CTI BioPharma Corp. (CTIC - Free Report) and its privately-held partner Servier announced the failure of their pivotal phase III study evaluating cancer drug, Pixuvri, in combination with Roche (RHHBY - Free Report) and Biogen’s (BIIB - Free Report) Rituxan (rituximab) for the treatment of B-cell non-Hodgkin lymphoma (“NHL”).
CTI BioPharma’s shares fell almost 13.8% on Jul 9 following the disappointing news. However, shares of the company have rallied 67.2% so far this year, against the industry’s gain of 2.9%.
The pivotal PIX306 study compared Pixuvri and Rituxan combination regimen with the combination of chemo drug, gemcitabine, and Rituxan for the treatment of aggressive B-cell NHL, a form of blood cancer, in patients whose disease relapsed following CHOP-R chemotherapy. Data from the study showed that patients treated with Pixuvri regimen failed to achieve improvement in progression free survival compared to patients treated with gemcitabine regimen.
However, the company has plans to conduct a thorough review of the data from the study. CTI BioPharma expects to submit data from PIX306 study to the European Medicines Agency for review by the end of 2018.
Pixuvri has conditional approval in Europe as monotherapy for the treatment of multiply relapsed or refractory aggressive B-cell NHL. However, it is yet to receive approval in the United States.
There are approximately 168,000 newly diagnosed NHL patients every year in the United States and Europe. Several companies are developing drugs for the treatment for the disease. A few of them are developing the most advanced form of cancer treatment, CAR-T therapy, for treating NHL, which includes Celgene’s (CELG - Free Report) lisocabtagene.
The disappointing data from the PIX306 study negatively impacts Pixuvri’s prospects in an already competitive market.
CTI BioPharma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>