Company

Product

Description

Indication

Status

Date

Phase I

Immutep Ltd., of Sydney

Eftilagimod alpha

LAG-3Ig fusion protein

Unresectable or metastatic melanoma

Drug plus Keytruda produced an overall response rate of 61% in 18 patients, including 2 complete responses

5/30/18

Phase II

Daiichi Sankyo Co. Ltd., of Tokyo

DS-8201

HER2-targeting antibody-drug conjugate

Unresectable and/or metastatic nonsquamous HER2-overexpressing or HER2-mutated non-small-cell lung cancer that has progressed after one or more prior therapies

Treated the first of approximately 80 patients, testing objective response rate as the primary endpoint

5/31/18

Phase III

Kyowa Hakko Kirin Co. Ltd., of Tokyo

Bardoxolone methyl

Activator of Nrf2

Diabetic kidney disease

Initiated multicenter, randomized, double-blind, placebo-controlled trial enrolling an estimated 700 diabetic kidney disease patients with CKD stage G3 or G4; primary efficacy endpoint is time to onset of a ≥ 30% decrease in estimated glomerular filtration rate from baseline or end-stage renal disease

6/4/18

Shenzhen Chipscreen Biosciences Co. Ltd., of Shenzhen, China

Epidaza

Subtype-selective HDAC inhibitor

Hormone receptor-positive, HER2-negative advanced breast cancer after failure of tamoxifen and/or a nonsteroidal aromatase inhibitor

Epidaza plus exemestane reached primary endpoint of progression-free survival; further details weren't disclosed

5/29/18

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan

Entyvio (vedolizumab)

Alpha4beta7 integrin antagonist

Ulcerative colitis and Crohn's disease

Real-world data showed numerically lower rates of serious infections [6.9% vs. 10.1%; odds ratio (OR) 0.67, 95% confidence interval (CI) 0.41-1.07] and significantly lower rates of serious adverse events [7.1% vs. 13.1%; OR 0.51, 95% CI 0.32-0.81] in patients treated with Entyvio (n=436) compared to TNF alpha-antagonist therapy (n=436)

6/4/18


Notes

The date indicated refers to the BioWorld Clinical data table in which the news item can be found.

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