A Seattle-based drugmaker saw its stock fall nearly 20 percent Monday morning as the Phase III registration study of its only approved product in non-Hodgkin’s lymphoma failed.
CTI BioPharma and its partner, France-based Servier, said Monday morning that the Phase III PIX306 study combining Pixuvri (pixantrone) with Roche’s Rituxan (rituximab) in diffuse large B-cell lymphoma, an aggressive NHL subtype, failed to show a statistically significant improvement in progression-free survival compared with Rituxan and the chemotherapy drug gemcitabine. CTI’s stock, which had been trading on NASDAQ at $5.20 per share when markets closed Friday, dropped to $4.30 in Monday morning trading.
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Pixuvri had received conditional approval in May 2012 from the European Medicines Agency for NHL on the basis of a prior Phase III study. A condition of the approval was that the company would have to successfully complete PIX306 as a confirmatory study.
In its 2013 annual report, CTI noted that while it was not pursuing US Food and Drug Administration approval for Pixuvri at the time, it would potentially reevaluate its FDA submission strategy for the drug after PIX306 data became available. The company had sought FDA approval for Pixuvri in 2009, but the agency issued a complete response letter. The company resubmitted its application, but withdrew it ahead of the April 2012 FDA action date because it required additional time to prepare the necessary information.
The company’s next most advanced product is pacritinib, a JAK inhibitor in Phase III development for the blood cancer myelofibrosis. However, pacritinib has had a rough history as well. The FDA placed a full clinical hold on pacritinib studies in February 2016 after reports that patients had died of brain hemorrhage, cardiac failure and cardiac arrests in the Phase III PERSIST-2 study, requiring all the patients on the study to discontinue pacritinib treatment and barring further enrollment. The hold was lifted in January 2017. Data from PERSIST-2 published in March 2018 showed that cardiac and bleeding events occurred at similar rates between patients receiving pacritinib and those in the comparator arm.
Last week, the company said the independent data monitoring committee for its Phase II PAC203 study of myelofibrosis patients who had previously received Incyte’s drug Jakafi – also a JAK inhibitor used for myelofibrosis – had recommended the study move forward without changes to the design following a review.
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