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Immune Checkpoint Inhibitors (PD-1 & PD-L1 Targeting Drugs): Analysis of Clinical Trial Results (Featuring Insightful Summaries of Recently Published Trial Results, Contemporary Pipeline Review, Clinical Trial Analysis, Clinical Publications Analysis, and Estimated Time to Market Analysis for Novel Drug Candidates)

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    February 2022

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Immune-Checkpoint-Inhibitors-Patient-Selection Immune-Checkpoint-Inhibitors-Clinical-Study-Design Immune-Checkpoint-Inhibitors-Important-Criterion Immune-Checkpoint-Inhibitors-New-Therapeutic-Agent Immune-Checkpoint-Inhibitors-Different-Groups-of-Patients Immune-Checkpoint-Inhibitors-Summary-of-Outcome-Measures Immune-Checkpoint-Inhibitors-Therapeutic-Efficacy Immune-Checkpoint-Inhibitors-Evaluation-Criteria
Immune-Checkpoint-Inhibitors-Regulatory-Review Immune-Checkpoint-Inhibitors-Better-Alternatives Immune-Checkpoint-Inhibitors-Different-Types-of-Adverse-Events Immune-Checkpoint-Inhibitors-Treatment-related-Adverse-Events Immune-Checkpoint-Inhibitors-Detailed-Summaries Immune-Checkpoint-Inhibitors-Estimated Time-To-Launch-Analysis    

Overview

Cancer is one of the leading causes of death, worldwide. In 2020 alone, over 19 million new cases of the disease (affecting different organs) and close 10 million associated fatalities, were reported worldwide. Over the next couple of decades, experts believe that the global cancer burden is likely to increase by almost 50%. Currently, a variety of therapeutic measures are available for the treatment of different types of cancers; of these, surgery, chemotherapy, and radiation therapy, are considered the current standards of care. However, the efficacy of the aforementioned procedures has been shown to be severely limited, especially in treating advanced-stage cancers that have metastasized beyond their respective points of origin. Additionally, the non-specific and highly toxic nature of both chemotherapy and radiation therapy is known to significantly deteriorate quality of life. Over the last couple of decades, several targeted, anti-cancer therapies have been developed, and many are already available in the market. Of these, immune checkpoint directed therapies, which are designed to prevent malignantly transformed cells from evading immune surveillance, have demonstrated a lot of potential in treating a variety of cancer types.

The programmed cell death protein 1 receptor (PD-1) receptor, and programmed death ligand 1 (PD-L1) are known to negatively regulate T-cell-mediated immune responses. Multiple studies have shown that the activation of PD-1 / PD-L1 signaling is a mechanism used by tumors to evade a T-cell based immunological response. This led to the development of the hypothesis that PD-1 / PD-L1 blockade may prove to be an effective form of anti-cancer therapy that is capable of harnessing the key mediators of the adaptive human immune system. KEYTRUDA® (pembrolizumab), the first PD-1 targeting anti-cancer therapy was approved by the FDA in September 2014 for the treatment of patients suffering from advanced / unresectable melanoma who were no longer responding to other forms of treatment. Later, in the same year, OPDIVO® (nivolumab), another PD-1 targeting therapy, was approved by the FDA. These immune checkpoint inhibitors soon demonstrated the fact that they were both viable and potent therapeutic options and had the ability to substantially prolong the lives of patients suffering from advanced stage tumors. As a result, till date, there are seven approved drugs against PD-1 and PD-L1, and several more under development. Drug developers are now capitalizing on the success of PD-1 blockade in several different types of malignancies, and also researching alternative areas of application. Consequently, this field of research is abuzz with activity both at the clinical and preclinical levels. This report provides a deeper perspective on some of the recently published results from completed and ongoing clinical research activity.

Scope of the Report

The “Immune Checkpoint Inhibitors (PD-1 & PD-L1 Targeting Drugs): Analysis of Clinical Trial Results” report provides detailed information on the contemporary R&D efforts related to an important segment of the immune checkpoint inhibitors market, specifically the drugs / drug candidates that have been developed to target the PD-1 and PD-L1 molecules. It offers a technical perspective of the innovation in this domain, in terms of products in the pipeline, clinical research activity, and trend of scientific publications (focused on clinical trial results). The information in this report has been presented across two deliverables, featuring an interactive MS Excel sheet and a MS PowerPoint pack, which summarizes the key takeaways from the project, and insights drawn from the curated data. The report features the following details:

  • Detailed summaries of published clinical research results, featuring key insights related to completed and ongoing trials of PD-1 and PD-L1 inhibitors. For each trial, we have provided an elaborate [A] overview (including details of the related publication, and names of the journal and authors, trial ID, mentioned phase of development, sponsor(s), target indications, important study-related dates and locations of hospitals / centers involved), and also collated and presented information on the [B] clinical study design (featuring study type, primary purpose, total enrollment, allocation, intervention model, type of masking used, among others, along with information on the participant screening process, treatment plan and follow-up plan), [C] key research outcomes (based on information available in the dedicated trial related webpage), [D] reported results (segregated across both primary and secondary endpoints, featuring important participant and key parameter assessment related details, and key insights mentioned in the affiliated publication(s)) and [E] treatment related adverse events (including both treatment- and immune related events, segregated across different grades of severity)
  • A review of the current market landscape of PD-1 & PD-L1 targeting immune checkpoint therapies, providing information on phase of development, type of molecule, biological target, and mechanism of action. In addition, the section includes details on the key developers of PD-1 / PD-L1 based drugs, along with information on their respective year of establishment, company size, and location of headquarters. 
  • A clinical trial analysis, offering information on trial registration year, phase of development, enrolled patient population, study design, key sponsors (and their respective collaborators), popular target therapeutic area, and geography. The insights from this analysis are organized to provide an informed perspective on the historical and recent pace of innovation in this domain.
  • An insightful publication analysis, taking into account only clinical trial results that have been published in peer-reviewed, scientific journals. The analysis highlights key trends observed across the aforementioned articles, including those related to year of publication, biological target, target therapeutic areas(s), key journals (in terms of number of articles published in this domain and impact factor of the journal), and popular authors (taking into consideration only the first authors of the mentioned publications). The insights from this analysis are organized to provide an informed perspective on the historical and recent trends of publishing activity, in this field of research. 
  • An informed perspective concerning the likely time of launch for all the PD-1 / PD-L1 targeting drugs candidates that have not yet been approved. This analysis takes into consideration the current phase of development, time required for regulatory submissions and review, and other parameters that are expected to drive the transition from the clinic to the market.

DELIVERABLE OUTLINES

Excel Deliverables
Section I is a dashboard, featuring a pictorial summary of the key inclusions of the report.

Section II is a tabular representation of the contemporary PD-1 / PD-L1 inhibitors pipeline, including details on their respective developers.

Section III features data from clinicaltrials.gov which was used for a historical clinical trial analysis of studies featuring PD-1 and PD-L1 inhibitors.

Section IV includes a list of clinical trial result-related publications, sourced from PubMed, which was further analyzed to identify articles focused on singular clinical trials. The latter types of publications were shortlisted, linked to the corresponding clinical study-related information, and used for the trials results analysis.

Section V is a tabular representation of the clinical trials for which detailed publications of results are available in PubMed. 

Section VI features the input data used for the estimated time to launch analysis.

Section VII includes a set of appendices, featuring pivot tables and other inputs that drive the interactive elements in the summary dashboard. 

PowerPoint Deliverable: Key Section Outlines
Section I is an executive summary of all the key takeaways from the report. 

Section II features a detailed analysis of all clinical trial (phase I, phase II and phase III) results, which have been published in reputed, scientific journals in the period between 2020 and 2021, related to PD-1 / PD-L1 targeting drugs. The insights generated were categorized into the following sections: general trial related details, pictorial representation of study design and treatment plan, participant-related information, primary and secondary study related outcomes, tools used for patient selection and statistical analysis of clinical data, key inputs from study endpoints, and observed adverse events.

Section III features a detailed review of the current market landscape of PD-1 & PD-L1 targeting immune checkpoint therapies, offering insights on phase of development, type of molecule, biological target, and mechanism of action. In addition, the section includes details on the key developers of PD-1 / PD-L1 based drugs, along with information on their respective year of establishment, company size, and location of headquarters. 

Section IV presents the clinical trial analysis, offering inputs related to key trends associated with trial registration year, phase of development, enrolled patient population, study design, key sponsors (and their respective collaborators), popular target therapeutic area, and geography. The insights from this analysis are organized to provide an informed perspective on the historical and recent pace of innovation and clinical research activity in this domain.

Section V provides insight from a detailed publication analysis, taking into account only clinical trial results that have been published in peer-reviewed, scientific journals. It also features our independent opinion related to trends observed across the aforementioned articles, including those related to year of publication, biological target, target therapeutic areas(s), key journals (in terms of number of articles published in this domain and impact factor of the journal), and popular authors (taking into consideration only the first authors of the mentioned publications).

Section VI offers an informed perspective concerning the likely time of launch for all the PD-1 / PD-L1 targeting drugs candidates that have not yet been approved. This analysis takes into consideration the current phase of development, time required for regulatory submissions and review, and other parameters that are expected to drive the transition from the clinic to the market.

Section VII provides a proprietary perspective on the future of immune checkpoint inhibitors, primarily focusing on drugs that target the PD-1 receptor and its ligand, PD-L1. This part of the report highlights what can be expected in terms of likely product launches, future application areas, potential for being used in combination with other drugs / therapies and estimated size of the PD-1 / PD-L1 therapies market.

Section VIII is an appendix, featuring a list of tables (representing numerical data from the charts and graphs in the deliverable) and a list of companies and organizations captured during the course of the study.

Contents

Table Of Contents

Excel Deliverable
1.Summary Dashboard

1.1. Pipeline Review
1.2. Clinical Trials Analysis
1.3. Analysis of Clinical Trial Results-related Publications
1.4. Analysis of Clinical Trial Results-related Publications, 2020-2021
1.5. Estimated Time to Launch Analysis

2. Contemporary Product Pipeline Dataset

3. Clinical Trials Dataset

4. Clinical Trial Results-related Publications Dataset

5. Clinical Trial Results Analysis Dataset

6. Estimated Time to Launch Dataset

7. Appendices

PowerPoint Deliverable
1. Context

2. Project Approach

3. Project Objectives

Section I

4. Executive Summary

Section II
5. Analysis of Clinical Trial Results

5.1. Overview
5.2. Scope and Methodology
5.3. PD-1 & PD-L1 Inhibitors: Phase I Trials
5.4. PD-1 & PD-L1 Inhibitors: Phase II Trials
5.5. PD-1 & PD-L1 Inhibitors: Phase III Trials
5.6. Concluding Remarks

Section III
6. Contemporary Product Pipeline Dataset

6.1. Overview
6.2. PD-1 & PD-L1 Inhibitors Pipeline
6.2.1. Analysis by Biological Target
6.2.2. Analysis by Type of Molecule
6.2.3. Analysis by Phase of Development
6.2.4. Analysis by Mechanism of Action
6.3. PD-1 & PD-L1 Inhibitors: Developer Landscape
6.3.1. Analysis by Year of Establishment
6.3.2. Analysis by Company Size
6.3.3. Analysis by Location of Headquarters
6.4. Concluding Remarks

Section IV
7. Clinical Trials Analysis

7.1. Overview
7.2. PD-1 & PD-L1 Inhibitors: Clinical Trials
7.2.1. Analysis by Trial Registration Year
7.2.2. Analysis by Trial Phase
7.2.3. Analysis by Enrolled Patient Population
7.3.4. Analysis by Study Design
7.3.5. Analysis by Sponsor / Collaborator
7.3.6. Most Active Industry Players: Analysis by Number of Registered Trials
7.3.7. Most Active Non-Industry Players: Analysis by Number of Registered Trials
7.3.8. Analysis by Target Therapeutic Area
7.3.9. Geographical Analysis by Number of Registered Trials
7.3.10. Geographical Analysis by Enrolled Patient Population

Section V
8. Clinical Trial Results-related Publications Dataset

8.1. Overview
8.2. Scope and Methodology
8.3. PD-1 & PD-L1 Inhibitors: List of Clinical Trial-related Publications
8.3.1. Analysis by Year of Publication
8.3.2. Analysis by Biological Target
8.3.3. Analysis by Target Therapeutic Area
8.3.4. Key Journals: Analysis by Number of Publications
8.3.5. Key Journals: Analysis by Impact Factor
8.3.6. Most Popular First Authors: Analysis by Number of Publications
8.4. Concluding Remarks

Section VI
9. Estimated Time to Launch

9.1. Overview
9.2. Scope and Methodology
9.3. PD-1 & PD-L1 Inhibitors: Estimated Time to Launch for Novel Drug Candidates
9.4. Concluding Remarks

Section VII
10. Conclusion

Section VIII
11. Appendices I: Tabulated Data

12. Appendices II: List of Companies & Organizations

List Of Companies

The following companies / institutes / government bodies and organizations have been mentioned in this report.

  1. 4-Antibody AG
  2. Abbott
  3. AbbVie
  4. AbClon
  5. Abeome
  6. ABL Bio
  7. Abpro
  8. Acerta Pharma
  9. Acrus Biosciences
  10. Actinium Pharmaceuticals
  11. Adaptive Biotechnologies
  12. Adimab
  13. AdoRx Therapeutics
  14. Aduro Biotech
  15. Advaxis
  16. Agenus
  17. Agios Pharmaceuticals
  18. AgonOX
  19. Alexion Pharmaceuticals
  20. Allergan
  21. Alligator Bioscience 
  22. Alpine Immune Sciences
  23. ALX Oncology
  24. Ambrx
  25. American Society of Clinical Oncology
  26. Amgen
  27. Amplimmune
  28. AnaptysBio
  29. Angel Therapeutics
  30. Anvil Biosciences (The company has been acquired)
  31. Apexigen
  32. Apogenix
  33. Aptevo Therapeutics
  34. Arch Oncology
  35. Arcus Biosciences
  36. arGEN-X
  37. ArQule
  38. Astellas Pharma
  39. Astex Pharmaceuticals
  40. AstraZeneca
  41. Atridia
  42. Aurigene
  43. Aurigene Discovery Technologies
  44. Avacta Life Sciences
  45. Azienda Ospedaliera Universitaria Senese
  46. Bach BioSciences
  47. Bayer
  48. BeiGene
  49. BinDeBio Group
  50. BIOCAD
  51. Biodextris
  52. Bio-Matrix Scientific Group
  53. BioNTech
  54. Bio-Techne
  55. BioWa
  56. Black Belt Therapeutics
  57. BliNK Biomedical
  58. bluebird bio
  59. Boehringer Ingelheim
  60. Boston Medical Center 
  61. Brigham and Women's Hospital
  62. Bristol Myers Squibb
  63. Bristol-Myers Squibb
  64. Calithera Biosciences
  65. CALIXAR
  66. Canadian Cancer Trials Group
  67. CASI Pharmaceuticals
  68. Catalent Biologics
  69. Celgene
  70. Cell Genesys 
  71. Celldex Therapeutics
  72. Center for Applied Medical Research 
  73. Centre Georges Francois Leclerc
  74. Centro Nacional de Investigaciones Oncologicas CARLOS III
  75. Centrose
  76. Changhai Hospital
  77. Checkpoint Therapeutics
  78. China National Biotec Group
  79. City of Hope Medical Center
  80. CleveXel Pharma
  81. Clinical Research Institute 
  82. Columbia University
  83. Columbia University Irving Medical Center
  84. Compass Therapeutics
  85. Compugen
  86. Corvus Pharmaceuticals
  87. CoStim Pharmaceuticals
  88. Crescendo Biologics
  89. CStone Pharmaceuticals
  90. CureTech
  91. Curis
  92. D5Pharma
  93. Daiichi Sankyo
  94. Dana-Farber Cancer Institute
  95. Distributed Bio
  96. DNAtrix
  97. Domain Therapeutics
  98. Dova Pharmaceuticals
  99. Dualogics
  100. Eddingpharm
  101. Eisai
  102. Eli Lilly
  103. Elpiscience Biopharma
  104. ELSALYS BIOTECH
  105. EMulate Therapeutics
  106. EpicentRx
  107. European Thoracic Oncology Platform
  108. Facet Biotech
  109. FF Pharmaceuticals
  110. Five Prime Therapeutics
  111. Fondazione IRCCS Istituto Nazionale dei Tumori
  112. Forty Seven
  113. Fred Hutchinson Cancer Research Center
  114. F-star
  115. Gateway Biologics
  116. Genentech
  117. Genmab
  118. Genomics Medicine Ireland
  119. Genosco
  120. Georgia Health Sciences University
  121. GERCOR - Multidisciplinary Oncology Cooperative Group
  122. GigaGen
  123. Gilead Sciences
  124. Glaxosmithkline
  125. Glenmark
  126. Glycotope 
  127. Grupo Espanol de Investigacion en Sarcomas
  128. Gustave Roussy Institute 
  129. Hanmi Pharmaceutical
  130. HanX Biopharmaceuticals 
  131. HealthCare Ventures
  132. Heat Biologics
  133. Hoffmann-La Roche
  134. Hospices Civils de Lyon
  135. Hrain Biotechnology
  136. Hummingbird Bioscience
  137. IDM
  138. IGM Biosciences
  139. I-Mab Biopharma
  140. Immatics
  141. ImmuneOncia Therapeutics
  142. ImmuneOnco Biopharmaceuticals
  143. ImmuNext
  144. Immutep
  145. Imperial College London
  146. Impetis Biosciences 
  147. Incyte
  148. Inhibrx
  149. Innate Pharma
  150. Innovent Biologics
  151. Institute for Research in Biomedicine
  152. InteRNA Technologies
  153. International Myeloma Foundation
  154. IO Biotech
  155. iOnctura
  156. iTeos Therapeutics
  157. Janssen Pharmaceuticals
  158. Jiangsu HengRui Medicine
  159. Jiangxi Qingfeng Pharmaceutical
  160. JN Biosciences
  161. Johns Hopkins University
  162. Johnson & Johnson
  163. Jounce Therapeutics
  164. Juventas Cell Therapy
  165. KAHR Medical
  166. Kiniksa Pharmaceuticals
  167. Kite Pharma
  168. Kleo Pharmaceuticals
  169. Kymab
  170. Kyowa Hakko Kirin
  171. Lankenau Institute for Medical Research (LIMR)
  172. Laureate Pharma
  173. Leap Therapeutics
  174. Lee's Pharma 
  175. LG Chem
  176. LifeArc
  177. Lonza Biologics
  178. Ludwig Cancer Research
  179. Lynkcell 
  180. M.D. Anderson Cancer Center
  181. Macrocure
  182. MacroGenics 
  183. Marino Biotechnology
  184. Masonic Cancer Center
  185. Massachusetts General Hospital
  186. Medarex
  187. MedImmune
  188. Medivation
  189. Merck 
  190. Merck KGaA
  191. Merck Serono
  192. Merck Sharp & Dohme
  193. Merus
  194. Millennium Pharmaceuticals
  195. Moderna
  196. Molecular Partners
  197. MolMed
  198. Momenta Pharmaceuticals
  199. Morphiex
  200. MorphoSys
  201. Mount Sinai Innovation Partners
  202. MRC Technology
  203. Nanjing Chia Tai Tianqing
  204. National Cancer Center Hospital East
  205. National Cancer Institute
  206. National Heart, Lung, and Blood Institute
  207. National Institute of Allergy and Infectious Diseases
  208. National Institute of Biomedical Imaging and Bioengineering
  209. National Institute of Dental and Craniofacial Research
  210. National Institute of Diabetes and Digestive and Kidney Diseases
  211. National Institute of Neurological Disorders
  212. NavarraBiomed-Biomedical Research Centre
  213. Navigen
  214. Nektar Therapeutics
  215. Neon Therapeutics
  216. NewLink Genetics
  217. NextCure
  218. Northwestern University
  219. Novartis
  220. Novartis Pharmaceuticals
  221. Novimmune
  222. Novo Nordisk
  223. Numab Therapeutics
  224. Ogeda
  225. OncoArendi Therapeutics 
  226. Oncotelic
  227. Oncothyreon
  228. Ono Pharmaceutical
  229. Onyx (subsidiary of Amgen) 
  230. Orega Biotech
  231. ORIC Pharmaceuticals
  232. OSE Immunotherapeutics
  233. Oslo University Hospital
  234. Palobiofarma
  235. Pandion Therapeutics
  236. Paradigm Shift Therapeutics
  237. Parker Institute for Cancer Immunotherapy
  238. Pascal Biosciences
  239. PDL Biopharma
  240. Peking University
  241. Peking University People's Hospital
  242. Peloton Therapeutics
  243. PeptiDream
  244. PersonGen BioTherapeutics (Suzhou) 
  245. Pfizer
  246. PharmAbcine
  247. Pieris Pharmaceuticals
  248. Pierre Fabre
  249. Pinze Lifetechnology
  250. Polaris Group
  251. Potenza Therapeutics
  252. Prima BioMed 
  253. PsiOxus Therapeutics
  254. Recipharm Cobra Biologics
  255. Regeneron Pharmaceuticals
  256. Regis Technologies 
  257. Roche
  258. Royal Marsden NHS Foundation Trust
  259. Rubius Therapeutics
  260. Samsung Biologics
  261. Samsung Medical Center
  262. Sanofi
  263. Sanquin
  264. Seattle Genetics
  265. Servier
  266. Shanghai GeneChem
  267. Shanghai Junshi Bioscience
  268. Shattuck Labs
  269. Shire
  270. Sorrento Therapeutics
  271. Spring Bioscience
  272. Stanford University
  273. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  274. Surface Oncology
  275. Sutro Biopharma
  276. Swedish Orphan Biovitrum
  277. Symphogen
  278. Synthon International Holding
  279. Syros Pharmaceuticals
  280. Taizhou Hanzhong biomedical
  281. Takeda Pharmaceutical
  282. Tarus Therapeutics 
  283. Tempest Therapeutics
  284. TESARO
  285. TG Therapeutics
  286. The First Affiliated Hospital with Nanjing Medical University
  287. The National Cancer Institute, Mexico
  288. The Netherlands Cancer Institute
  289. The University of Texas MD Anderson Cancer Center
  290. Tianjin Medical University Cancer Institute and Hospital
  291. ToleroTech
  292. Tottori University
  293. TRACON Pharmaceuticals
  294. Trellis Biosciences
  295. TRIGR Therapeutics
  296. Trillium Therapeutics
  297. Tsinghua University
  298. Union Stem Cell & Gene Engineering
  299. University Health Network, Toronto
  300. University Medical Center Hamburg-Eppendorf
  301. University of Birmingham
  302. University of California, Berkeley
  303. University of California, Los Angeles
  304. University of California, San Diego
  305. University of California, San Francisco
  306. University of Cologne
  307. University of Iowa Pharmaceutical Services
  308. University of Louisville
  309. University of Minnesota 
  310. University of Texas 
  311. Vall d’Hebron Institute of Oncology
  312. Valo Therapeutics
  313. Ventana Medical Systems
  314. Viela Bio
  315. ViraTherapeutics 
  316. Vivoryon Therapeutics
  317. Washington University
  318. Waterstone Hanxbio 
  319. Weill Medical College of Cornell University
  320. Xencor
  321. XOMA
  322. Yale Cancer Center
  323. Yale University
  324. Y-Biologics
  325. Y-mAbs Therapeutics
  326. Yuhan Pharmaceuticals
  327. Zai Lab
  328. Zymeworks

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