SSF-Based Sunesis Pharmaceuticals, Inc.'s Shares Crater After Failed Phase 3 Cancer Drug Study
Published: Oct 07, 2014
October 6, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Sunesis Pharmaceuticals, Inc. , the South San Francisco, Calif.-based biopharmaceutical company, today announced the results of its Phase 3 trial of Qinprezo (vosaroxin). The treatment that included vosaroxin failed to reach the study’s primary endpoint of a statistically significant improvement in overall survival for patients with an aggressive blood cancer known as acute myeloid leukemia (AML). In the wake of the announcement, the company’s share prices plunged 64% in pre-market trading, wiping out the 40% increase in share price the company had achieved thus far in 2014.
The study, named VALOR, was a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). VALOR involved 711 patients at 100 international locations.
Though the treatment failed to meet its primary endpoint, it did reach its secondary endpoint of a clinically significant benefit in the complete remission (CR) rate of AML in patients. Perhaps because of this result, Sunesis said in a press release that it would file for a marketing authorization application with the European Medicines Agency (EMA). In addition, the company will meet with the U.S. Food and Drug Administration (FDA) “to determine the appropriate regulatory path forward.”
“There remains an acute need for new treatment options in AML, particularly relapsed refractory patients, where no therapy has demonstrated a survival benefit in a pivotal Phase 3 trial in more than 40 years,” said Adam Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis in athe press release. “While we continue to evaluate the findings of VALOR in their totality, we believe the results demonstrate a clinically meaningful and important advancement in the treatment of this disease.”
Qinprezo (vosaroxin) is part of a class of compounds, called anti-cancer quinolone derivatives (AQD), that has not previously been used in the treatment of cancer. Both the FDA and the European Commission have granted vosaroxin orphan drug status, with the FDA additionally giving the drug fast track designation.
The Mayo Clinic defines AML as a cancer of the blood and bone marrow characterized by rapid progression. AML is the most common form of acute blood cancer in adults. , Sunesis stated in its press release that, “The American Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014.” The company also claimed that more than 50,000 people outside the US suffer from the disease, stating that, “It is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 50,000.”