PhRMA Report 2012: Medicines in Development for Cancer

2012 Report
Medicines in Development

Cancer
presented by america’s biopharmaceutical
research companies

More Than 900 Medicines and Vaccines in
Clinical Testing Offer New Hope in the Fight
Against Cancer

Medicines in Development More Than
for Selected Cancer Types 1.6 million
New Cases
of Cancer
Are Expected
121
117 This Year
111

Few things cause more fear and apprehension approaches to fight cancer. They include:
94
than a cancer diagnosis. But today—because
• medicine that interferes with the me-
A
of early detection and a steady stream of new
tabolism of cancer cells by depriving them
and improved treatments—cancer increasingly
of the energy provided by glucose.
can be managed and even beaten. But patients
and their families are looking for more and bet- • medicine for acute myeloid leukemia
A
66 67
ter treatments, and America’s biopharmaceuti- (AML) that inhibits cancer cells with a
cal research companies are responding. mutation found in about a third of AML
sufferers.
Biopharmaceutical researchers are now work-
ing on 981 medicines for cancer. Many are • therapy that uses nanotechnology to
A
high-tech weapons to fight the disease, while target the delivery of medicines to cancer
some involve innovative research into using cells, potentially overcoming some limita-
existing medicines in new ways. tions of existing treatments.
Researchers’ deep commitment to patients and Despite recent progress, cancer remains the
advancing science is at the core of the remark- second leading cause of death by disease
able progress made in fighting cancer. In re- in the United States, exceeded only by heart
cent years we have seen significant declines in disease. In 2012, some 577,190 Americans are
cancer deaths. The number of cancer survivors expected to die of cancer—more than 1,500
living in the United States has increased from people a day. The hundreds of new medicines
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patients, their families and society.
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measure to earlier diagnosis and detection and
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better treatments and follow-up care.
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America’s biopharmaceutical research com-
panies are working on many new cutting-edge

Medicines in Development for Cancer

Medicines in Development for Cancer*

Bladder Cancer 9
Brain Cancer 62
Breast Cancer 111
Cervical Cancer 8
Colorectal Cancer 66
Head/Neck Cancer 25
Kidney Cancer 35
Leukemia 120
Liver Cancer 36
Lung Cancer 121
Lymphoma 117
Multiple Myeloma 57
Ovarian Cancer 63
Pancreatic Cancer 58
Prostate Cancer 94
Sarcoma 21
Skin Cancer 67
Solid Tumors 280
Stomach Cancer 23
Cancer-Related Conditions 38
Other Cancers 102
Unspecified Cancer 72

* Some medicines are listed in more than one category.

Bladder Cancer
Product Name Sponsor Indication Development Status*

Abraxane® Celgene second-line bladder cancer Phase II
albumin-bound paclitaxel Summit, NJ (see also breast, lung, ovarian, (908) 673-9000
pancreatic, skin)

AEZS-108 AEterna Zentaris (see also ovarian, prostate, other) Phase II
Basking Ridge, NJ (908) 626-5428

BC-819 BioCancell Therapeutics (see also ovarian, pancreatic) Phase II
(gene therapy) Jerusalem, Israel www.biocancell.com

EN3488 Endo Pharmaceuticals non-muscle invasive bladder cancer Phase III
(mycobacterium cell wall-DNA Chadds Ford, PA (Fast Track) (610) 558-9800
complex)

**For more information about a specific medicine in this report, please call the telephone number listed.

2 Medicines in Development Cancer 2012


Bladder Cance
Product Name Sponsor Indication Development Status

EOquin® Allergan non-invasive bladder cancer Phase III
apaziquone Irvine, CA (Fast Track) (949) 788-6700
Spectrum Pharmaceuticals
Irvine, CA

Folotyn® Allos Therapeutics (see also breast, lung, lymphoma) Phase II
pralatrexate Westminster, CO (303) 426-6262
(Orphan Drug)

icrucumab Eli Lilly (see also breast, colorectal) Phase II
(LY3012212/IMC-18F1) Indianapolis, IN (800) 545-5979
ImClone
Bridgewater, NJ

tesetaxel Genta second-line bladder cancer Phase II
Berkeley Heights, NJ (see also breast, prostate, skin, (908) 286-9800
stomach)

VB4-845 Viventia Biotechnologies (see also head/neck) Phase II
Mississauga, Canada (905) 362-2973

Brain Cancer

8H9 I-131 mAb United Therapeutics (see also sarcoma, other) Phase I
Silver Spring, MD (301) 608-9292

ABT-888 Abbott Laboratories (see also breast, colorectal, lung, Phase I
(veliparib) Abbott Park, IL lymphoma, ovarian, prostate, skin, (847) 937-6100
(PARP inhibitor) other)

AC480 Ambit Biosciences glioma Phase I
(pan-HER inhibitor) San Diego, CA (see also breast, lung) (858) 334-2100

AEE788 Novartis Pharmaceuticals glioblastoma Phase I/II
East Hanover, NJ (888) 669-6682

afatinib Boehringer Ingelheim glioblastoma Phase I/II
(BIBW2992) Pharmaceuticals (see also breast, head/neck, lung) (800) 243-0127
Ridgefield, CT

APN301 Apeiron Biologics neuroblastoma in children Phase II completed
(ch14.18 mAb/interleukin-2 Vienna, Austria (see also skin) www.apeiron-biologics.com
fusion protein)

Medicines in Development Cancer 2012 3


Brain Cancer

AR-67 Arno Therapeutics glioblastoma Phase II
Flemington, NJ (see also leukemia, solid tumors) (862) 703-7170

ARC-100 Archer Biosciences glioblastoma (recurrent) Phase II
New York, NY (see also breast, prostate, skin) (646) 747-9090
-------------------------------------------------- -------------------------------------------
neuroblastoma Phase I/II
(combination therapy) (646) 747-9090
-------------------------------------------------- -------------------------------------------
medulloblastoma Phase I
(combination therapy) (646) 747-9090

AT-101 Ascenta Therapeutics glioblastoma Phase II
(oral pan Bcl-2 inhibitor) Malvern, PA (see also leukemia, lung, lymphoma, (610) 408-0301
prostate, stomach)

Avastin® Genentech first-line glioblastoma multiforme Phase III
bevacizumab South San Francisco, CA (see also breast, colorectal, lung, (800) 626-3553
ovarian, other)

Azedra™ Molecular Insights Pharmaceuticals neuroblastoma (pediatric) Phase II
metaiodobenzylguanidine I-131 Cambridge, MA (Fast Track), paraganglioma, (617) 492-5554
(Orphan Drug) pheochromocytoma (Fast Track)

bafetinib CytRx second-line brain cancer Phase I
Los Angeles, CA (see also leukemia, prostate) (310) 826-5648

BKM120 Novartis Pharmaceuticals glioblastoma Phase I/II
(PI3K inhibitor) East Hanover, NJ (see also breast, lung, other) (888) 669-6682

ch14.18 mAb United Therapeutics neuroblastoma (children) Phase III
(Orphan Drug) Silver Spring, MD (301) 608-9292

cilengitide EMD Serono newly-diagnosed glioblastoma Phase III
(Orphan Drug) Rockland, MA (combination therapy) (800) 283-8088
(see also prostate)

cintredekin besudotox INSYS Therapeutics glioma (adolescents and children) Phase I
(Orphan Drug) Phoenix, AZ (Fast Track) (602) 910-2617

Cotara® Peregrine Pharmaceuticals recurrent glioblastoma Phase II
monoclonal antibody TNT-1 Tustin, CA (Fast Track) (714) 508-6000
(Orphan Drug)

CPP-1X Cancer Prevention Pharmaceuticals neuroblastoma Phase I
(eflornithine) Tucson, AZ (520) 908-7774



Brain Cancer

crenolanib AROG Pharmaceuticals glioma (adults) Phase II
(CP-868-596) Dallas, TX (see also stomach) (214) 594-0002
-------------------------------------------------- -------------------------------------------
glioma (pediatric) Phase I
(214) 594-0002

DCVax®-Brain Northwest Biotherapeutics glioblastoma Phase II
brain cancer vaccine Bethesda, MD (240) 497-9024
(Orphan Drug)

E7050 Eisai second-line glioblastoma Phase I/II
Woodcliff Lake, NJ (see also head/neck, liver, skin, (888) 422-4743
solid tumors, stomach)

E7080 Eisai glioma Phase II
(lenvatinib) Woodcliff Lake, NJ (see also skin, other) (888) 422-4743

EPO-806 Novartis Pharmaceuticals brain metastases from lung cancer Phase II
(patupilone) East Hanover, NJ (see also prostate) (888) 669-6682

G-100 prophage cancer vaccine Agenus newly-diagnosed glioma Phase II
(vitespen) Lexington, MA (781) 674-4400
(Orphan Drug)

G-200 prophage cancer vaccine Agenus recurrent glioma Phase II
(vitespen) Lexington, MA (781) 674-4400
(Orphan Drug)

GliAtak™ Advantagene glioma Phase II
gene therapy Auburndale, MA (617) 916-5445
(Orphan Drug) -------------------------------------------------- -------------------------------------------
brain cancer (children) Phase I
(617) 916-5445

GMB-Vax Activartis Biotech first-line glioblastoma Phase II
dendritic cell cancer vaccine Vienna, Austria www.activartis.com

GRN1005 Geron brain metastases Phase II
(LRP directed peptide-drug Menlo Park, CA (650) 473-7700
conjugate) -------------------------------------------------- -------------------------------------------
glioma Phase I completed
(650) 473-7700

GSK2118436 GlaxoSmithKline brain metastases from melanoma Phase II
(BRaf protein kinase inhibitor) Rsch. Triangle Park, NC (see also lung, skin) (888) 825-5249

Hycamtin® GlaxoSmithKline metastatic brain cancer Phase III
topotecan Rsch. Triangle Park, NC (888) 825-5249



Brain Cancer

ICT-107 ImmunoCellular Therapeutics glioblastoma Phase II
(dendritic cell vaccine) Woodland Hills, CA (818) 992-2907
(Orphan Drug)

Levulan® PDT DUSA Pharmaceuticals Phase II
aminolevulinic acid Wilmington, MA (978) 657-7500

lonafarnib Merck glioblastoma Phase I
Whitehouse Station, NJ (800) 672-6372

Lucanix® NovaRx glioma Phase I
belagenpumatucel-L San Diego, CA (see also lung) (858) 522-8600

macitentan Actelion Pharmaceuticals US glioblastoma (combination therapy) Phase I
South San Francisco, CA (650) 624-6900

MEDI-575 AstraZeneca glioblastoma Phase II
(anti-PDGFR-alpha mAb) Wilmington, DE (see also lung) (800) 236-9933
MedImmune (301) 398-0000
Gaithersburg, MD

mibefradil Tau Therapeutics glioblastoma Phase I
(T-type calcium channel Charlottesville, VA (434) 974-6969
inhibitor)
(Orphan Drug)

motexafin gadolinium Pharmacyclics glioblastoma (combination therapy) Phase II
Sunnyvale, CA (408) 774-0330

nimotuzumab YM Biosciences USA metastatic brain cancer, Phase II
(Orphan Drug) Lehigh Valley, PA recurrent glioma (pediatric) (610) 560-0600
(see also breast, prostate)

olaratumab Eli Lilly glioblastoma Phase II
(LY3012207) Indianapolis, IN (see also ovarian) (800) 545-5979
ImClone Systems
Bridgewater, NJ

Opaxio™ Cell Therapeutics glioma, glioblastoma Phase II
paclitaxel poliglumex Seattle, WA (see also lung, ovarian, stomach, (800) 215-2355
other)

perifosine AEterna Zentaris refractory metastatic glioma Phase II
Basking Ridge, NJ (see also colorectal, kidney, (908) 626-5428
leukemia, lung, lymphoma, multiple
myeloma, sarcoma, solid tumors,
stomach)



Brain Cancer

PLX3397 Plexxikon recurrent glioblastoma Phase II
(CSF-1R kinase inhibitor) Berkeley, CA (see also leukemia, lymphoma, (510) 647-4000
solid tumors)

Poly-ICLC Oncovir anaplastic astrocytoma (adolescents Phase II
(Orphan Drug) Washington, DC and children), glioblastoma www.oncovir.com
(adolescents and children)

PX-866 Oncothyreon second-line glioblastoma Phase II
Seattle, WA (see also head/neck, lung, prostate) (206) 801-2100

Reolysin® Oncolytics Biotech glioma Phase I/II
reovirus Calgary, Canada (see also colorectal, head/neck, lung, (403) 670-7377
ovarian, pancreatic, sarcoma,
skin, solid tumors)

rindopepimut Celldex Therapeutics first-line glioblastoma Phase III
(Orphan Drug) Needham, MA (Fast Track) (781) 433-0771
-------------------------------------------------- -------------------------------------------
second-line glioblastoma Phase II
(Fast Track) (781) 433-0771

SB-313-xTZ Sangamo Biosciences glioblastoma Phase I
Richmond, CA (510) 970-6000

SBG Biotec Pharmacon neuroblastoma (pediatric) Phase I/II completed
Tromsø, Norway www.biotec.no

SL-701 Stemline Therapeutics glioma (adults) Phase I/II
(brain cancer vaccine) New York, NY (212) 831-1111
-------------------------------------------------- -------------------------------------------
glioma (children) Phase I/II
(212) 831-1111

SPRYCEL® Bristol-Myers Squibb glioblastoma in clinical trials
dasatinib Princeton, NJ (see also breast, pancreatic, (800) 332-2056
prostate, other)

Tarceva® Genentech late-stage brain metastases, Phase II
erlotinib South San Francisco, CA recurrent ependymoma (children), (800) 626-3553
(Orphan Drug) OSI Pharmaceuticals glioblastoma (631) 962-0600
Farmingdale, NY (see also breast, head/neck,
leukemia, liver, lung, other)

terameprocol Erimos Pharmaceuticals glioma (intravenous) Phase I/II
Houston, TX (see also cervical, head/neck, (713) 541-2000
solid tumors, other)

TGF-ß R1 inhibitor Eli Lilly (see also liver) Phase II
(LY2157299) Indianapolis, IN (800) 545-5979



Brain Cancer

TH-302 Threshold Pharmaceuticals astrocytoma Phase II
South San Francisco, CA (see also leukemia, multiple (650) 474-8200
myeloma, pancreatic, sarcoma)

Toca 511/Toca FC Tocagen glioblastoma Phase I/II
(cytosine deaminase gene San Diego, CA (858) 412-8400
therapy)

trans-sodium crocetinate (TSC) Diffusion Pharmaceuticals gliobastoma Phase I/II
(Orphan Drug) Charlottesville, VA (434) 220-0718

TVI-Brain-1 TVAX Biomedical glioma Phase II
(cellular immunotherapy Lenexa, KS (913) 492-2221
vaccine)

VAL-083 Del Mar Pharmaceuticals grade IV malignant glioma Phase I/II
Vancouver, Canada (604) 629-5989

VB-111 VBL Therapeutics glioblastoma Phase I/II
Or Yehuda, Israel (see also other) www.vblrx.com

Xeloda® Genentech newly-diagnosed glioma Phase I
capecitabine South San Francisco, CA (adolescents and children) (800) 626-3553
(see also colorectal, liver, stomach)

Zelboraf® Genentech brain metastases Phase II
vemurafenib South San Francisco, CA (see also colorectal, other) (800) 626-3553
Plexxikon
Berkeley, CA

Breast Cancer

18F-fluorothymidine Merck breast cancer (diagnosis) Phase II

Abraxane® Celgene first-line metastatic breast cancer Phase II
albumin-bound paclitaxel Summit, NJ (see also bladder, lung, ovarian, (908) 673-9000
pancreatic, skin)

ABT-888 Abbott Laboratories (see also brain, colorectal, lung, Phase II

AC480 Ambit Biosciences (see also brain, lung) Phase I
(pan-HER inhibitor) San Diego, CA (858) 334-2100



Breast Cancer

acolbifene EndoCeutics Phase II
(4th-generation SERM) Quebec, Canada (418) 653-0033

AE37 peptide vaccine Antigen Express (see also ovarian) Phase II
Worcester, MA (508) 852-8783

afatinib Boehringer Ingelheim second-line metastatic breast cancer Phase III
(BIBW2992) Pharmaceuticals (see also brain, head/neck, lung) (800) 243-0127
Ridgefield, CT -------------------------------------------------- -------------------------------------------
first-line breast cancer Phase II
(800) 243-0127

afimoxifene ASCEND Therapeutics breast cancer (prevention) Phase II
Herndon, VA (703) 471-4744

Afinitor® Novartis Pharmaceuticals HER2-positive breast cancer Phase III
everolimus East Hanover, NJ (see also kidney, lymphoma) (888) 669-6682

AFP464 Kirax Phase II
Bonita Springs, FL (239) 444-5400

amrubicin Celgene late-stage breast cancer Phase I/II
Summit, NJ (see also lung) (908) 673-9000

ARC-100 Archer Biosciences (see also brain, prostate, skin) Phase II
New York, NY (646) 747-9090

ARRY-380 Array BioPharma Phase I
(HER2 inhibitor) Boulder, CO (877) 633-2436

AUY922 Novartis Pharmaceuticals breast cancer (monotherapy) Phase II
(Hsp90 inhibitor) East Hanover, NJ (see also colorectal, lung, multiple (888) 669-6682
myeloma, stomach)
-------------------------------------------------- -------------------------------------------
breast cancer (combination therapy) Phase I/II
(888) 669-6682



Breast Cancer

Avastin® Genentech adjuvant HER2-negative breast can- Phase III
bevacizumab South San Francisco, CA cer, adjuvant HER2-positive breast (800) 626-3553
cancer, adjuvant triple negative
breast cancer
(see also brain, colorectal, lung,
ovarian, other)

AZD8931 AstraZeneca advanced breast cancer Phase II
(erbB kinase inhibitor) Wilmington, DE (combination therapy) (800) 236-9933
(see also solid tumors)

BAY 86-5044 Bayer HealthCare Pharmaceuticals metastatic breast cancer Phase II completed
(lonaprisan) Wayne, NJ (888) 842-2937

BIIB 2024 Biogen Idec (see also stomach) Phase II completed
Cambridge, MA (617) 679-2000

BKM120 Novartis Pharmaceuticals second-line breast cancer Phase I/II
(PI3K inhibitor) East Hanover, NJ (see also brain, lung, other) (888) 669-6682

breast cancer vaccine Quantum Immunologics Phase I/II
(dendritic cell vaccine) Tampa, FL (866) 213-4594

brostallicin Cell Therapeutics triple-negative breast cancer Phase I
Seattle, WA (800) 215-2355

BTSCAN Molecular Targeting Technologies breast cancer (diagnosis) Phase I
West Chester, PA (610) 738-7938

BZL-101 Bionovo Phase I
Emeryville, CA (510) 601-2000

cabozantinib Exelixis (see also kidney, lung, ovarian, Phase II
(XL184) South San Francisco, CA prostate, other) (650) 837-7000

cancer vaccine MabVax Therapeutics (see also sarcoma) Phase I
San Diego, CA (858) 259-9405

CDX-011 Celldex Therapeutics breast cancer (Fast Track) Phase II
(glembatumumab vedotin) Needham, MA (see also skin) (781) 433-0771

CV-301 BN ImmunoTherapeutics metastatic breast cancer Phase II
(cancer vaccine) Mountain View, CA (650) 681-4660

D-1MT NewLink Genetics second-line metastatic breast cancer Phase I/II
Ames, IA (see also solid tumors) (515) 296-5555



Breast Cancer

dalotuzumab Merck second-line breast cancer Phase II
(MK-0646) Whitehouse Station, NJ (combination therapy) (800) 672-6372
(see also lung, pancreatic, other)
-------------------------------------------------- -------------------------------------------
first-line breast cancer Phase I
(800) 672-6372

DPX-0907 Immunovaccine (see also ovarian, prostate) Phase I
Halifax, Canada (902) 492-1819

eniluracil Adherex Technologies metastatic breast cancer Phase II
Rsch. Triangle Park, NC (combination therapy) (919) 636-4530

entinostat Syndax Pharmaceuticals (see also colorectal, kidney, Phase II
Waltham, MA leukemia, lung, lymphoma) (781) 419-1400

etirinotecan pegol Nektar Therapeutics metastatic breast cancer Phase III
(NKTR-102) San Francisco, CA (see also colorectal, ovarian, (855) 482-6587
solid tumors)

EZN-2208 Enzon Pharmaceuticals metastatic breast cancer Phase II
(PEG-SN38, firtecan pegol) Piscataway, NJ (see also colorectal, solid tumors) (973) 980-4500

Faslodex® AstraZeneca first-line advanced breast cancer Phase III
fulvestrant Wilmington, DE (800) 236-9933

folate binding protein (E39) Galena Biopharma (see also ovarian, other) Phase I
vaccine Lake Oswego, OR (855) 855-4253

Folotyn® Allos Therapeutics (see also bladder, lung, lymphoma) Phase II
pralatrexate Westminster, CO (303) 426-6262

ganetespib Synta Pharmaceuticals (see also colorectal, leukemia, liver, Phase II
(Hsp90i) Lexington, MA lung, multiple myeloma, pancreatic, (781) 274-8200
prostate, skin, stomach)

ganitumab Amgen combination therapy Phase II
(AMG 479) Thousand Oaks, CA (see also colorectal, lung, pancreatic, (800) 772-6436
sarcoma)

GDC-0980 Genentech hormone receptor-positive breast Phase II
(PI3 kinase/mTOR dual South San Francisco, CA cancer (800) 626-3553
inhibitor) (see also lymphoma, solid tumors)

GSK2302024A GlaxoSmithKline neoadjuvant breast cancer Phase I/II
(WT1 antigen-specific cancer Rsch. Triangle Park, NC (888) 825-5249
immunotherapeutic)

GVAX® Breast BioSante Pharmaceuticals Phase I
cancer vaccine Lincolnshire, IL (847) 478-0500



Breast Cancer

HER2 antigen-specific cancer GlaxoSmithKline Phase II
immunotherapeutic Rsch. Triangle Park, NC (888) 825-5249

icrucumab Eli Lilly metastatic breast cancer Phase II
(LY3012212/IMC-18F1) Indianapolis, IN (see also bladder, colorectal) (800) 545-5979
ImClone
Bridgewater, NJ

imetelstat Geron metastatic breast cancer Phase II
Menlo Park, CA (combination therapy) (650) 473-7700
(see also leukemia, lung,
multiple myeloma)

IMT-1012 immunotherapeutic Immunotope (see also ovarian) Phase I
vaccine Doylestown, PA (215) 253-4180

indibulin ZIOPHARM Oncology late-stage breast cancer Phase I/II
(ZIO-301) New York, NY (646) 214-0700

iniparib Sanofi US neoadjuvant breast cancer Phase II
(BSI-201) Bridgewater, NJ (see also lung, ovarian) (800) 981-2491

KW-2450 Kyowa Hakko Kirin Pharma first-line breast cancer, second-line Phase I/II
Princeton, NJ breast cancer (609) 919-1100

LFA102 Novartis Pharmaceuticals (see also prostate) Phase I
(anti-prolactin receptor anti- East Hanover, NJ (888) 669-6682
body) XOMA
Berkeley, CA

LGK974 Novartis Pharmaceuticals (see also skin) Phase I
(WNT signaling pathway East Hanover, NJ (888) 669-6682
inhibitor)

linifanib Abbott Laboratories breast cancer (combination therapy) Phase II
Abbott Park, IL (see also colorectal, kidney, liver, (847) 937-6100
lung)

liposome encapsulated Insys Therapeutics Phase II
paclitaxel (LEP-ETU) Phoenix, AZ (602) 910-2617

litronesib Eli Lilly metastatic breast cancer Phase II
(LY2523355) Indianapolis, IN (see also lung) (800) 545-5979

LOR-2040 Lorus Therapeutics metastatic breast cancer Phase II
Toronto, Canada (see also colorectal, kidney, (416) 798-1200
leukemia, prostate)

Lymphoseek® Navidea Pharmaceuticals breast cancer (diagnosis) application submitted
Tc-99m tilmanocept Dublin, OH (see also head/neck, skin) (614) 793-7500



Breast Cancer

maraciclatide GE Healthcare breast cancer (diagnosis) in clinical trials
Waukesha, WI www.gehealthcare.com

MK-0752 Merck early-stage breast cancer, Phase I
(notch signaling pathway Whitehouse Station, NJ late-stage breast cancer (800) 672-6372
inhibitor) (see also other)

MK-2206 Merck HER2-positive breast cancer Phase I
(c-akt inhibitor) Whitehouse Station, NJ (see also other) (800) 672-6372

MM-111 Merrimack Pharmaceuticals breast cancer (combination therapy) Phase I/II
Cambridge, MA (617) 441-1000

MM-302 Merrimack Pharmaceuticals Phase I
(anti-HER2 antibody Cambridge, MA (617) 441-1000
doxorubicin conjugate)

motesanib Amgen (see also colorectal, lung, other) Phase I/II
Thousand Oaks, CA (800) 772-6436

MVA-BN® HER2 BN ImmunoTherapeutics Phase I
(HER-2/neu-based MVA Mountain View, CA (650) 681-4660
vaccine)

Myocet™ Sopherion Therapeutics first-line breast cancer Phase III
doxorubicin liposomal Princeton, NJ (combination therapy) (Fast Track) (609) 986-2020

NeuVax™ Galena Biopharma early-stage breast cancer Phase III
cancer vaccine E75 Lake Oswego, OR (prevention of relapse) (855) 855-4253
(see also prostate)

Nexavar® Bayer HealthCare Pharmaceuticals (see also colorectal, head/neck, Phase III
sorafenib Wayne, NJ kidney, leukemia, liver, lung, multiple (888) 842-2937
myeloma, ovarian, other)

nimotuzumab YM Biosciences USA (see also brain, prostate) Phase I
Lehigh Valley, PA (610) 560-0600

NK-012 Nippon Kayaku (see also lung) Phase II
Tokyo, Japan www.nipponkayaku.co.jp

OBP-301 Oncolys Biopharma (see also head/neck, liver, lung) Phase I
Tokyo, Japan www.oncolys.com

OGX-427 OncoGenex Pharmaceuticals (see also lung, ovarian) Phase I
Bothell, WA (425) 686-1500



Breast Cancer

onartuzumab Genentech metastatic breast cancer Phase II
South San Francisco, CA (combination therapy) (800) 626-3553
(see also colorectal, lung)

OPT-822/OPT-821 Optimer Biotechnology Phase II/III
San Diego, CA (858) 909-0736

PB-272 (neratinib) Puma Biotechnology second-line breast cancer, Phase II
Los Angeles, CA neoadjuvant breast cancer (424) 248-6500

pertuzumab Genentech first-line metastatic breast cancer application submitted
-------------------------------------------------- -------------------------------------------
second-line late-stage breast cancer Phase II
(800) 626-3553

pertuzumab companion Dako breast cancer (diagnostic) Phase III
diagnostic Glostrup, Denmark www.dako.com
(HER2 FISH pharmDx™) Genentech (800) 626-3553
South San Francisco, CA

pertuzumab companion Dako breast cancer (diagnosis) Phase III
diagnostic Glostrup, Denmark www.dako.com
(HercepTest™) Genentech (800) 626-3553

pixantrone Cell Therapeutics breast cancer (Fast Track) Phase II
Seattle, WA (see also lymphoma) (800) 215-2355

PTC299 PTC Therapeutics (see also solid tumors, other) Phase I/II
South Plainfield, NJ (908) 222-7000

Quinamed® Cephalon (see also ovarian, prostate) Phase II
amonafide Frazer, PA (610) 344-0200

ramucirumab Eli Lilly metastatic breast cancer Phase III
(IMC-1121B) Indianapolis, IN (see also colorectal, stomach) (800) 545-5979
ImClone Systems
Bridgewater, NJ

Reximmune-C® Epeius Biotechnologies Phase I/II
personalized cancer vaccine San Marino, CA (626) 441-6695

Rexin-G® Epeius Biotechnologies metastatic breast cancer Phase I/II
San Marino, CA (see also pancreatic, sarcoma) (626) 441-6695



Breast Cancer

ridaforolimus ARIAD Pharmaceuticals metastatic breast cancer Phase II
Cambridge, MA (see also kidney, lung, prostate, (800) 672-6372
Merck sarcoma, other)
Whitehouse Station, NJ

rucaparib Clovis Oncology (see also ovarian) Phase II
Boulder, CO (303) 625-5000

sagopilone Bayer HealthCare Pharmaceuticals (see also ovarian, prostate) Phase II completed
Wayne, NJ (888) 842-2937

samarium SM-153 lexidronam EUSA Pharma (see also multiple myeloma, prostate, Phase II
injection Langhorne, PA sarcoma, other) (800) 833-3533

SAR245408 Sanofi US (see also other) Phase II
(XL147) Bridgewater, NJ (800) 981-2491
(oral PI3K inhibitor) Exelixis (650) 837-7000

SAR245409 Sanofi US (see also lymphoma) Phase II
(XL765) Bridgewater, NJ (800) 981-2491
(PI3K/mTOR inhibitor) Exelixis (650) 837-7000

SAR256212 Merrimack Pharmaceuticals (see also lung, ovarian) Phase II
(MM-121) Cambridge, MA (800) 981-2491
(anti-ErbB3 mAb) Sanofi US
Bridgewater, NJ

SF1 (sonodynamic therapy) SonneMed advanced breast cancer Phase I/II
Boston, MA www.sonnemed.com

SPRYCEL® Bristol-Myers Squibb (see also brain, pancreatic, prostate, in clinical trials
dasatinib Princeton, NJ other) (800) 332-2056

SR 16234 SRI International Phase II
Menlo Park, CA (650) 859-2000

Tarceva® Genentech (see also brain, head/neck, leukemia, Phase II
erlotinib South San Francisco, CA liver, lung, other) (800) 626-3553
OSI Pharmaceuticals (631) 962-0600
Farmingdale, NY

tesetaxel Genta first-line breast cancer Phase II
Berkeley Heights, NJ (see also bladder, prostate, skin, (908) 286-9800
stomach)



Breast Cancer

ThermoDox® Celsion recurrent breast cancer Phase I/II
doxorubicin liposomal Lawrenceville, NJ (see also colorectal, liver) (609) 896-9100

tigatuzumab Daiichi Sankyo (see also colorectal, liver, lymphoma, Phase II
(anti-DR5 antibody) Parsippany, NJ ovarian, pancreatic) (973) 944-2600

tivozanib Astellas Pharma US breast cancer (combination therapy) Phase I/II
(ASP4130/AV-951) Deerfield, IL (see also colorectal, kidney) (800) 695-4321
AVEO Pharmaceuticals (617) 299-5000
Cambridge, MA

TKI258 Novartis Pharmaceuticals metastatic breast cancer Phase II
(dovitinib) East Hanover, NJ (see also kidney, multiple myeloma, (888) 669-6682
prostate, skin, other)

trabectedin Johnson Johnson Pharmaceutical metastatic breast cancer Phase III
Research Development (see also ovarian, prostate, sarcoma) (800) 817-5286
Raritan, NJ

trastuzumab-DM1 Genentech Phase III
(RG3502) South San Francisco, CA (800) 626-3553

trastuzumab-DM1 Dako breast cancer (diagnosis) Phase III
companion diagnostic Glostrup, Denmark www.dako.com
(HercepTest™) Genentech (800) 626-3553

trastuzumab-DM1 Dako breast cancer (diagnosis) Phase III
companion diagnostic Glostrup, Denmark www.dako.com
(HER2 FISH pharmDx™) Genentech (800) 626-3553

TRC 105 TRACON Pharmaceuticals (see also ovarian, prostate, other) Phase I/II
(ENG protein inhibitor) San Diego, CA (858) 550-0780

trebananib Amgen (see also colorectal, kidney, liver, Phase II
(AMG386) Thousand Oaks, CA ovarian, stomach, other) (800) 772-6436

Tykerb® GlaxoSmithKline inflammatory breast cancer application submitted
lapatinib Rsch. Triangle Park, NC (see also colorectal, head/neck, (888) 825-5249
stomach)
-------------------------------------------------- -------------------------------------------
adjuvant breast cancer, first-line Phase III
metastatic breast cancer (888) 825-5249
-------------------------------------------------- -------------------------------------------
neoadjuvant breast cancer Phase II
(888) 825-5249

upamostat Wilex Phase II
(WX-671) Munich, Germany www.wilex.de



Breast Cancer

varlitinib ASLAN Pharmaceuticals Phase II
Singapore www.aslanpharma.com

VeriStrat® Biodesix advanced breast cancer Phase III
companion diagnostic test Boulder, CO (diagnosis-outcome test in (303) 417-0500
EGFR-TKI HER2-overexpressing tumors)

YM155 Astellas Pharma US (see also lymphoma) Phase II
(sepantronium) Deerfield, IL (800) 695-4321

Zolinza® Merck (see also leukemia, lung, lymphoma, Phase II
vorinostat Whitehouse Station, NJ multiple myeloma, other) (800) 672-6273

Zytiga® Janssen Biotech second-line metastatic breast cancer Phase II
abiraterone Horsham, PA (see also prostate) (800) 526-7736

Cervical Cancer

ADXS-HPV Advaxis cervical cancer, cervical Phase II
Princeton, NJ intraepithelial neoplasia (609) 452-9813

PM-00104 PharmaMar (see also sarcoma, other) Phase II
Madrid, Spain www.pharmamar.com

PV701 Wellstat Biologics (see also colorectal) Phase II
(replication-competent oncolytic Gaithersburg, MD (240) 683-2500
virus)

terameprocol Erimos Pharmaceuticals cervical intraepithelial neoplasia Phase II
Houston, TX (intravaginal) (713) 541-2000
(see also brain, head/neck, solid
tumors, other)

V503 Merck prevention of cervical cancer, Phase III
(HPV virus-like particle (VLP) Whitehouse Station, NJ prevention of vulvovaginal cancer (800) 672-6372
vaccine)

V505 Merck prevention of cervical cancer Phase II completed
(HPV vaccine) Whitehouse Station, NJ (800) 672-6372



Cervical Cancer

verpasep caltespen Akela Pharma cervical intraepithelial neoplasia Phase I completed
(cancer vaccine) Austin, TX (512) 834-0449

VGX-3100 Inovio Pharmaceuticals cervical intraepithelial neoplasia Phase II
(DNA cancer vaccine) Blue Bell, PA (877) 446-6846

Colorectal Cancer

ABT-888 Abbott Laboratories (see also brain, breast, lung, Phase II

Aptocine™ Light Sciences Oncology metastatic colorectal cancer Phase III
talaporfin Bellevue, WA (425) 957-8900

AUY922 Novartis Pharmaceuticals second-line colorectal cancer Phase I
(Hsp90 inhibitor) East Hanover, NJ (combination therapy) (888) 669-6682
(see also breast, lung, multiple
myeloma, stomach)

Avastin® Genentech metastatic colorectal cancer Phase III
bevacizumab South San Francisco, CA (treatment beyond progression) (800) 626-3553
(see also brain, breast, lung, ovarian,
other)

AVX701 AlphaVax colorectal cancer prevention in Phase I/II
(CEA cancer immunotherapy) Rsch. Triangle Park, NC patients with advanced or metastatic (919) 595-0400
CEA-expressing malignancies

belinostat Spectrum Pharmaceuticals colorectal cancer (combination Phase I/II
Henderson, NV therapy) (702) 835-6300
(see also leukemia, liver, lung,
lymphoma, ovarian, other)

brivanib Bristol-Myers Squibb metastatic colorectal cancer Phase II
(VEGFR/FGFR kinase inhibitor) Princeton, NJ (see also liver, sarcoma) (800) 332-2056

CPX-1 Celator Pharmaceuticals Phase II completed
(irinotecan/floxuridine) Princeton, NJ (609) 243-0123

CT-011 CureTech first-line metastatic colorectal cancer Phase II
Yavne, Israel (combination therapy) www.curetechbio.com
(see also leukemia, lymphoma)

E7820 Eisai Phase II
Woodcliff Lake, NJ (888) 422-4743



Colorectal Cancer

efatutazone Daiichi Sankyo metastatic colorectal cancer Phase II
Parsippany, NJ (see also lung, other) (973) 944-2600

EGEN-001 EGEN (see also ovarian, other) Phase I/II
Huntsville, AL (256) 512-0077

EGFR antagonist QIAGEN colorectal cancer (diagnosis) application submitted
companion diagnostic Valencia, CA www.qiagen.com

encapsulated cell therapy Rogosin Institute refractory metastatic colorectal Phase II
(macrobeads) New York, NY cancer (212) 746-1566
(see also pancreatic, prostate)

entinostat Syndax Pharmaceuticals metastatic colorectal cancer Phase II
Waltham, MA (combination therapy) (781) 419-1400
(see also breast, kidney, leukemia,
lung, lymphoma)

ERBITUX® Bristol-Myers Squibb first-line colorectal cancer in clinical trials
cetuximab Princeton, NJ (see also stomach) (800) 332-2056
Eli Lilly (800) 545-5979
Indianapolis, IN

etirinotecan pegol Nektar Therapeutics second-line colorectal cancer Phase II/III
(NKTR-102) San Francisco, CA (see also breast, ovarian, solid (855) 482-6587
tumors)

EZN-2208 Enzon Pharmaceuticals metastatic colorectal cancer Phase II
(PEG-SN38, firtecan pegol) Piscataway, NJ (see also breast, solid tumors) (973) 980-4500

FANG™ Vaccine Gradalis (see also ovarian, skin) Phase II
autologous tumor cell vaccine Carrollton, TX (214) 442-8100

ganetespib Synta Pharmaceuticals refractory, metastatic colorectal Phase II
(Hsp90i) Lexington, MA cancer (781) 274-8200
(see also breast, leukemia, liver,
lung, multiple myeloma, pancreatic,
prostate, skin, stomach)

ganitumab Amgen second-line metastatic colorectal Phase II
(AMG 479) Thousand Oaks, CA cancer (combination therapy) (800) 772-6436
(see also breast, lung, pancreatic,
sarcoma)

GI-4000 GlobeImmune (see also lung, pancreatic) Phase II
(cancer vaccine) Louisville, CO (303) 625-2700



Colorectal Cancer

GM-CT-01 Galectin Therapeutics colorectal cancer Phase II
Newton, MA (combination therapy) (617) 559-0033

GS-6624 Gilead Sciences (see also pancreatic) Phase II
(monoclonal antibody) Foster City, CA (800) 445-3235

GVAX® Colorectal BioSante Pharmaceuticals Phase I
cancer vaccine Lincolnshire, IL (847) 478-0500

icrucumab Eli Lilly (see also bladder, breast) Phase II
(LY3012212/IMC-18F1) Indianapolis, IN (800) 545-5979
ImClone
Bridgewater, NJ

IMO-2055 Idera Pharmaceuticals (see also head/neck, lung) Phase I
(TLR9 agonist) Cambridge, MA (617) 679-5000

Imprime PGG® Biothera (see also leukemia, lung, skin) Phase III
Eagan, MN (651) 675-0300

JX-594 Jennerex Biotherapeutics (see also liver) Phase I/II
(pexastimogene devacirepvec) San Francisco, CA (415) 281-8886

KRN-330 Kyowa Hakko Kirin Pharma colorectal cancer Phase I/II
Princeton, NJ (combination therapy) (609) 919-1100
-------------------------------------------------- -------------------------------------------
colorectal cancer (monotherapy) Phase I
(609) 919-1100

labetuzumab I-131 Immunomedics Phase II
(IMMU-111) Morris Plains, NJ (973) 605-8200

labetuzumab-SN-38 Immunomedics Phase I
(IMMU-130) Morris Plains, NJ (973) 605-8200

LGX818 Novartis Pharmaceuticals metastatic colorectal cancer Phase I
(RAF inhibitor) East Hanover, NJ (see also skin) (888) 669-6682

linifanib Abbott Laboratories second-line colorectal cancer Phase II
Abbott Park, IL (see also breast, kidney, liver, lung) (847) 937-6100

LOR-2040 Lorus Therapeutics metastatic colorectal cancer Phase II
Toronto, Canada (see also breast, kidney, leukemia, (416) 798-1200
prostate)

motesanib Amgen (see also breast, lung, other) Phase I
Thousand Oaks, CA (800) 772-6436



Colorectal Cancer

Nexavar® Bayer HealthCare Pharmaceuticals metastatic colorectal cancer Phase II
sorafenib Wayne, NJ (see also breast, head/neck, kidney, (888) 842-2937
leukemia, liver, lung, multiple

NPC-1C Neogenix Oncology metastatic colorectal cancer Phase I
(ensituximab) Rockville, MD (see also pancreatic) (301) 917-6893

onartuzumab Genentech (see also breast, lung) Phase II

OncoVAX® Vaccinogen (Fast Track) Phase I/II
active specific immunotherapy Frederick, MD (301) 668-8400

perifosine AEterna Zentaris refractory metastatic colorectal Phase III
Basking Ridge, NJ cancer (combination therapy) (908) 626-5428
(Fast Track)
(see also brain, kidney, leukemia,
lung, lymphoma, multiple myeloma,
sarcoma, solid tumors, stomach)

PHY906 PhytoCeutica (see also liver, pancreatic, Phase I/II
New Haven, CT cancer-related) (203) 777-3462

picoplatin Ponaird Pharmaceuticals (see also lung, ovarian, prostate) Phase II
Seattle, WA (206) 281-7001

polyclonal antibody stimulator Cancer Advances (see also pancreatic, stomach) Phase II
Durham, NC (919) 361-2162

PV701 Wellstat Biologics (see also cervical) Phase II
(replication-competent oncolytic Gaithersburg, MD (240) 683-2500
virus)

ramucirumab Eli Lilly (see also breast, stomach) Phase III
(IMC-1121B) Indianapolis, IN (800) 545-5979
ImClone
Bridgewater, NJ

regorafenib Bayer HealthCare Pharmaceuticals metastatic colorectal cancer Phase III
Wayne, NJ (Fast Track) (888) 842-2837
(see also kidney, lung, solid tumors,
stomach)

Reolysin® Oncolytics Biotech (see also brain, head/neck, lung, Phase I
reovirus Calgary, Canada ovarian, pancreatic, sarcoma, (403) 670-7377
skin, solid tumors)



Colorectal Cancer

RG7160 Roche second-line metastatic colorectal Phase II
(EGFR inhibitor) Nutley, NJ cancer (combination therapy) (973) 235-5000

RG7414 Genentech (see also lung) Phase II
(EGFL7 inhibitor) South San Francisco, CA (800) 626-3553

RIGScan™ Navidea Biopharmaceuticals metastatic colorectal cancer application submitted
tumor-specific, radio-labeled Dublin, OH (diagnosis) (800) 793-0079
monoclonal antibody targeting
agent

robatumumab Merck (see also sarcoma, solid tumors) Phase II completed

Sym004 Symphogen metastatic colorectal cancer Phase II
Lyngby, Denmark www.symphogen.com

TAS-102 Taiho Pharma U.S.A. Phase I
Princeton, NJ (609) 750-5300

telatinib ACT Biotech (see also stomach) Phase I
San Francisco, CA (415) 230-3900

TF2 Immunomedics colorectal cancer Phase I
(pretargeted radioimmuno- Morris Plains, NJ (973) 605-8200
therapy)

ThermoDox® Celsion adjuvant inoperable/unresectable, Phase II
doxorubicin liposomal Lawrenceville, NJ metastatic colorectal cancer (609) 896-9100
(see also breast, liver)

tigatuzumab Daiichi Sankyo (see also breast, liver, lymphoma, Phase I
(anti-DR5 antibody) Parsippany, NJ ovarian, pancreatic) (973) 944-2600

tivantinib ArQule (see also kidney, liver, lung, Phase I/II
(ARQ 197) Woburn, MA pancreatic, sarcoma, other) (781) 994-0300
Daiichi Sankyo (973) 944-2600
Parsippany, NJ

tivozanib Astellas Pharma US colorectal cancer Phase II
(ASP4130/AV-951) Deerfield, IL (combination therapy) (800) 695-4321
AVEO Pharmaceuticals (see also breast, kidney) (617) 299-5000
Cambridge, MA

trebananib Amgen (see also breast, kidney, liver, Phase II
(AMG386) Thousand Oaks, CA ovarian, stomach, other) (800) 772-6436

Tykerb® GlaxoSmithKline metastatic colorectal cancer Phase II
lapatinib Rsch. Triangle Park, NC (see also breast, head/neck, (888) 825-5249
stomach)



Colorectal Cancer

Vectibix® Amgen first-line and second-line colorectal application submitted
panitumumab Thousand Oaks, CA cancer (800) 772-6436
(see also head/neck)

Xeloda® Genentech first-line and second-line metastatic application submitted
capecitabine South San Francisco, CA colorectal cancer (800) 626-3553
(combination therapy)
(see also brain, liver, stomach)

Zaltrap™ Regeneron Pharmaceuticals second-line metastatic colorectal application submitted
aflibercept Tarrytown, NY cancer (914) 345-7400
Sanofi US (see also prostate) (800) 981-2491
Bridgewater, NJ

Zelboraf® Genentech (see also brain, other) Phase I
vemurafenib South San Francisco, CA (800) 626-3553
Plexxikon
Berkeley, CA

Head/Neck Cancer

ACE-041 Acceleron Pharma (see also multiple myeloma) Phase II
(dalantercept) Cambridge, MA (617) 649-9200

afatinib Boehringer Ingelheim second-line head/neck cancer Phase II
(BIBW2992) Pharmaceuticals (see also breast, brain, lung) (800) 243-0127
Ridgefield, CT

AP5346 Access Pharmaceuticals Phase II
Dallas, TX (214) 905-5100

E7050 Eisai (see also brain, liver, skin, solid Phase I/II
Woodcliff Lake, NJ tumors, stomach) (888) 422-4743

foretinib GlaxoSmithKline (see also kidney, liver, lung) Phase II completed
(GSK1363089) Rsch. Triangle Park, NC (888) 825-5249

GL-0810 Gliknik Phase I
(Orphan Drug) Baltimore, MD www.gliknik.com

GL-0817 Gliknik (see also multiple myeloma) Phase I
(Orphan Drug) Baltimore, MD www.gliknik.com

HF-10 Takara Bio Phase I
Shiga, Japan www.takara-bio.com



Head/Neck Cancer

IMO-2055 Idera Pharmaceuticals second-line head and neck cancer Phase II
(TLR9 agonist) Cambridge, MA (combination therapy) (617) 679-5000
(see also colorectal, lung)

IRX-2 IRX Therapeutics (Fast Track) Phase II
New York, NY (212) 582-1199

Lymphoseek® Navidea Pharmaceuticals head and neck cancer (diagnosis) Phase III
Tc-99m tilmanocept Dublin, OH (see also breast, skin) (614) 793-7500

Multikine® CEL-SCI first-line head and neck cancer Phase III
leukocyte interleukin Vienna, VA (703) 506-9460
(Orphan Drug)

Nexavar® Bayer HealthCare Pharmaceuticals (see also breast, colorectal, kidney, Phase II
sorafenib Wayne, NJ leukemia, liver, lung, multiple (888) 842-2937

OBP-301 Oncolys Biopharma (see also breast, liver, lung) Phase I
Tokyo, Japan www.oncolys.com

PX-866 Oncothyreon head and neck cancer (combination Phase II
Seattle, WA therapy) (206) 801-2100
(see also brain, lung, prostate)

Reolysin® Oncolytics Biotech metastatic head and neck cancer Phase III
reovirus Calgary, Canada (combination therapy) (403) 670-7377
(see also brain, colorectal, lung,
ovarian, pancreatic, sarcoma, skin,
solid tumors)

RG7597 Genentech Phase II
(EGFR antagonist) South San Francisco, CA (800) 626-3553

seliciclib Cyclacel Pharmaceuticals nasopharyngeal cancer Phase II
(CYC202) Berkeley Heights, NJ (see also solid tumors) (908) 517-7330

Tarceva® Genentech first-line head/neck cancer Phase II
erlotinib South San Francisco, CA (combination therapy) (800) 626-3553
OSI Pharmaceuticals (see also brain, breast, leukemia, (631) 962-0600
Farmingdale, NY liver, lung, other)

TAS-106 Taiho Pharma U.S.A. Phase II
Princeton, NJ (609) 750-5300


PhRMA Report 2012: Medicines in Development for Cancer

PhRMA Report 2012: Medicines in Development for Cancer

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PhRMA Report 2012: Medicines in Development for Cancer