda 202
Table 97: Safety of Keytruda 203
Table 98: Keytruda SWOT Analysis, 2016 204
Table 99: Product Profile - Tecentriq (atezolizumab) 206
Table 100: Patient Demographics in the Phase II POPLAR Trial (NCT01903993) 209
Table 101: Efficacy of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 211
Table 102: Efficacy of Tecentriq in the Phase III OAK Trial (NCT02008227) 212
Table 103: Patient Demographics in the Phase II FIR Trial (NCT01846416) 213
Table 104: Efficacy of Tecentriq in the Phase II FIR Trial (NCT01846416) 214
Table 105: Efficacy of Tecentriq in the Phase II BIRCH Trial (NCT02031458) 216
Table 106: Safety of Tecentriq in the Phase II POPLAR Trial (NCT01903993) 217
Table 107: Safety of Tecentriq in the Phase II FIR Trial (NCT01846416) 218
Table 108: Tecentriq SWOT Analysis, 2016 219
Table 109: Product Profile - Avastin 221
Table 110: Efficacy of Avastin in Nonsquamous NSCLC 224
Table 111: Safety of Avastin 225
Table 112: Avastin SWOT Analysis, 2016 225
Table 113: Product Profile - Cyramza 227
Table 114: Efficacy of Cyramza 229
Table 115: Safety of Cyramza 230
Table 116: Cyramza SWOT Analysis, 2016 231
Table 117: Product Profile - Vargatef 232
Table 118: Efficacy of Vargatef in ADC NSCLC 233
Table 119: Safety of Vargatef in ADC NSCLC 234
Table 120: Vargatef SWOT Analysis, 2016 235
Table 121: Summary of Chemotherapies, 2015 236
Table 122: Unmet Need and Opportunity in NSCLC 239
Table 123: Product Profile - Yervoy (ipilimumab) 267
Table 124: Demographics in the Phase II NCT00527735 Trial 269
Table 125: Efficacy of Yervoy + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 271
Table 126: Demographics in the Phase I CheckMate 012 Trial (NCT01454102) 272
Table 127: Efficacy of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 273
Table 128: Safety of Yervoy (ipilimumab) + Carboplatin + Paclitaxel in Advanced NSCLC (NCT00527735) 275
Table 129: Safety of the Opdivo + Yervoy Combination in the CheckMate 012 Trial (NCT01454102) 276
Table 130: Yervoy SWOT Analysis, 2016 278
Table 131: Product Profile - Avelumab (MSB-0010718C) 281
Table 132: Patient Demographics in the Phase Ib Dose-Expansion Study (NCT01772004) 283
Table 133: Efficacy of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 284
Table 134: Efficacy of Avelumab in PD-L1-Positive and -Negative NSCLC 285
Table 135: Demographics in the Treatment-Nave NSCLC Cohort in the Phase I Trial (NCT01772004) 286
Table 136: Efficacy of Avelumab in Treatment-Nave NSCLC 287
Table 137: Unconfirmed ORR According to PD-L1 Expression in Treatment-Nave NSCLC 288
Table 138: Safety of Avelumab in the Phase Ib Dose-Expansion Study (NCT01772004) 289
Table 139: Safety of Avelumab in Treatment-Nave NSCLC (NCT01772004) 290
Table 140: Avelumab SWOT Analysis, 2016 292
Table 141: Product Profile - Durvalumab (MEDI4736) 294
Table 142: Patient Demographics and Disease Characteristics in the Phase I/II NCT01693562 Trial 297
Table 143: Efficacy of Durvalumab in the Phase I/II NCT01693562 Trial 298
Table 144: Baseline Characteristics of Patients With Treatment-Nave NSCLC in the Phase I/II 299
Table 145: Efficacy of Durvalumab in Treatment-Nave NSCLC 300
Table 146: Patient Demographics and Disease Characteristics in the Phase Ib NCT02000947 Trial 301
Table 147: Efficacy of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 303
Table 148: Safety of Durvalumab in the Phase I/II Trial (NCT01693562) 304
Table 149: Safety of Durvalumab in Treatment-Nave NSCLC 305
Table 150: Safety of Durvalumab + Tremelimumab in the Phase Ib NCT02000947 Trial 306
Table 151: Durvalumab SWOT Analysis, 2016 308
Table 152: Product Profile - Naquotinib Mesylate (ASP8273) 312
Table 153: Patient Demographics in the Phase I/II NCT02192697 and Phase I NCT02113813 Trials 313
Table 154: Efficacy of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 314
Table 155: Safety of Naquotinib in EGFR-Mutant NSCLC in Japanese and US Patients 315
Table 156: Naquotinib SWOT Analysis, 2016 316
Table 157: Product Profile - Olmutinib (BI 1482694; HM61713) 317
Table 158: Demographics in the Phase I/II NCT01588145 Trial 319
Table 159: Efficacy of Olmutinib in the Phase II Portion of the NCT01588145 Trial 320
Table 160: Safety Profile of Olmutinib in the Phase II Portion of the NCT01588145 Trial 321
Table 161: Olmutinib SWOT Analysis, 2016 322
Table 162: Product Profile - Dacomitinib 324
Table 163: Demographics in the Phase II NCT00818441 Trial 326
Table 164: Efficacy of Dacomitinib in the Phase II NCT00818441 Trial 327
Table 165: Safety of Dacomitinib in Phase II NCT00818441 Trial 329
Table 166: Dacomitinib SWOT Analysis, 2016 330
Table 167: Product Profile - Ensartinib 333
Table 168: Baseline Patient Characteristics in the Phase I/II eXalt2 Trial (NCT0162534) 334
Table 169: Efficacy of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 335
Table 170: Baseline Patient Characteristics in the Expansion Cohort of the Phase I/II eXalt2 Trial 336
Table 171: Efficacy of Ensartinib in the Expansion Phase of the eXalt2 Trial (NCT0162534) 337
Table 172: Safety of Ensartinib in the Phase I/II eXalt2 Trial (NCT0162534) 338
Table 173: Ensartinib SWOT Analysis, 2016 339
Table 174: Product Profile - Brigatinib 341
Table 175: Baseline Patient Characteristics in the Phase II ALTA Trial (NCT02094573) 343
Table 176: Efficacy of Brigatinib in the Phase II ALTA Trial (NCT02094573) 344
Table 177: Efficacy of Brigatinib in ALK+ NSCLC with Intracranial CNS Metastases 345
Table 178: Safety of Brigatinib in the Phase II ALTA Trial (NCT02094573) 346
Table 179: Brigatinib SWOT Analysis, 2016 347
Table 180: Product Profile - CimaVax-EGF 350
Table 181: Demographics in the Phase III trial of the CimaVax-EGF in Cuba 352
Table 182: Efficacy of the CimaVax-EGF in the Phase III trial in Cuba 353
Table 183: Safety of the CimaVax-EGF in the Phase III Trial in Cuba 354
Table 184: CimaVax-EGF SWOT Analysis, 2016 356
Table 185: Product Profile - Tedopi 358
Table 186: Demographics in the Phase II Trial of Tedopi in Advanced NSCLC 359
Table 187: Efficacy of Tedopi in Advanced NSCLC 360
Table 188: Tedopi SWOT Analysis, 2016 362
Table 189: Product Profile - Anlotinib 364
Table 190: Efficacy of Anlotinib in Pretreated NSCLC in the Phase II ALTER0302 Trial 365
Table 191: Anlotinib SWOT Analysis, 2016 366
Table 192: Product Profile - Aitan 368
Table 193: Efficacy of Aitan in Pretreated Nonsquamous NSCLC 369
Table 194: Aitan SWOT Analysis, 2016 370
Table 195: Product Profile - Fruquintinib 372
Table 196: Baseline Demographics in the Phase I Trial (HMP, NCT01645215) of Fruquintinib 373
Table 197: Efficacy of Fruquintinib in Advanced Solid Tumors 374
Table 198: Safety of Fruquintinib in Advanced Solid Tumors 375
Table 199: Fruquintinib SWOT Analysis, 2016 376
Table 200: Efficacy and Safety of ABP 215 in NSCLC in the Phase III Trial (NCT01966003) 379
Table 201: Product Profile - Abemaciclib 383
Table 202: Efficacy of Abemaciclib Monotherapy in Previously Treated NSCLC (NCT01394016) 385
Table 203: Efficacy of Abemaciclib in Combination with Other Therapies (NCT02079636) 386
Table 204: Safety of Abemaciclib in Combination with Multiple Single Agents 387
Table 205: Abemaciclib SWOT Analysis, 2016 389
Table 206: Product Profile - Tafinlar + Mekinist 391
Table 207: Demographics in Cohort B of the Pivotal Phase II BRF113928 Trial (GSK, NCT01336634) 393
Table 208: Efficacy of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 394
Table 209: Safety of Tafinlar + Mekinist in Previously Treated BRAF V600E+ NSCLC 395

1.2 List of Figures
Figure 1: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages 18 Years, N, Select Years 2015-2025 77
Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of NSCLC, Both Sexes, N, 2015 80
Figure 3: 8MM, Sex-Specific Diagnosed Incident Cases of NSCLC, Ages 18 Years, N, 2015 82
Figure 4: 8MM, Age-Standardized Diagnosed Incidence of NSCLC, Ages 18 Years, N, 2015 83
Figure 5: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Both Sexes, Ages 18 Years, N, Select Years 2015-2025 90
Figure 6: Disease Management Flowchart for nonsquamous NSCLC 102
Figure 7: Disease Management Flowchart for squamous NSCLC 103
Figure 8: Disease Management Flowchart for EGFR+ NSCLC 104
Figure 9: Disease Management Flowchart for ALK+ NSCLC 105
Figure 10: Tarcevas Phase III Development in NSCLC 124
Figure 11: Iressas Phase II Development in NSCLC 133
Figure 12: Gilotrifs Phase III Development in NSCLC 141
Figure 13: Tagrissos Phase III Development in NSCLC 148
Figure 14: Portrazzas Phase II Development in NSCLC 155
Figure 15: Conmanas Phase III Development in NSCLC 160
Figure 16: Xalkoris Development in NSCLC 168
Figure 17: Zykadias Development in NSCLC 176
Figure 18: Alecensas Development in NSCLC 181
Figure 19: Opdivos Development in NSCLC 193
Figure 20: Keytrudas Phase III Development in NSCLC 201
Figure 21: Tecentriqs Clincal Development in NSCLC 208
Figure 22: Avastins Phase III Development in NSCLC 222
Figure 23: Cyramzas Phase III Development in NSCLC 228
Figure 24: Vargatefs Phase II Development in NSCLC 233
Figure 25: NSCLC - Phase II/III Pipeline, 2016, Part I 262
Figure 26: NSCLC - Phase II/III Pipeline, 2016, Part II 263
Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 2015-2025 264
Figure 28: Yervoys Clinical Development in NSCLC 268
Figure 29: Clinical and Commercial Positioning of Yervoy 277
Figure 30: Estimated Sales of Ipilimumab Biosimilars Versus Branded Yervoy in NSCLC, 2015-2025 279
Figure 31: Avelumabs Development in NSCLC 282
Figure 32: Clinical and Commercial Positioning of Avelumab 291
Figure 33: Durvalumabs Clinical Development in NSCLC 295
Figure 34: Clinical and Commercial Positioning of Durvalumab 307
Figure 35: Naquotinibs Clincal Development in NSCLC 312
Figure 36: Clinical and Commercial Positioning of Naquotinib 315
Figure 37: Olmutinibs Clincal Development in NSCLC 318
Figure 38: Clinical and Commercial Positioning of Olmutinib 321
Figure 39: Dacomitinibs Clinical Development in NSCLC 324
Figure 40: Clinical and Commercial Positioning of Dacomitinib 330
Figure 41: Ensartinibs Clinical Development in NSCLC 333
Figure 42: Clinical and Commercial Positioning of Ensartinib 338
Figure 43: Brigatinibs Clinical Development in NSCLC 342
Figure 44: Clinical and Commercial Positioning of Brigatinib 347
Figure 45: CimaVax-EGFs Clinical Development in NSCLC 351
Figure 46: Clinical and Commercial Positioning of CimaVax-EGF 355
Figure 47: Tedopis Clinical Development in NSCLC 358
Figure 48: Clinical and Commercial Positioning of Tedopi 361
Figure 49: Anlotinibs Clinical Development in NSCLC 364
Figure 50: Clinical and Commercial Positioning of Anlotinib 366
Figure 51: Aitans Clinical Development in NSCLC 368
Figure 52: Clinical and Commercial Positioning of Aitan 370
Figure 53: Fruquintinibs Clinical Development in NSCLC 372
Figure 54: Clinical and Commercial Positioning of Fruquintinib 376
Figure 55: Clinical Development of Avastin Biosimilars in NSCLC 378
Figure 56: Estimated Sales of Bevacizumab Biosimilars Versus Branded Avastin in NSCLC, 2015-2025 380
Figure 57: Abemaciclibs Clinical Development in NSCLC 384
Figure 58: Clinical and Commercial Positioning of Abemaciclib 388
Figure 59: Tafinlar + Mekinists Clinical Development in NSCLC 392
Figure 60: Clinical and Commercial Positioning of Tafinlar + Mekinist 396
Figure 61: Veliparibs Clinical Development in NSCLC 400
Figure 62: Clinical and Commercial Positioning of Veliparib 405
Figure 63: MM-121s Clinical Development in NSCLC 408
Figure 64: Clinical and Commercial Positioning of MM-121 412
Figure 65: IMMU-132s Clinical Development in NSCLC 415
Figure 66: Clinical and Commercial Positioning of IMMU-132 420
Figure 67: Plinabulins Clinical Development in NSCLC 423
Figure 68: Clinical and Commercial Positioning of Plinabulin 425
Figure 69: Global Sales of Branded Products for NSCLC by Company, 2015-2025 455
Figure 70: Company Portfolio Gap Analysis in NSCLC, 2015-2025 456
Figure 71: Roche/Genentech SWOT Analysis in NSCLC, 2016 462
Figure 72: Eli Lilly SWOT Analysis in NSCLC, 2016 465
Figure 73: Pfizer SWOT Analysis in NSCLC, 2016 468
Figure 74: AZ SWOT Analysis in NSCLC, 2016 471
Figure 75: BMS SWOT Analysis in NSCLC, 2016 474
Figure 76: Merck & Co. SWOT Analysis in NSCLC, 2016 477
Figure 77: Novartis SWOT Analysis in NSCLC, 2016 479
Figure 78: BI SWOT Analysis in NSCLC, 2016 481
Figure 79: Global Sales for NSCLC (8MM), 2015-2025 483
Figure 80: Global Sales for NSCLC (8MM), 2015-2025 484
Figure 81: Global Sales for NSCLC (8MM), 2015-2025 485
Figure 82: Sales for NSCLC in the US by Drug Class, 2015-2025 491
Figure 83: Sales for NSCLC in the 5EU by Drug Class, 2015-2025 498
Figure 84: Sales for NSCLC in Japan, 2015-2025 504
Figure 85: Sales for NSCLC in urban China by Drug Class, 2015-2025 510

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