Lead company/partner	Compound	Indication	Comments
Phase III Results Published
Amgen Inc.	Parsabiv (etelcalcetide)	secondary hyperparathyroidism on dialysis	JAMA; Jan. 10, 2017 issue, three Phase III studies.
AB Science	masitinib	indolent systemic mastocytosis	The Lancet; Jan. 6 2017 online, Phase III study.
Advanced Accelerator Applications SA	Lutathera (177-lutetium labelled somatostatin analog)	neuroendocrine tumors	NEJM, Jan. 12, 2017; Phase III NETTER-1 study.
Keryx Biopharmaceuticals Inc.	Auryxia (ferric citrate)	iron deficiency anemia in chronic kidney disease	Journal of the American Society of Nephrology, Jan. 12, 2017, online.
Phase III Results
Coherus BioSciences Inc.	adalimumab biosimilar (CHS-1420)	psoriasis	PsOsim; updated results confirmed similarity to Humira.
Phase III Interim/Top-line Results
AbbVie Inc./Enanta Pharmaceuticals Inc.	glecaprevir plus pibrentasvir	hepatitis C	CERTAIN-1; 8 weeks of therapy shown to be safe and effective in Japanese patients.
Valeant Pharmaceuticals International Inc.	IDP-118 (halobetasol plus tazarotene)	psoriasis	302 Study; primary endpoint met in this second pivotal study.
Phase III Initiated
Nektar Therapeutics	NKTR-181	chronic pain	SUMMIT-HAL; pivotal study.
Amgen Inc.	Blincyto (blinatumomab)	diffuse large B-cell lymphoma	Phase II/III studies, alone or with Keytruda.
Roche	Tecentriq (atezolizumab)	castration-resistant prostate cancer	IMbassador250; with enzalutamide versus enzalutamide alone.
Phase III Announced
Eli Lilly & Co./Incyte Corp.	baricitinib	psoriatic arthritis	A JAK inhibitor, under review for rheumatoid arthritis.
Merck & Co. Inc./Incyte Corp.	epacadostat with pembrolizumab	non-small cell lung, renal, bladder, head and neck cancers	Combination Phase III studies expected to start in 2017.
Agios Pharmaceuticals Inc.	AG-348	pyruvate kinase (PK) deficiency	To start in 2018.
Phase II Suspended
Cempra Inc.	Solithera (solithromycin)	chronic obstructive pulmonary disease	Other indications continuing.
Phase II Results
Viamet Pharmaceuticals Holdings LLC	VT-1161, oral once-weekly doses	onychomycosis	RENOVATE; updated positive efficacy and well tolerated.
Rigel Pharmaceuticals Inc.	fostamatinib	immune thrombocytopenic purpura	Study 049; robust increases in platelet counts.
ValiRx PLC	VAL201	prostate cancer	Evidence of disease stabilization.
Phase II Interim/Top-line Results
BioMarin Pharmaceutical Inc.	BMN 270 gene therapy	hemophilia A	Proof-of-concept data released including normalisation of Factor VIII levels.
Rigel Pharmaceuticals Inc.	fostamatinib	IgA nephropathy	proteinuria improved, no safety issues.
TG Therapeutics Inc.	ublituximab, anti-CD20 Mab	multiple sclerosis	Profound B-cell depletion, well tolerated.
Debiopharm International SA	Debio 1450	skin and skin structure infections	Staph-selective, encouraging data.
Genprex	Oncoprex (TUSC2 gene therapy) plus erlotinib	NSCLC	positive interim data in late-stage patients.
The Medicines Co. /Alnylam Holding Co.	inclisiran (formerly PCSK9si)	dyslipidemia	ORION-1; durable LDL-C reductions, could be given two or three times yearly.
Shionogi & Co. Ltd. /GlaxoSmithKline PLC	cefiderocol (S-649266)	urinary tract infections	Met primary endpoint and well tolerated.
CureVac AG	CV9104, an RNA based vaccine	prostate cancer	Failed to improve overall survival or PFS.
Phase II Initiation
ThromboGenics NV	THR-317	diabetic macular edema	A PLGF neutralizing MAb.
arGEN-X NV	ARGX-113	myasthenia gravis	A proof-of-concept study.
Menlo Therapeutics Inc.	serlopitant	pruritus	ATOMIK, AUBURN; in atopic dermatitis or burn injury patients.
DS Biopharma	DS107, oral and topical	atopic dermatitis	In two separate trials.
The Medicines Co./Alnylam Holding Co.	inclisiran	homozygous familial hypercholesterolemia	ORION-2; and ORION-3, an open-label comparator study.
Ablynx NV	ALX-0171, inhaled	RSV infection	RESPIRE; in infants.
G1 Therapeutics Inc.	trilaciclib	triple negative breast cancer	An intravenous CDK4/6 inhibitor.
G1 Therapeutics Inc.	G1T38	estrogen receptor positive, HER2 negative breast cancer	An oral CDK4/6 inhibitor.
Myr GmbH/Heptera	Myrcludex B	hepatitis B and hepatitis D	In German and Russian patients.

Pipeline Watch: Phase III Trials In Prostate Cancer, Diffuse Large B-cell Lymphoma

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