Seattle Genetics Starts Trial On Acute Myeloid Leukemia Drug

Seattle Genetics, Inc. (NASDAQ:SGEN) announced that it has initiated a phase III trial, CASCADE, on vadastuximab talirine (SGN-CD33A).

The randomized, double-blind, placebo-controlled trial will evaluate if vadastuximab talirine, in combination with Vidaza or Dacogen, can extend overall survival compared to Vidaza or Dacogen alone in older patients with newly diagnosed acute myeloid leukemia (AML).

We note that Vidaza and Dacogen are hypomethylating agents (HMAs) that are commonly used for the treatment of older AML patients.

According to the American Cancer Society, AML will affect 20,000 people in the U.S. in 2016, and result in 10,500 deaths. Hence, there is significant need for treatments in this area.

The trial will enroll 500 patients globally who will be randomized on a 1:1 ratio to be treated with an HMA plus 33A or an HMA plus placebo.

Interim results from the ongoing phase I study, evaluating 33A in combination with HMAs in frontline AML and as monotherapy in primarily relapsed AML, were presented in 2015. Data from the phase I 33A combination trial showed that 15 out of 23 (65%) evaluable patients achieved complete remission and complete remission with incomplete hematologic recovery (CR/Cri). Updated data from the ongoing phase I study on 33A in combination with HMAs will be presented in an oral presentation at the 2016 European Hematology Association Congress scheduled next month.

Meanwhile, Seattle Genetics is evaluating 33A across multiple lines of therapy in patients with AML and myelodysplastic syndromes (MDS) in various trials.

We note that Adcetris is the only marketed product in Seattle Genetics’ portfolio, which has made the company highly dependent on the drug for growth. As a result, the development of pipeline candidates is essential for the company to reduce its dependence on Adectris. Successful development and commercialization of vadastuximab talirine will boost Seattle Genetics’ top line significantly.

Seattle Genetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories (NYSE:ABT) , Johnson & Johnson (NYSE:JNJ) and Sanofi (NYSE:SNY) . All three stocks carry a Zacks Rank #2 (Buy).