美国目前已经进入临床阶段的在研肺癌药物一览
本帖最后由 costa_na 于 2014-10-13 20:40 编辑PhRMA全称为The Pharmaceutical Research and Manufacturers of America(美国药物研究和制造商协会)，是全球知名的药品研究与制造商协会，总部设在华盛顿，由美国领先的制药和生物技术研究公司组成，致力于发明新的药物，使患者的存活时间更长，更健康，更具生活质量。公司的主要任务是作为集体参与美国医药公共政策的制定，对医药行业争取利润空间，同时对医药政策进行宣传。
资料来源是PhRMA发布的2014 Cancer report，提取了其中关于肺癌的在研药品信息：
产品名称(Product Name) 制造商(Sponsor) 适应症(Indication) 在研阶段(Development Phase)
abemaciclib
(CDK 4/6 inhibitor)Lilly
Indianapolis, INnon-small-cell lung cancer (NSCLC)
(see also breast, lymphoma)
Phase I
www.lilly.com
ABT-RTA-408AbbVie
North Chicago, IL
Reata Pharmaceuticals
Irving, TX metastatic NSCLC
(see also skin)Phase I
www.abbvie.com
www.reatapharma.com
ADI-PEG 20
(PEG arginine deiminase)Polaris Pharmaceuticals
San Diego, CAsmall-cell lung cancer (SCLC)
(see also breast, leukemia, liver, lymphoma, skin)
--------------------------------
mesothelioma, NSCLCPhase II
www.polarispharma.com
--------------------------------
Phase I
www.polarispharma.com
A finitor®
everolimus Novartis Pharmaceuticals
East Hanover, NJ neuroendocrine lung tumors
(see also breast, lymphoma, stomach) Phase III
www.novartis.com
aldoxorubicin
(delivery-enhanced doxorubicin) CytRx
Los Angeles, CA SCLC
(see also brain, sarcoma) Phase II
www.cytrx.com
alectinib
(ALK inhibitor) Chugai Pharma USA
Berkeley Heights, NJ
Roche
Basel, Swizterland NSCLC
(Breakthrough Therapy) Phase II
www.chugai-pharm.com
www.roche.com
alisertib
(auroura A kinase inhibitor) Millennium Pharmaceuticals
Cambridge, MA SCLC
(see also lymphoma, ovarian) Phase II
www.millennium.com
antroquinonol Golden Biotechnology
New Taipei City, Taiwan NSCLCPhase II
www.goldenbiotech.com.tw
AP26113
(ALK inhibitor) ARIAD Pharmaceuticals
Cambridge, MANSCLC Phase II
www.ariad.com
apatorsen
(Hsp27 inhibitor) OncoGenex Pharmaceuticals
Bothell, WA non-squamous NSCLC, squamous NSCLC
(see also bladder, pancreatic, prostate) Phase II
www.oncogenex.com
ASP8273 Astellas Pharma US
Northbrook, IL NSCLC Phase I/II
www.astellas.com
AT13387
(HSP90 inhibitor) Astex Pharmaceuticals
Dublin, CANSCLC
(see also skin) Phase II
www.astx.com
Avastin®
bevacizumab Genentech
South San Francisco, CA NSCLC (adjuvant)
(see also brain, ovarian, other) Phase III
www.gene.com
AZD9291
(EGFR tyrosine kinase inhibitor) AstraZeneca
Wilmington, DE advanced T790M mutation-positive NSCLC
(Breakthrough Therapy) Phase II/III
www.astrazeneca.com
bavituximab Peregrine Pharmaceuticals
Tustin, CA NSCLC (2nd-line)
(see also breast, liver, skin, other)
--------------------------------
NSCLC (1st-line) Phase III
www.peregrineinc.com
--------------------------------
Phase I
www.peregrineinc.com
BBI608
(cancer stemness kinase inhibitor) Boston Biomedical
Cambridge, MA NSCLC
(see also breast, colorectal, ovarian, skin, stomach) Phase I/II
www.bostonbiomedical.com
belinostat Spectrum Pharmaceuticals
Henderson, NV NSCLC Phase I/II
www.sppirx.com
bevacizumab biosimilar Actavis
Parsippany, NJ
Amgen
Thousand Oaks, CA NSCLC Phase III
www.actavis.com
www.amgen.com
BIND-014
(PSMA-targeted docetaxel) BIND Therapeutics
Cambridge, MA NSCLC
(see also prostate) Phase II
www.bindtherapeutics.com
CRS-207
(cancer immunotherapy) Aduro BioTech
Berkeley, CA mesothelioma (combination therapy)
(see also pancreatic) Phase I
ww.adurobiotech.com
custirsen (OGX-111)
(antisense oligonucleotide) OncoGenex Pharmaceuticals
Bothell, WA
Teva Pharmaceutical
Frazier, PA NSCLC (Fast Track)
(see also prostate) Phase III
www.oncogenex.com
www.tevapharm.com
Cynviloq™
paclitaxel polymeric micelle for injection Sorrento Therapeutics
San Diego, CA NSCLC
(see also bladder, breast, ovarian, pancreatic) Phase III
www.sorrentotherapeutics.com
Cyramza®
ramucirumab Lilly
Indianapolis, IN NSCLC (combination therapy)
(see also bladder, breast, colorectal, liver, ovarian, solid tumors, stomach)
Phase III
www.lilly.com
CYT-6091
(nanomedicine) CytImmune Sciences
Rockville, MD NSCLC (2nd-line) Phase II
www.cytimmune.com
dacomitinib
(pan-HER inhibitor) Pfizer
New York, NY EGFR-mutant NSCLC (1st-line)
(see also solid tumors) Phase III
www.p fizer.com
DKN-01
(DKK1 protein inhibitor) HealthCare Pharmaceuticals
Cambridge, MA NSCLC
(see also myeloma, other) Phase I
www.healthcarepharmaceuticals.com
DPV-001
(toll-like receptor agonist) UbiVac
Portland, OR NSCLC Phase II
www.ubivac.com
E7080
(multi-targeted kinase inhibitor) Eisai
Woodcli Lake, NJ NSCLC (3rd-line monotherapy), NSCLC (RET translocations)
(see also brain, liver, skin, other) Phase II
www.eisai.com
EGF816
(EGFR TK inhibitor) Novartis Pharmaceuticals
East Hanover, NJ NSCLC Phase I/II
www.novartis.com
ficlatuzumab
(HGF/c-MET inhibitor) AVEO Oncology
Cambridge, MA NSCLC Phase II
www.aveooncology.com
foretinib
(c-MET kinase inhibitor) GlaxoSmithKline
Research Triangle Park, NC NSCLC Phase II
www.gsk.com
ganetespib
(Hsp90 inhibitor) Synta Pharmaceuticals
Lexington, MA NSCLC
(Fast Track)
(see also breast, leukemia, ovarian) Phase III
www.syntapharma.com
GI-4000
(natural killer cell stimulant) GlobeImmune
Louisville, CO NSCLC
(see also pancreatic) Phase II
www.globeimmune.com
GL-ONC1
(oncolytic virus immunomodulator) Genelux
San Diego, CA lung, malignant mesothelioma
(see also head/neck, solid tumors, other) Phase I
www.genelux.com
GSK2879552
(LSD1/CoREST inhibitor) GlaxoSmithKline
Research Triangle Park, NC relapsed/refractory SCLC Phase I
www.gsk.com
Halaven®
eribulin Eisai
Woodcli Lake, NJ NSCLC
(see also breast, sarcoma) Phase III
www.eisai.com
Imprime PGG®
intravenous immunostimulant Biothera
Eagan, MN metastatic NSCLC (1st-line)
(see also colorectal, leukemia, lymphoma, pancreatic) Phase II
www.biothera.com
INCB24360
(IDO1 inhibitor) Incyte
Wilmington, DE NSCLC
(see also ovarian, skin, other) Phase I/II
www.incyte.com
INCB39110
(JAK1 inhibitor) Incyte
Wilmington, DENSCLC
(see also solid tumors)Phase I/II
www.incyte.com
ISIS-EIF4ERX
(antisense oligonucleotide) Isis Pharmaceuticals
Carlsbad, CA NSCLC
(see also prostate) Phase II
www.isispharm.com
Jaka fi®
ruxolitinibIncyte
Wilmington, DENSCLC
(see also breast, colorectal, pancreatic, other)Phase I
www.incyte.com
KD019
(TKI inhibitor) Kadmon Pharmaceuticals
Warrendale, PA NSCLC
(see also breast)
--------------------------------
Src-positive NSCLC Phase II
www.kadmon.com
--------------------------------
Phase I
www.kadmon.com
KD032
(Ras antagonist) Kadmon Pharmaceuticals
Warrendale, PA NSCLC
(see also colorectal, pancreatic) Phase II
www.kadmon.com
Keytruda®
pembrolizumab Merck
Whitehouse Station, NJ NSCLC
(see also bladder, breast, head/neck, hematological, kidney, myeloma, stomach) Phase III
www.merck.com
Kyprolis®
car lzomab Onyx Pharmaceuticals
South San Francisco, CA SCLC
(see also myeloma) Phase II
www.onyx.com
lifastuzumab vedotin
(anti-NaPi2b antibody drug conjugate)
(RG7599) Genentech
South San Francisco, CA NSCLC
(see also ovarian) Phase I
www.gene.com
lucitanib
(FGFR/VEGFR/PDGFR inhibitor) Clovis Oncology
Boulder, CO squamous NSCLC
(see also breast) Phase II
www.clovisoncology.com
lung cancer DNA vaccine
(IC 1001) Immune Cell Therapy
Chicago, IL NSCLC Phase I
www.immcellther.com
LY2510924
(CXCR4 peptide antagonist) Lilly
Indianapolis, IN SCLC
(see also kidney) Phase II
www.lilly.com
LY2875358
(c-Met mAb)Lilly
Indianapolis, IN NSCLC
(see also stomach)Phase II
www.lilly.com
LY2940680
(hedgehog/SMO antagonist)Lilly
Indianapolis, IN SCLCPhase I/II
www.lilly.com
MAGE-A3 immunotherapeutic
(recombinant antigen-speci c cancer immunotherapeutic) GlaxoSmithKline
Research Triangle Park, NC NSCLC Phase III
www.gsk.com
ME-344
(mitochondrial inhibitor) MEI Pharma
San Diego, CA SCLC
(see also ovarian) Phase I
www.meipharma.com
MEDI4736
(anti-PD-L1 mAb) MedImmune
Gaithersburg, MD stage III NSCLC, NSCLC (3rd-line) Phase III
www.medimmune.com
MEDI4736 + Iressa® ge fitinib
(anti-PD-L1 mAb/EGFR inhibitor)MedImmune
Gaithersburg, MD NSCLCPhase I
www.medimmune.com
MGCD265
(MET/Axl/VEGFR kinase inhibitor) Mirati Therapeutics
San Diego, CA NSCLC
(see also head/neck) Phase I
www.mirati.com
MM-121
(ErbB-3 receptor antagonist) Merrimack Pharmaceuticals
Cambridge, MA NSCLC
(see also breast, ovarian) Phase II
www.merrimackpharma.com
MORAb-003
(IgG1 mAb) Eisai
Woodcli Lake, NJ
Morphotek
Exton, PA NSCLC
(see also ovarian) Phase II
www.eisai.com
MORAb-009
(megakaryocyte potentiating factor inhibitor)
ORPHAN DRUG
Eisai
Woodcli Lake, NJ
Morphotek
Exton, PA mesothelioma
--------------------------------
solid tumorsPhase II
www.eisai.com
--------------------------------
Phase I
www.eisai.com
NC-6004
(nanoparticle cisplatin) NanoCarrier
Tokyo, Japan NSCLC Phase I/II
www.nanocarrier.co.jp
necitumumab
(EGFR inhibitor) Lilly
Indianapolis, IN squamous NSCLC Phase III
www.lilly.com
nivolumab
(PD-1 inhibitor) Bristol-Myers Squibb
Princeton, NJ NSCLC (1st-line), squamous NSCLC (2nd-line), non-squamous NSCLC (2nd-line)
(see also brain, colorectal, head/neck, hematological, kidney, liver, lymphoma, skin, solid tumors)
--------------------------------
squamous NSCLC (3rd-line)
--------------------------------
NSCLC, SCLC Phase III
www.bms.com
--------------------------------
Phase II
www.bms.com
--------------------------------
Phase II
www.bms.com
nivolumab + Yervoy®
ipilimumab Bristol-Myers Squibb
Princeton, NJ NSCLC, SCLC
(see also brain, colorectal, head/neck, hematological, kidney, skin) Phase I
www.bms.com
patritumab
(anti-HER3 antibody) Daiichi Sankyo
Parsippany, NJ NSCLC
(see also breast) Phase II
www.dsi.com
PDT with Photofrin®
por fimer sodium
ORPHAN DRUG Pinnacle Biologics
Bannockburn, IL epithelioid malignant pleural
mesothelioma
(see also liver) Phase III
www.pinnaclebiologics.com
pelareorep
Oncolytics Biotech
Calgary, Canada NSCLC, squamous cell carcinoma of the lung
(see also colorectal, head/neck, myeloma, ovarian, pancreatic, skin, solid tumors, other) Phase II
www.oncolyticsbiotech.com
pictrelisib
(PI3K inhibitor) Genentech
South San Francisco, CA metastatic NSCLC
(see also breast) Phase II
www.gene.com
PRAME immunotherapeutic
(recombinant antigen-speci fic cancer immunotherapeutic) GlaxoSmithKline
Research Triangle Park, NC resectable NSCLC
Phase II
www.gsk.com
PT 107
(allogeneic B7.1/HLA-A1 transfected tumor cell vaccine) Pique Therapeutics
Durham, NC NSCLC Phase II
www.piquetherapeutics.com
RG7446
(anti-PD-L1 mAb) Genentech
South San Francisco, CA NSCLC (2nd-line)
(see also bladder, kidney, skin)
--------------------------------
NSCLC (3rd-line)
--------------------------------
EGFR-positive NSCLC
Phase III
www.gene.com
--------------------------------
Phase II
www.gene.com
--------------------------------
Phase I
www.gene.com
rociletinib (CO-1686)
(EGFR inhibitor) Clovis Oncology
Boulder, CO EGFR-mutated NSCLC
(Breakthrough Therapy) Phase II
www.clovisoncology.com
roniciclib
(CDK inhibitor) Bayer HealthCare Pharmaceuticals
Whippany, NJ SCLCPhase II
www.bayerpharma.com
sapacitabine
ORPHAN DRUG Cyclacel Pharmaceuticals
Berkeley Heights, NJ NSCLC
(see also hematological, leukemia) Phase II
www.cyclacel.com
SC16LD6.5
(antibody drug conjugate) Stem CentRx
South San Francisco, CA SCLCPhase I/II
www.stemcentrx.com
seliciclib
(CDK inhibitor) Cyclacel Pharmaceuticals
Berkeley Heights, NJ NSCLC
(see also other) Phase II
www.cyclacel.com
selumetinib
(MEK inhibitor) Array BioPharma
Boulder, CO
AstraZeneca
Wilmington, DE KRAS-positive NSCLC (2nd-line)
(see also other)
--------------------------------
KRAS-negative NSCLC (2nd-line)
Phase III
www.arraybiopharma.com
www.astrazeneca.com
--------------------------------
Phase III
www.arraybiopharma.com
www.astrazeneca.com
SPI-1620
(endothelin B receptor agonist) Spectrum Pharmaceuticals
Henderson, NV NSCLC
(see also liver) Phase II
www.sppirx.com
Ta finlar®
dabrafenib GlaxoSmithKline
Research Triangle Park, NC NSCLC
(Breakthrough Therapy) Phase II
www.gsk.com
tarextumab
(anti-NOTCH 2/3) OncoMed Pharmaceuticals
Redwood City, CA SCLC
(see also pancreatic) Phase I/II
www.oncomed.com
Tavocept™ BioNumerik Pharmaceuticals
San Antonio, TX lung cancer Phase III
www.bionumerik.com
tergenpumatucel-L NewLink Genetics
Ames, IA advanced or metastatic NSCLC Phase II/III
www.newlinkgenetics.com
TG4010
(MVA-MUC1-IL2 cancer vaccine) Transgene
Cambridge, MA advanced NSCLC Phase II/III
www.transgene.fr
TH-302
(hypoxia-activated prodrug) EMD Serono
Rockland, MA
Threshold Pharmaceuticals
South San Francisco, CA NSCLC
(see also hematological, pancreatic, skin, sarcoma, solid tumors) Phase II
www.emdserono.com
www.thresholdpharm.com
topotecan liposomal
Spectrum Pharmaceuticals
Henderson, NV lung cancer
(see also breast) Phase I
www.sppirx.com
tremelimumab
(anti-CTLA-4 mAb) MedImmune
Gaithersburg, MD mesothelioma Phase III
www.medimmune.com
tremelimumab
(anti-CTLA-4 mAb)/Iressa® ge tinib combination AstraZeneca
Wilmington, DE
MedImmune
Gaithersburg, MD NSCLC Phase I
www.astrazeneca.com
www.medimmune.com
TSR-011
(ALK/TRK inhibitor) TESARO
Waltham, MA NSCLC Phase I/II
www.tesarobio.com
TUSC2
(gene therapy) Genprex
Austin, TX NSCLC Phase I/II
www.genprex.com
Vargatef™
nintedanib Boehringer Ingelheim Pharmaceuticals
Ridge eld, CT NSCLC
(see also ovarian)
--------------------------------
mesothelioma Phase III
www.boehringer-ingelheim.com
--------------------------------
Phase II
www.boehringer-ingelheim.com
veliparib AbbVie
North Chicago, IL NSCLC
(see also brain, breast) Phase III
www.abbvie.com
viagenpumatucel-L
(cancer immunotherapy) Heat Biologics
Durham, NC NSCLC Phase II
www.heatbio.com
vinorelbine liposomal
Spectrum Pharmaceuticals
Henderson, NV SCLC
(see also ovarian) Phase I
www.sppirx.com
vintafolide
(folate-DAVLBH) Endocyte
West Lafayette, IN NSCLC
(see also solid tumors) Phase II
www.endocyte.com
VS-6063
(FAK inhibitor)
ORPHAN DRUG Verastem
Cambridge, MA KRAS-mutant NSCLC, mesothelioma
(see also ovarian) Phase II
www.verastem.com
Xalkori®
crizotinib
ORPHAN DRUG P fizer
New York, NY ALK-positive NSCLC (1st-line)
(see also solid tumors) Phase III
www.pfizer.com
Xgeva®
denosumab Amgen
Thousand Oaks, CA metastatic NSCLC (1st-line)
(see also breast) Phase II
www.amgen.com
Yervoy®
ipilimumab Bristol-Myers Squibb
Princeton, NJ SCLC (1st-line), squamous NSCLC (1st-line)
(see also ovarian, prostate, skin, stomach) Phase III
www.bms.com
Zykadia™
ceritinib Novartis Pharmaceuticals
East Hanover, NJ ALK-positive advanced NSCLC
(1st-line, treatment naïve) Phase II
www.novartis.com
source: http://www.phrma.org/sites/default/files/pdf/2014-cancer-report.pdf 感谢costa_na！我们又看到希望啦{:soso_e100:} {:soso_e160:} 谢谢COAST分享 期待ING 这得多少药，如果大都能轮换有效的话，病友有福了。 不知有多少药能有明显的作用。 这仅是美国的吗？那么我想其他国家是不是应该也会有一些，希望能早日研发出有效的药物 本帖最后由 yuzhou05 于 2014-10-15 10:16 编辑
网上找的几个fast track和 breakthrough 药的简单介绍。
AZD9291 就不说了，帖子已经很多了。
Dabrafenib (trade name Tafinlar) is a drug for the treatment of cancers associated with a mutated version of the gene BRAF. Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth. Dabrafenib has clinical activity with a manageable safety profile in clinical trials of phase 1 and 2 in patients with BRAF(V600)-mutated metastatic melanoma.
The Food and Drug Administration approved dabrafenib as a single agent treatment for patients with BRAF V600E mutation-positive advanced melanoma on May 30, 2013. Clinical trial data demonstrated that resistance to dabrafinib and other BRAF inhibitors occurs within 6 to 7 months. To overcome this resistance, the BRAF inhibitor dabrafenib was combined with the MEK inhibitor trametinib. As a result of this research, on January 8, 2014, the FDA approved the combination of dabrafenib and trametinib for the treatment of patients with BRAF V600E/K-mutant metastatic melanoma.
Rociletinib (CO-1686) is a novel, oral, targeted covalent (irreversible) inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR) currently being studied for the treatment of non-small cell lung cancer (NSCLC). Rociletinib was designed to selectively target both the initial activating EGFR mutations and the T790M resistance mutation, while sparing wild-type, or normal EGFR at anticipated therapeutic doses, with an improved toxicity profile. Accordingly, it has the potential to be a first-line treatment in NSCLC patients with activating EGFR mutations and a second or later-line treatment in NSCLC patients who become resistant to EGFR-directed therapy due to the emergence of the T790M secondary mutation.
ganetespib
A synthetic small-molecule inhibitor of heat shock protein 90 (Hsp90) with potential antineoplastic activity. Ganetespib binds to and inhibits Hsp90, resulting in the proteasomal degradation of oncogenic client proteins, the inhibition of cell proliferation and the elevation of heat shock protein 72 (Hsp72); it may inhibit the activity of multiple kinases, such as c-Kit, EGFR, and Bcr-Abl, which as client proteins depend on functional HsP90 for maintenance. Hsp90, a 90 kDa molecular chaperone upregulated in a variety of tumor cells, plays a key role in the conformational maturation, stability and function of "client" proteins within the cell, many of which are involved in signal transduction, cell cycle regulation and apoptosis, including kinases, transcription factors and hormone receptors. Hsp72 exhibits anti-apoptotic functions; its up-regulation may be used as a surrogate marker for Hsp90 inhibition. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)
custirsen sodium 化疗药物
The eicosasodium salt of a mixed-backbone antisense oligodeoxynucleotide with chemosensitizing properties. Custirsen inhibits testosterone-repressed prostate message-2 (TRPM-2). Administration of custirsen abrogates the anti-apoptotic effect of TRPM-2, thereby sensitizing cells to chemotherapy and resulting in tumor cell death. TRPM-2 is an anti-apoptotic clusterin that is overexpressed by prostate cancer cells and is associated with chemoresistance. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus)
alectinib
An orally available inhibitor of the receptor tyrosine kinase anaplastic lymphoma kinase (ALK) with antineoplastic activity. Upon administration, alectinib binds to and inhibits ALK kinase, ALK fusion proteins as well as the gatekeeper mutation ALKL1196M known as one of the mechanisms of acquired resistance to small-molecule kinase inhibitors. The inhibition leads to disruption of ALK-mediated signaling and eventually inhibits tumor cell growth in ALK-overexpressing tumor cells. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development. ALK dysregulation and gene rearrangements are associated with a series of tumors. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus) 谢谢分享~呵呵 英文的看不懂，有中文就好了，但还是好消息 AP26113，想说爱你不容易！要多少米，才能拥有你！！！