《诺为泰（Novotech）：非小细胞肺癌：全球临床试验概况报告（2024)（英文版）（21页）.pdf》由会员分享，可在线阅读，更多相关《诺为泰（Novotech）：非小细胞肺癌：全球临床试验概况报告（2024)（英文版）（21页）.pdf（21页珍藏版）》请在三个皮匠报告上搜索。

1、novotech-MAY 8,2024Non-Small Cell Lung Cancer-Global Clinical Trial Landscape(2024)The Asia-Pacific region shows shorter recruitment durations and faster recruitment rates compared to the USNSCLC originates from larger cells lining the airways or mucus-producing cellsNSCLC constitutes about 85%of al

2、l lung cancersMarketed drugs include small molecules targeting KRAS and EGFR,such as Lumakras and Tagrisso as well as monoclonal antibodies like MvasiPhase III pipeline drugs,such as bispecific or multispecific antibodies like KN046 and ivonescimab,indicate a shift towards more targeted and personal

3、ized treatment approachesThe content of this publication is proprietary to Novotech Health Holdings.No part of this publication may be reproduced,distributed,or transmitted in any form or by any means,including photocopying,recording,or other electronic or mechanical methods,without the prior writte

4、n permission of Novotech except in the case of quotations embodied in reviews and non-commercial uses.Please note that this copyright statement applies specifically to this publication and its content and does not extend to other materials or intellectual property owned by Novotech.Any unauthorized

5、reproduction or distribution of this publication or any portion thereof may result in legal action taken by Novotech to protect its rights.For permissions or inquiries,please contact:communicationsnovotech-#DYK Did youknow?In the Asia-Pacific region,China reported the highest NSCLC casesThe United S

6、tates reported the highest number of NSCLC cases in North AmericaIn Europe,Germany reported a relatively higher incidence of NSCLCIn ROW,Brazil reported the highest incidence of NSCLCTRIAL CONTRIBUTIONSNON-SMALL CELL LUNG CANCER(NSCLC)GLOBAL CLINICAL TRIAL LANDSCAPE(2024)40%ASIA-PACIFICled by Mainla

7、nd China50%NORTH AMERICA&EUROPE10%ROWIn 2022,there were an estimated 2.1 million cases of NSCLCnovotech-2NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)CONTENTS1.EPIDEMIOLOGY OVERVIEW2.STANDARD OF CARE3.GLOBAL CLINICAL TRIAL LANDSCAPE4.DRUG DISCOVERY LANDSCAPE5.FUNDING LANDSCAPE6.CU

8、RRENT ADVANCEMENTS AND FUTURE PROSPECTS7.SWOT ANALYSIS8.APPENDIXnovotech-3NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)1.EPIDEMIOLOGYDisease background Lung cancer is the second most prevalent cancer and the primary cause of mortality in the world.Non-small cell lung cancer(NSCLC)

9、,which constitutes about 85%of all lung cancers originates from larger cells,such as the epithelial cells lining the airways or mucus-producing cells.Histologically,NSCLC is classified into three types:adenocarcinoma,squamous cell carcinoma(SCC),and large cell carcinoma.Factors contributing to NSCLC

10、 include smoking,asbestos exposure,air pollution,genetic predisposition,and certain occupational exposures.(1)Approximately 30%of NSCLC patients are diagnosed at an early stage(I-IIIA),often incidentally through imaging procedures for an unrelated illness.In these early stages,the five-year recurren

11、ce rates differ,around 45%for Stage IB,62%for Stage II,and 76%for Stage III.Around 70%of NSCLC patients are diagnosed at advanced stages(locally advanced or metastatic)with survival rates of approximately 35%for locally advanced and only 7%for metastatic cases.(2)Surgery,postoperative chemotherapy,a

12、nd radiation therapy are the standard treatment options for this disease.(3)Ongoing research efforts offer promising opportunities for improving NSCLC management through the development of targeted(precision medicine)and immunotherapies.(13)This disease report offers critical information on the glob

13、al clinical trial landscape,highlighting the ongoing developments in NSCLC research.Incidence Global NSCLC Incidence Trends:This section provides an overview of the incidence of NSCLC in a selection of global locations for the year 2022(GLOBOCAN).There were approximately 2.4 million documented cases

14、 of lung cancer worldwide,out of which an estimated 2.1 million cases constituted NSCLC.Asia accounted for the largest share of NSCLC cases(63%),followed by the Western regions(30%from Europe and North America),while Latin America and the Caribbean,Africa,and Oceania accounted for the remaining(7%).

15、(4)Asia reported nearly 1.3 million cases,with China recording the highest incidence of around 0.9 million cases,representing over 40%of the global burden of NSCLC.Next Japan and India reported an incidence of 116,215 and 69,486 cases,respectively.South Korea,the Philippines,and Thailand collectivel

16、y reported an estimated NSCLC incidence of around 70,000 cases.In contrast,Malaysia and Singapore together reported over 7,000 cases.(4)Europe reported close to 0.4 million NSCLC cases,constituting 20%of the global incidence.Germany,the United Kingdom,and France reported the highest incidences,with

17、52,721,43,095,and 42,171 cases,respectively.Italy,Poland,and Spain reported comparatively lower incidences,highlighting the diverse epidemiological landscapes across Europe.(4)North America reported more than 0.2 million NSCLC cases,constituting 10%of the global incidence.The United States stands as

18、 the major contributor to NSCLC cases in this region,with over 192,000 cases reported.In addition,Canada and Mexico together reported above 30,000 cases.(4)Latin America and the Caribbean reported around 90,000 cases of NSCLC,with Brazil and Argentina contributing the majority of cases.(4)In Africa,

19、the incidence of NSCLC is relatively low compared to other regions,with approximately 42,000 cases reported.South Africa accounted for around 8,000 cases,while Egypt reported close to 6,500 cases in this region.(4)Oceania reported an estimated 15,000 NSCLC cases with Australia and New Zealand being

20、the primary contributors in this region.(4)Given the varying incidences of NSCLC across different regions,its also essential to take note of the varying lung cancer incidence rates.For example,China has the highest incidence rate at 40.8,followed by Poland at 36.5,France at 35.9,Canada at 32.4,and t

21、he United States at 31.9.(Figure 1).These statistics highlight the importance of developing region-specific strategies to combat this disease effectively worldwide.(4)novotech-4NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Table 1:Global Estimated Incidence of NSCLC,by regions(2022

22、)Table 2:Global Estimated Incidence of NSCLC in a selection of locations(2022)Source:a GLOBOCAN 2022;b is estimated from a(based on information from published scientific literature)as precise data on NSCLC incidence are not availableRegionsLung Cancer IncidenceaASIR(Lung Cancer)Estimated NSCLC Incid

23、encebPercentage of NSCLC(%)World2,480,67523.62,108,574100.0Asia1,566,35525.21,331,40263.1Europe484,30628.8411,66019.5North America257,28431.9218,69110.4Latin America and the Caribbean105,30612.189,5104.2Africa49,8316.342,3562.0Oceania17,59323.414,9540.7LocationsLung Cancer IncidenceaASIR(Lung Cancer

24、)Estimated NSCLC IncidencebPercentage of NSCLC(%)World2,480,67523.62,108,574100.0China1,060,58440.8901,49642.8United States 226,03331.9192,1289.1Japan136,72330.5116,2155.5India81,7485.869,4863.3Russia70,36226.059,8082.8Germany62,02528.152,7212.5United Kingdom50,70030.143,0952.0France49,61335.942,171

25、2.0Brazil44,21314.637,5811.8Italy43,80824.637,2371.8South Korea31,33726.226,6361.3Canada31,15732.426,4831.3Poland30,37936.525,8221.2Spain30,04127.825,5351.2Global Lung Cancer Forecast According to a recent forecast,the global incidence of lung cancer is expected to surge significantly.The GLOBOCAN d

26、ata suggests that by the year 2045,an estimated 4.3 million people globally will be diagnosed with lung cancer.This represents a substantial increase of 71.4%compared to the number of cases reported in 2022.(4)novotech-5NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Source:a GLOBOCA

27、N 2022;b is estimated from a(based on information from published scientific literature)as precise data on NSCLC incidence are not availableSource:GLOBOCAN 2022*Estimated from Lung Cancer incidence available from GLOBOCAN 2022Figure 1:Global Estimated Incidence*of NSCLC,across selected locations,2022

28、Philippines23,72824.020,1691.0Thailand23,49418.119,9700.9Australia13,42624.111,4120.5Argentina13,01619.911,0640.5South Africa9,44618.18,0290.4Mexico8,2575.47,0180.3Egypt7,6438.86,4970.3Malaysia5,50315.14,6780.2Singapore2,94024.32,4990.1New Zealand2,79627.32,3770.1novotech-6NON-SMALL CELL LUNG CANCER

29、-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Table 3:NCCN Guidelines for NSCLC,20242.STANDARD OF CAREThere have been significant improvements in the treatment of lung cancer,including advances in screening,and minimally invasive techniques for diagnosis and treatment.Radiation therapy(RT),including stereot

30、actic ablative radiotherapy(SABR)as well as new targeted therapies and immunotherapies are also available.The availability of these new treatments is associated with improved survival rates for patients with NSCLC.Biomarker testing is crucial for NSCLC patients eligible for targeted therapies or imm

31、unotherapies,guiding treatment selection and ensuring optimal outcomes,especially in advanced or metastatic stages.Treatment options for NSCLC are based on factors such as tumour histology,size and location,involvement of pleura,surgical margins,location of lymph nodes,tumour grade,and lymphovascula

32、r invasion.Patients who actively smoke should receive counseling and support for smoking cessation as they have a mild increased incidence of postoperative pulmonary complications.However,smoking status should not prevent surgery for early-stage lung cancer,as surgery remains the primary therapy.(5)

33、The table given below describes the National Comprehensive Cancer Network(NCCN)Systemic therapy guideline for NSCLC.(6)Category RecommendationEarly Stage(IA,IB,IIA,IIB)Evaluation for preoperative therapy recommended.Stage IA-Surgery is the main treatment for early-stage NSCLC.Stage IB-IIIA-Surgery f

34、ollowed by adjuvant chemotherapy with four cycles of a cisplatin-based regimen and,in cases with an EGFR exon 19 deletion or exon 21 L858R mutation,adjuvant osimertinib Stage II-IIIB-If surgically unresectable,chemoradiation plus durvalumab for one year if chemoradiation results in a partial or comp

35、lete response.Stage IV-Treatment based on histology(squamous or non-squamous)and molecular profile and biomarkers.Radiotherapy(either stereotactic ablative radiotherapy(SABR)or conventional radiotherapy)is an alternative to surgery in patients who are unable or unwilling to have surgery.In unresecta

36、ble Stage III NSCLC,chemoradiotherapy is the preferred treatment.Alternatively,chemotherapy and radiotherapy can be given sequentially(i.e.one after the other)in patients unable to tolerate concurrent treatment.Immunotherapy may be offered to some patients with unresectable locally advanced NSCLC fo

37、llowing treatment with chemoradiotherapy.Nivolumab+chemotherapy is strongly considered for tumours 4 cm or node-positive disease(if eligible for immunotherapy).Mutational Analysis Testing for EGFR,ALK,and ROS1 mutations recommended for all patients with adeno-carcinoma.EGFR-Mutant Metastatic NSCLC A

38、fatinib,Erlotinib,Gefitinib,or Osimertinib as the preferred first-line therapy options.Osimertinib generally preferred for patients with T790M mutation.Amivantamab-vmjw+carboplastin are the first line of therapy for nonsquamous EGFR Exon 20 mutation ALK-Positive Metastatic NSCLC Alectinib or Brigati

39、nib as the preferred first-line therapy options.ROS1-Positive Metastatic NSCLC Crizotinib as the preferred first-line therapy option.Adjuvant Therapy(Resected NSCLC)Cisplatin-based chemotherapy for most patients with stage II disease.Atezolizumab as an option for eligible patients with stage II-IIIA

40、 disease with specific characteristics(Refer NCCN guidelines for details).Source:NCCN Guidelines for NSCLC(Version 5.2024)Note:This table provides a high-level overview.Please refer to the full NCCN guidelines for complete and up-to-date information.novotech-7NON-SMALL CELL LUNG CANCER-GLOBAL CLINIC

41、AL TRIAL LANDSCAPE(2024)In addition to NCCN,the European Society for Medical Oncology(ESMO)publishes clinical practice guidelines to guide treatment decisions for NSCLC.The table below summarizes the ESMO recommendations for NSCLC.(7)Table 4:Systemic treatment for early and locally advanced stage NS

42、CLC,2021Category RecommendationEarly(Stage III)Adjuvant Chemotherapy after surgery is preferred.A two-drug combination is preferred(one of which is cisplatin)Locally advanced(Stage III)Intravenous cisplatin-based regimen is preferred(cisplatin-etoposide or cisplatin-vinorelbine)Chemotherapy may be g

43、iven before surgery as induction therapy(chemotherapy+/-radiotherapy)Following upfront surgery with lymph node involvement,adjuvant chemotherapy may be recommended.Unresectable Stage III NSCLC Chemotherapy concurrently with radiotherapy or sequentially(before radiotherapy)Immunotherapy-If the diseas

44、e shows no progression,Durvalumab in PD-L1 1%Metastatic(Stage IV)NSCLCChemotherapy and ImmunotherapyIn general Stage IV is treated based on histology(squamous or non-squamous),molecular profile and biomarkers.EGFR-and ALK-negativetumoursChemotherapy:Intravenous platinum-based regimen preferred(2-dru

45、g combination including cisplatin or carboplatin+gemcitabine,vinorelbine or a taxane(Good fit patients)Pemetrexed(non-squamous type)or docetaxel is recommended.Carboplatin-based regimen preferred;may be offered single-agent treatment with gemcitabine,vinorelbine or docetaxel(Less fit patients/elderl

46、y).Immunotherapy:(In patients with good general condition,no other major medical conditions)Pembrolizumab(in patients with tumours strongly positive for PD-L1)Pembrolizumab+pemetrexed and platinum-based chemotherapy(non-squamous type)Nivolumab,pembrolizumab or atezolizumab(irrespective of PD-L1 expr

47、ession)Targeted TherapyEFGR mutation Gefitinib,erlotinib,afatinib or osimertinib Erlotinib+bevacizumabBRAF mutation Dabrafenib+trametinibALK rearrangement Crizotinib,ceritinib or alectinibROS1 rearrangement CrizotinibTargeted therapy in tumours without specific mutations Bevacizumab+platinum-based r

48、egimen(non-squamous type)in patients in good general condition Erlotinib,nintedanib+docetaxel(adenocarcinoma),ramucirumab+docetaxel,afatinib are also recommendedSource:Non-small-cell lung cancer(NSCLC)An ESMO guide for patients.Note:This table provides a high-level overview based on recent ESMO guid

49、elines.Please refer to full ESMO guidelines for complete informationnovotech-8NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)The table below reflects Asia-Pacific adapted guidelines for NSCLC treatment,established in 2018.The Pan-Asian expert panel considered ethnic factors and inco

50、rporated the latest scientific evidence,building upon the ESMO guideline.(8)The below recommendations outline the treatment approaches for stage IV squamous and Non-Squamous NSCLC based on the guidelines provided by UpToDate.Table 5:Treatment of stage IV squamous and Non-Squamous NSCLCTable 6:Pan-As

51、ia Adapted ESMO Guidelines for NSCLC,2018Category RecommendationStage IV Squamous NSCLC Recommendation Cisplatin-based chemotherapy If programmed death ligand 1(PD-L1)expression is 50%,pembrolizumab alone.Stage IV Non-Squamous NSCLC If PD-L1 expression is 1-49%,cisplatin-based chemotherapy plus pemb

52、rolizumab.If PD-L1 expression is 50%,pembrolizumab alone.Cisplatin-based chemotherapy plus bevacizumab is also a reasonable option.Oral tyrosine kinase inhibitor or other targeted therapy of tumours with treatable driver mutations(eg,EGFR,ALK,ROS1,RET,BRAF,NTRK gene fusion,MET exon 14 skippings.Cate

53、gory RecommendationEarly Stage(IA,IB,IIA,IIB)Surgery with curative intent.In any stage of NSCLC,smoking cessation is highly recommended because improves the outcomes.EGFR-Mutant Metastatic NSCLC Erlotinib,Gefitinib,or Osimertinib preferred.Osimertinib preferred for T790M mutationALK-Positive Metasta

54、tic NSCLC Alectinib or BrigatinibROS1-Positive Metastatic NSCLC CrizotinibImmunotherapy(Advanced Metastatic stage)Pembrolizumab or Atezolizumab for specific populationsSource:UpToDate Overview of the initial treatment of advanced non-small cell lung cancer Source:Pan-Asian adapted ESMO Clinical Prac

55、tice Guidelines for the management of patients with metastatic non-small cell lung cancer Note:This table provides a high-level overview based on recent ESMO PAGA guidelines.Please refer to the full ESMO PAGA guidelines for complete information.novotech-9NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TR

56、IAL LANDSCAPE(2024)Source:GlobalData,April 2024 Others-Asia Pacific:Thailand,India,Malaysia,New Zealand,and the Philippines ROW:Middle East and Africa;South and Central America3.GLOBAL CLINICAL TRIAL LANDSCAPESince 2019,the global biotech and biopharmaceutical industry initiated over 5,000 clinical

57、trials for NSCLC.The Asia-Pacific region led with a trial share of 41%,followed by North America(32%),Europe(19%)and the ROW(8%).In Asia-Pacific,Mainland China accounted for the largest share of trials(40%),followed by South Korea(14%).In North America,the United States led the trials(79%).Within Eu

58、rope,Spain,France,Italy,and the United Kingdom led NSCLC trials,showing the regions contribution to advancing research.Among the ROW countries,Brazil led the NSCLC trials while Israel and Argentina showed moderate trial activity.(Refer Figures 2,3,4,5,6).(9)Figure 2:NSCLC trials%share by regionFigur

59、e 4:North America-NSCLC trials%shareFigure 6:ROW-NSCLC trials%shareFigure 3:Asia-Pacific-NSCLC trials%shareFigure 5:Europe-NSCLC trials%shareNorth AmericaUnited StatesCanadaMexicoAsia PacificEuropeRow41%32%19%8%Mainland ChinaSouth KoreaAustraliaJapanTaiwanSingaporeHong KongOthers-Asia-Pacific40%9%8%

60、11%12%14%3%3%79%16%5%SpainFranceItalyUnited KingdomGermanyBelgiumNetherlandsPolandRussiaTurkeyROE28%13%10%8%8%8%6%6%5%4%4%BrazilIsraelArgentinaChileSouth AfricaPeruColombiaOthers9%24%23%18%14%5%4%3%novotech-10NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)ROW:Includes Middle East an

61、d Africa and South and Central America ROE(excluding Russia)Others-Asia Pacific:Thailand,India,Malaysia,New Zealand,and the Philippines Source:GlobalData,April 2024Others include:Planned,Suspended,Terminated,and Withdrawn Source:GlobalData April 2024Locations where Novotech directly operates.The glo

62、bal NSCLC clinical trials landscape reflects a broad focus on advancing research for novel therapeutics to enhance treatment effectiveness.Countries like the United States,Mainland China,Spain,South Korea,and France emerged at the top in conducting trials since 2019(Refer Figure 7).These trials indi

63、cate a constant global effort towards NSCLC research,but the intensity of this effort varies across different regions and countries.(9)Since 2019,NSCLC trials have shown advancements in various regions.Asia-Pacific,North America,and Europe mostly focus on early and mid-stage development,encompassing

64、 Phases I and II.The ROW on the other hand participates to a lesser extent in different phases of the trials yet makes a moderate contribution to the overall global NSCLC research.Across North America,Asia-Pacific,Europe,and the ROW,the number of ongoing trials exceeds that of completed ones.These o

65、ngoing trials indicate sustained trial activity across all regions,showing progressive efforts in understanding the disease and treatment development efforts.(9)Figure 7:Number of Industry-initiated NSCLC Trials by Global Locations,since 2019.United StatesMainland ChinaSpainSouth KoreaFranceAustrali

66、aJapanItalyUnited KingdomGermanyMexicoCanadaHonh KongTaiwanROEPolandROWRussiaOther Asia-PacificSingaporeFigure 8:Trials by phase and region since 2019Figure 9:Trials by status and region since 2019Asia-PacificPhase ICompletedPhase IIOngoingPhase IIIOthersEuropeROWNorth Americanovotech-11NON-SMALL CE

67、LL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)*Trial density is the number of recruiting sites for industry-initiated trials per million urban population Source:GlobalData,April 2024 Patient Recruitment Landscape In terms of the patient recruitment landscape,single-country trials running in th

68、e Asia-Pacific region since 2019 have shown shorter median recruitment durations and faster recruitment rates compared to the United States(Refer Figures 11 and 12).This may be attributed to the availability of a larger and more diverse patient population which enable efficient clinical trial conduc

69、tion/execution in the region(9)Figure 10:Trial density*for industry-sponsered NSCLC,since 201914.4USEuropeAsia-Pacific5.82.0Trial Density Due to its large population and lower volume of studies,the Asia-Pacific region has lower competing trial risk with a trial density about 8 times lower than the U

70、nited States and about 3 times lower than Europe(Refer Figure 10).This indicates the potential for increased research engagement in the Asia-Pacific region.(9)15.3010.20United States0.580.29United StatesFigure 11:Enrolment period(in months),since 2019Figure 12:Subjects/Site/Month,since 2019Source:Gl

71、obalData,May 2024 Note:Europe was not included in the graph due to insufficient datanovotech-12NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Growth trends of NSCLC trials in Asia-Pacific,North America,and Europe(2014-2023)From 2014 to 2023,the Asia-Pacific region experienced the hi

72、ghest surge in trial activity,with a Compound Annual Growth Rate(CAGR)of 12.1%.Following closely,North America experienced a 5.4%increase,demonstrating a positive trend.Europe and ROW showed minimal growth rates of 1.7%and 0.9%respectively.(Figure 13)(9)Figure 13:Regional Growth Trends of NSCLC Tria

73、ls(2014-2023).Source:GlobalData,April 2024Europe:1.7%Asia-Pacific:12.1%North America:5.4%ROW 0.9%novotech-13NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)NSCLC drug development demonstrates a multi-stage pipeline,with 105 drugs in preclinical stages,121 in Phase I,250 in Phase II,a

74、nd 70 in Phase III.In addition,19 drugs have received approval,while 84 are already in the market.This distribution across different developmental stages reflects the ongoing efforts,especially in early and mid-stage drug development to improve treatments for NSCLC.(Refer Figure 14).(10)Among the li

75、st of marketed drugs classified by mechanism of action,Tubulin inhibitor,EGFR inhibitor,and RR inhibitor constitute the majority(45%)of these drugs,while DNA Synthesis inhibitor,VEGF-A inhibitor,DHFR inhibitor,and a few others account for the remaining share.In the ongoing Phase III trials,PD-1 Anta

76、gonist drugs constitute nearly 30%of the investigated drugs.The rest is distributed among categories such as CLTA-4 Antagonist,PD-L1 inhibitor,EGFR inhibitor,and a few others indicating various ongoing strategies in the field of NSCLC research.(Refer Figures 15 and 16).(9)4.DRUG DISCOVERY LANDSCAPEF

77、igure 14:No.of products by phase of developmentPreclinicalPhase IPhase IIPhase IIIApprovedMarketed1984Source:Biocentury,May 2024Note:EGFR Inhibitor:Epidermal Growth Factor Receptor Inhibitor,RR Inhibitor:Ribonucleoside Diphosphate Reductase Large Subunit Inhibitor,VEGF-A:Vascular Endothel

78、ial Growth Factor A Inhibitor,DHFR Inhibitor:Dihydrofolate Reductase Inhibitor,PD-L1 Inhibitor:Programmed Cell Death 1 Ligand 1 Inhibitor,CTLA-4 Antagonist:Cytotoxic T Lymphocyte Protein 4 Source:GlobalData,May 2024Figure 15:%Share of Marketed NSCLC Drugs by mechanism of actionFigure 16:%Share of Ph

79、ase III NSCLC Drugs by mechanism of actionTubulin InhibitorPD-1 AntagonistEGFR InhibitorCTLA-4 AntagonistRR InhibitorPD-L1 InhibitorDNA Synthesis InhibitorEGFR InhibitorVEGF-A InhibitorDNA Toposomerase I InhibitorDHFR InhibitorALKTK InhibitorALKTK InhibitorOthersPD-1 AntagonistOthers23%29%11%11%8%5%

80、5%5%3%29%37%9%8%7%6%4%novotech-14NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)From 2019 to 2023,venture capital funding for NSCLC research showed a positive trend.The United States led in funding,receiving$6841.3 million,followed closely by China with$5142.6 million.Canada,Singapo

81、re,South Korea,and Japan received$344.0 million,$158.0 million,$66.8 million,and$48.9 million,funding respectively(Refer Figure 18).These investments reflect a global effort to advance NSCLC research and development.Avistone Biotechnology Co Ltd.,Nouscom AG,and Shanghai Grit Biotechnology Inc.were a

82、mong the top companies that received funding for NSCLC research.(9)Venture Capital Funding5.FUNDING LANDSCAPENon-Governmental Organizations(NGOs)Funding for NSCLCThis section offers a comprehensive insight into NGOs funding and venture capital funding allocated to NSCLC research aimed at addressing

83、the unmet needs for treating patients with NSCLC.The Lung Cancer Research Foundation(LCRF),located in the United States,aims to address the funding disparity in lung cancer research.It provides critical seed funding totaling over$43 million across 416 grants to support early-career investigators and

84、 improve lung cancer patient outcomes through scientific discoveries.(11)In addition,the GO2 Foundation for Lung Cancer,a nonprofit organization based in the United States,provides funding for the Lung Cancer Research Program(LCRP).The LCRP operates within the Department of Defenses Congressionally

85、Directed Medical Research Programs(CDMRP).The aim is to eradicate lung cancer-related deaths and suffering,ultimately improving the health of service members,veterans,and the public.(12)The below figure shows funding received by the program from 2009 to 2023,totaling$220.5 million since its establis

86、hment.Figure 17:Funding Received by LCRP from 2009 to 2023.Source:Department of Defense Research Funding.Available from:https:/go2.org/wp-content/uploads/GO2-LCRP-2024-F-DIGITAL.pdfSource:GlobalData,May 2024Figure 18:Venture Capital Funding for NSCLC(US$m)United StatesChinaCanadaSingapore6841.35142.

87、6344.0158.0South KoreaJapan66.848.9novotech-15NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Figure 19:Average deals share%by round of financeFigure 20:Average deals share%across stage of development44%24%20%10%2%Series B Series C Series A Series D Series E+26%19%19%17%9%7%3%Preclin

88、ical Phase I Phase II Discovery Phase III IND/CTA Filed MarketedSource:GlobalData,May 2024Source:Advances in Non-Small Cell Lung Cancer(NSCLC)TreatmentA Paradigm Shift in Oncology,DOI:https:/doi.org/10.3390/ph17020246In recent years,the field of NSCLC treatment has undergone significant advancements

89、 to address this challenging disease.From targeted therapies targeting genetic mutations to novel immunotherapy strategies that help the bodys immune system fight cancer,NSCLC treatment has evolved significantly.These advancements provide hope for patients by offering more precise and effective trea

90、tment options personalized to the unique molecular characteristics of their cancer.(13)Companies like AstraZeneca,Genoptix,and Merck are developing various innovative therapies for NSCLC.(10)The below figure lists the recent advancements and therapies used in the treatment of NSCLC.In conclusion,rec

91、ent advances in the field of NSCLC have paved the way for a better understanding of this complicated disease.Advancements in targeted therapy,immunotherapy,precision medicine,and emerging technologies have significantly improved the outlook for patients with NSCLC.Collaborations among researchers,an

92、d biotech industries,associated costs,and long-term effects are crucial for exploring these innovative therapies and technologies to improve NSCLC care.(13)6.CURRENT ADVANCEMENTS AND FUTURE PROSPECTS From 2019 to 2023,NSCLC research and development have secured significant financial support,particul

93、arly in Series B and Series C funding rounds,showing potential for advancement in addressing this disease.Approximately half of the funding was allocated to preclinical and phase I stages,with a slight decrease in investment during phase II and the discovery stage.In contrast,Phase III,IND/CTA filed

94、,and Marketed stages received smaller shares.This reflects the decreased need for external investment as the drug progresses towards commercialization.(Refer Figures 19 and 20).(9)Figure 21:Advancements in NSCLC Treatmentnovotech-16NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)The

95、SWOT analysis section focuses on evaluating strengths,weaknesses,opportunities,and threats in NSCLC drug development.It systematically assesses internal and external factors,helping healthcare professionals optimize treatment strategies,address challenges,exploit opportunities,and enhance care for i

96、ndividuals with this disease.(13)7.SWOT ANALYSISStrengthWeaknesses Understanding genetic mutations in NSCLC has led to targeted therapies like EGFR and ALK inhibitors,offering precise treatment options.Immunotherapy,particularly with PD-1 inhibitors like Pembrolizumab offers prolonged survival and e

97、nhanced patient quality of life.Despite targeted therapies and immunotherapy,resistance mechanisms remain a challenge,necessitating ongoing research.Developing strategies to overcome tumor heterogeneity poses a challenge in ensuring effective treatment for all patients.OpportunitiesThreats Identific

98、ation of new targets like NRGs,CLIP-LTK,and DDRs presents opportunities for developing effective therapies for advanced NSCLC lacking known driver mutations.Investigating combinations of checkpoint inhibitors with chemotherapy or targeted agents holds promise Ensuring access to advanced treatments w

99、hile addressing cost challenges and equitable NSCLC management.Quality of life for NSCLC patients is impacted by the side effects and toxicity of standard treatments like chemotherapy and targeted therapiesAnalysis SummaryOngoing research efforts have led to advancements in NSCLC treatment,including

100、 targeted therapies and immunotherapy,which have improved patient outcomes.However,challenges such as treatment resistance and tumor heterogeneity persist.Collaborative efforts among researchers and pharmaceutical companies have enhanced treatment strategies,but addressing access barriers and managi

101、ng treatment-related side effects are crucial for enhancing patient quality of life.Source:Advances in Non-Small Cell Lung Cancer(NSCLC)TreatmentA Paradigm Shift in Oncology,DOI:https:/doi.org/10.3390/ph17020246novotech-17NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)The table belo

102、w is a comprehensive list of drugs related to NSCLC,including those that are currently available in the market and in the Phase III development stage.Marketed drugs include small molecules targeting KRAS and EGFR,such as Lumakras and Tagrisso(Osimertinib)as well as monoclonal antibodies like Mvasi(b

103、iosimilar bevacizumab)Phase III pipeline drugs,such as bispecific or multispecific antibodies like KN046 and ivonescimab,indicate a shift towards more targeted and personalized treatment approaches.(10)8.APENDIXTable 7.Marketed and Pipeline drugs for NSCLC.Company Name(Originator)Product NameTargets

104、Therapeutic ModalitiesPhase of DevelopmentAdvanz Pharma Corp.Ltd.Photobarr,Photofrin,porfimer sodiumNot applicablePhotodynamic therapyMarketedAmgen Inc.Lumakras,Lumykras,sotorasib(AMG 510)KRAS proto-oncogene,GTPase(KRAS)(K-Ras)Small moleculeMarketedAmgen Inc.Mvasi,biosimilar bevacizumab(ABP 215)Vasc

105、ular endothelial growth factor(VEGF)AntibodyMarketedApac Biotech Pvt.Ltd.ApcedenUndisclosedTherapeutic vaccineMarketedAstellas Pharma Inc.Tarceva,erlotinib(R1415,RG115,CP-358,774,OSI-774)Epidermal growth factor receptor(EGFR)(ErbB1)(HER1)Small moleculeMarketedAstraZeneca plcIressa,gefitinib(ZD1839)E

106、pidermal growth factor receptor(EGFR)(ErbB1)(HER1)Small moleculeMarketedAstraZeneca plcTagrisso,osimertinib(AZD9291)Epidermal growth factor receptor(EGFR)(ErbB1)(HER1)Small moleculeMarketedBeiGene Ltd.Tevimbra,tislelizumab(BGB-A317,VDT482)Fc gamma receptor(FCGR);Programmed cell death 1(PD-1)(PDCD1)(

107、CD279)AntibodyMarketedBetta Pharmaceuticals Co.Ltd.Conmana,icotinib(BPI-2009C,BPI-2009H)Epidermal growth factor receptor(EGFR)(ErbB1)(HER1)Small moleculeMarketedBiocad CJSCAvegra,bevacizumab biosimilar(BCD-021)Vascular endothelial growth factor(VEGF)AntibodyMarketedBio-Thera Solutions Ltd.Pobevcy,be

108、vacizumab biosimilar(BAT1706)Vascular endothelial growth factor(VEGF)AntibodyMarketedBlueprint Medicines Corp.Gavreto,pralsetinib(BLU-667,CS3009,RG6396)Ret proto-oncogene(RET)Small moleculeMarketedBoehringer Ingelheim GmbHGilotrif,Giotrif,afatinib(bibw 2992,tomtovok,Tovok)Epidermal growth factor rec

109、eptor(EGFR)(ErbB1)(HER1);Epidermal growth factor receptor 4(EGFR4)(HER4)(ErbB4);Epidermal growth factor receptor 2(HER2)(EGFR2)(ErbB2)(neu)Small moleculeMarketedBoehringer Ingelheim GmbHOfev,Vargatef,nintedanib(BIBF 1120)Vascular endothelial growth factor(VEGF)receptor;Platelet derived growth factor

110、 receptor(PDGFR)Small moleculeMarketedBristol Myers Squibb Co.Abraxane,nab-paclitaxel(ABI-007)TubulinSmall moleculeMarketedChugai Pharmaceutical Co.Ltd.Alecensa,Alecensaro,alectinib(AF802,CH5424802,RG7853,RO5424802)Anaplastic lymphoma kinase(ALK)Small moleculeMarketedEli Lilly and Co.Cyramza,ramucir

111、umab(IMC-1121B,LY3009806)Vascular endothelial growth factor(VEGF)receptor 2(VEGFR-2)(KDR/Flk-1)AntibodyMarketed3SBio Inc.biosimilar bevacizumab(SB8)Vascular endothelial growth factor(VEGF)AntibodyPhase IIIAbbVie Inc.Teliso-V,telisotuzumab vedotin(ABBV-399)c-Met receptor tyrosine kinase(c-MET)(MET)(H

112、GFR)Antibody-drug conjugatePhase IIIAbbVie Inc.veliparib(ABT-888)Poly(ADP-ribose)polymerase(PARP)Small moleculePhase IIIAkeso Inc.ivonescimab(AK112)Programmed cell death 1(PD-1)(PDCD1)(CD279);Vascular endothelial growth factor(VEGF)Bispecific or multispecific antibodyPhase IIIAlphamab Oncology Ltd.K

113、N046Programmed cell death 1 ligand 1(PD-L1)(B7-H1)(CD274);Cytotoxic T-lymphocyte associated protein 4(CTLA-4)(CTLA4)(CD152)Bispecific or multispecific antibodyPhase IIInovotech-18NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Amgen Inc.Aranesp,Nesp,darbepoetin alfa(KRN321,Nespo,nove

114、l erythropoiesis stimulating protein(NESP)Erythropoietin(EPO)receptor(EpoR)ProteinPhase IIIAnaptysBio Inc.cobolimab(GSK4069889,TSR-022)T cell immunoglobulin and mucin domain 3(TIM3)(HAVCR2)AntibodyPhase IIIArcus Biosciences Inc.domvanalimab(AB154)T cell immunoreceptor with Ig and ITIM domains(TIGIT)

115、AntibodyPhase IIIAstraZeneca plcLynparza,olaparib(AZD2281,KU-0059436,MK-7339)Poly(ADP-ribose)polymerase(PARP)Small moleculePhase IIIBeiGene Ltd.Ociperlimab(BGB-A1217)T cell immunoreceptor with Ig and ITIM domains(TIGIT)AntibodyPhase IIIBeijing Sailin Tai Pharmaceutical Technology Co.Ltd.CT-707Phase

116、IIIBiocad CJSCProlgolimab(BCD-100)Programmed cell death 1(PD-1)(PDCD1)(CD279)AntibodyPhase IIIBioNumerik Pharmaceuticals Inc.Tavocept(BNP7787)DNASmall moleculePhase IIIBioven Ltd.BV-NSCLC-001Epidermal growth factor receptor(EGFR)(ErbB1)(HER1)Peptide vaccinePhase IIIBoehringer Ingelheim GmbHbiosimila

117、r bevacizumab(BI 695502)Vascular endothelial growth factor(VEGF)AntibodyPhase IIIBristol Myers Squibb Co.Ilaris,canakinumab(ACZ885)Interleukin-1(IL-1)betaAntibodyPhase IIIBristol Myers Squibb Co.Sitravatinib(MGCD516,mg516)TYRO3 protein tyrosine kinase(TYRO3)(Sky);Ret proto-oncogene(RET)Small molecul

118、ePhase IIICheckpoint Therapeutics Inc.cosibelimab(TG-1501,CK-301)Programmed cell death 1 ligand 1(PD-L1)(B7-H1)(CD274)AntibodyPhase IIIChong Kun Dang Pharmaceutical Corp.Camtobell,belotecan(CKD-602)Topoisomerase I(TOP1)Small moleculePhase IIIDaiichi Sankyo Co.Ltd.patritumab(AMG 888,U3-1287)Erb-b2 re

119、ceptor tyrosine kinase 3 (HER3)(ERBB3)(EGFR3)AntibodyPhase IIIDr.Reddys Laboratories Ltd.CA-170(AUPM-170)V-region immunoglobulin-containing suppressor of T cell activation(VISTA);Programmed cell death 1 ligand 1(PD-L1)(B7-H1)(CD274)Small moleculePhase IIIEisai Co.Ltd.Halaven,Teceris,eribulin mesylat

120、e(E7389)Tubulin polymeraseSmall moleculePhase IIIEli Lilly and Co.Verzenio,abemaciclib(LY2835219)Cyclin dependent kinase 4(CDK4);Cyclin dependent kinase 6(CDK6)Small moleculePhase IIISource:Biocentury,May 2024novotech-19NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)1.Dela Cruz CS,T

121、anoue LT,Matthay RA.Lung Cancer:Epidemiology,Etiology,and Prevention.Clin Chest Med.2011 Dec;32(4):60544.2.Lim JU Update on Adjuvant Treatment in Resectable Non-Small Cell Lung Cancer and Potential Biomarkers Predicting Postoperative Relapse.Tuberc Respir Dis(Seoul).2023 Jan 1;86(1):1422.3.Non-Small

122、 Cell Lung Cancer Treatment.Available from:https:/www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq4.GLOBOCAN,20225.Non-Small Cell Lung Cancer Treatment.Available from:https:/www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq6.Kristina Gregory N,Lisa Hang M,Aisner DL,Akerley

123、 W,Bauman JR,Bruno DS,et al.NCCN Guidelines Version 5.2024 Non-Small Cell Lung Cancer Continue NCCN Guidelines Panel Disclosures Internet.2024.Available from:https:/www.nccn.org/home/member-7.Society for Medical Oncology E.Non-Small-Cell Lung Cancer ESMO Patient Guide Series based on the ESMO Clinic

124、al Practice Guidelines.8.Wu YL,Planchard D,Lu S,Sun H,Yamamoto N,Kim DW,et al.Pan-asian adapted clinical practice guidelines for the management of patients with metastatic non-small-cell lung cancer:A csco-esmo initiative endorsed by jsmo,ksmo,mos,sso and tos.Vol.30,Annals of Oncology.Oxford Univers

125、ity Press;2019.p.171210.9.GlobalData,April,May 2024 10.Biocentury,May 202411.Lung Cancer Research Foundation.Available from:https:/www.lungcancerresearchfoundation.org/research/why-research/12.GO2 for Lung Cancer.Available from:https:/go2.org/wp-content/uploads/GO2-LCRP-2024-F-DIGITAL.pdf13.Advances

126、 in Non-Small Cell Lung Cancer(NSCLC)TreatmentA Paradigm Shift in Oncology.References:NOTE:GlobalDatas Clinical Trials Intelligence gathers data from a mix of primary and secondary sources to offer comprehensive insights for stakeholders involved in drug development and clinical research.Primary res

127、earch contributions include exclusive insights from journalists covering developments only available on the GlobalData platform.Secondary sources include over 100 clinical trials registries like ClinicalTrials.gov(Global),EudraCT/EUCTR(Europe),JAPIC/UMIN(Japan),CTRI(India),ChiCTR(China),and more,alo

128、ngside company sources such as press releases,financial statements,SEC filings,investor presentations,and pipeline information from company webpages.Information is also sourced from over 200 scientific conferences like ASCO,investor conferences such as the Annual JP Morgan Healthcare Conference,regu

129、latory authorities including the USFDA,EMA,UKMHRA,and academic publications from journals and PubMed.Supported by more than 100 dedicated researchers,GlobalDatas platform is a vital resource for pharmaceutical companies,biotech firms,and other stakeholders,helping them stay updated on the latest tre

130、nds and developments in the clinical trials landscape for better decision-making.novotech-20NON-SMALL CELL LUNG CANCER-GLOBAL CLINICAL TRIAL LANDSCAPE(2024)Founded in 1997,Novotech is a global full-service clinical Contract Research Organization(CRO)focused on partnering with biotech companies to ac

131、celerate the development of advanced and novel therapeutics at every phase.Recognized for its industry-leading contributions,Novotech has received numerous prestigious awards,including the CRO Leadership Award 2023,the Asia Pacific Cell&Gene Therapy Clinical Trials Excellence 2023,the Asia-Pacific C

132、ontract Research Organization Company of the Year Award since 2006.The Company offers a comprehensive suite of services including laboratories,Phase I facilities,drug development consulting,regulatory expertise,and has experience with over 5,000 clinical projects,including Phase I to Phase IV clinic

133、al trials and bioequivalence studies.With a presence in 34 office locations and a dedicated team of 3,000+professionals worldwide,Novotech is a trusted end-to-end strategic partner of choice.For more information,visit https:/novotech- The content of this publication is proprietary to Novotech Health

134、 Holdings.No part of this publication may be reproduced,distributed,or transmitted in any form or by any means,including photocopying,recording,or other electronic or mechanical methods,without the prior written permission of Novotech except in the case of quotations embodied in reviews and non-comm

135、ercial uses.Please note that this copyright statement applies specifically to this publication and its content and does not extend to other materials or intellectual property owned by Novotech.Any unauthorized reproduction or distribution of this publication or any portion thereof may result in legal action taken by Novotech to protect its rights.For permissions or inquiries,please contact:communicationsnovotech-novotech-