4SC AG, of Planegg-Martinsried, Germany, said Japanese partner Yakult Honsha Co. Ltd., of Tokyo, reported that the phase II portion of the phase I/II trial testing 4SC’s epigenetic cancer compound resminostat in combination with Nexavar (sorafenib, Amgen Inc. and Bayer AG) as a first-line treatment in Asian patients with hepatocellular carcinoma (HCC) did not meet the primary endpoint of statistically significantly prolonged time to disease progression (TTP). Based on the results from that 170-patient study, Yakult will not conduct a pivotal trial in HCC in all-comer patients. However, it noted that patients with high expression levels of the ZFP64 biomarker at baseline seemed to have longer TTP in the combination regimen vs. Nexavar monotherapy. Yakult is analyzing the data in more detail. The firms inked the deal for resminostat in Japan in 2011 and launched the Japanese phase II trial in HCC in 2014. (See BioWorld Today, May 9, 2014.)
Astrazeneca plc, of London, reported results from the phase III FALCON trial comparing fulvestrant 500 mg to anastrozole 1 mg for the treatment of locally advanced or metastatic breast cancer in postmenopausal women who have not had prior hormonal treatment for hormone receptor-positive disease. Fulvestrant demonstrated superiority and met its primary endpoint of extended progression-free-survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines. Fulvestrant, an estrogen receptor antagonist, is approved as Faslodex for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer whose disease has progressed following anti-estrogen therapy.
Aviragen Therapeutics Inc., of Atlanta, formerly Biota Pharmaceuticals, said it voluntarily decided to delay further enrollment in the phase II study of antiviral candidate BTA585 for the treatment of respiratory syncytial virus infections being conducted in the U.K., following a lab report from one subject showing an increase of a cardiac enzyme level coupled with transient ECG changes, which led to a hospitalization of less than 24 hours. The subject’s ECGs were normal prior to hospitalization and the cardiac enzyme levels returned to baseline shortly thereafter. The company also reported that it received verbal communication from the FDA that the investigational new drug application for BTA585 was placed on clinical hold.
Genentech Inc., of South San Francisco, a unit of the Roche Group, reported results from the pivotal phase III GALLIUM study in patients with previously untreated follicular lymphoma, showing that those receiving Gazyva (obinutuzumab) plus chemotherapy followed by Gazyva alone had significantly improved progression-free survival vs. those receiving Rituxan (rituximab) plus chemotherapy followed by Rituxan alone. Adverse events with either Gazyva, a monoclonal antibody designed to attach to CD20, or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies.
Sage Therapeutics Inc., of Cambridge, Mass., said it completed enrollment in a phase II placebo-controlled study testing SAGE-547 in women with severe postpartum depression. The company decided to include 30-day follow-up data in its top-line announcement, with those results expected in July. The study is designed to enroll up to 32 patients, with a primary endpoint measured using the Hamilton Rating Scale for Depression score from baseline to 60 hours. SAGE-547, which targets GABA receptors, is in phase III testing in super-refractory status epilepticus. (See BioWorld Today, June 10, 2015.)
The Medicines Co., of Parsippany, N.J., said it completed patient enrollment in the phase III TANGO 1 study testing Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections. The study, initiated in late 2014 under a cost-share agreement with the Biomedical Advanced Research and Development Authority, is randomizing about 550 patients to either Carbavance, which combines a carbapenem with a beta-lactamase inhibitor, or piperacillin/tazobactam each given intravenously for up to 10 days. Top-line data are expected in the second half of this year.