Seattle Genetics, Inc. (SGEN - Free Report) announced that it will discontinue the phase III study, CASCADE o vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. The company took this decision after consulting the Independent Data Monitoring Committee (IDMC) and after the review of data on Jun 16, 2017.
The data demonstrated higher number of deaths including fatal infections in vadastuximab talirine-containing arm versus control arm of trial. The company stated the safety concern in the trial did not appear related to hepatotoxicity. The company is discontinuing the patient enrollment and treatment in all of its vadastuximab talirine clinical trials. The company will closely review data and consult with FDA to determine future plans for vadastuximab talirine development program.
The shares of the company fell about 4% following the news. Seattle Genetics outperformed the Zacks classified Medical-Biomedical/Genetics industry year to date. The stock jumped almost 17.3% while the industry gained 6.4%.
Earlier in Dec 2016, the FDA had placed a partial clinical hold on two phase I trials to evaluate the potential risk of liver toxicity in patients treated with vadastuximab talirine of vadastuximab talirine in acute myeloid leukemia (AML). The clinical hold was initiated to evaluate a potential risk on patients who underwent a stem cell transplant either before or after the treatment. However, the FDA lifted the clinical hold in Mar 2017. The clinical hold on vadastuximab talirine was resolved through an analysis of the clinical data from over 300 patients treated to date and evaluated by an independent committee of clinical experts, collaborative interactions with the FDA and protocol amendments designed to further enhance patient safety.
The discontinuation of the trial is a key pipeline setback for the company. Consequently, the company will focus on other pipeline candidates. The company remains on track to release data from the Adcetris’ phase III ECHELON-1 trial in frontline Hodgkin lymphoma, and to advance enfortumab vedotin into a pivotal trial in metastatic urothelial cancer in the second half of 2017 under its collaboration with Astellas Pharma Inc. (ALPMY - Free Report) .
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank#3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. and MEI Pharma, Inc. (MEIP - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all four trailing quarters, with an average beat of 233.69%. The share price of the company has increased 0.9% year to date.
MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with average beat of 66.56%. The share price of the company has increased 43% year to date.
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