Shares of CTI BioPharma Corp. are down more than 15 percent in premarket trading this morning after the company announced its combination treatment for B-cell non-Hodgkin lymphoma failed to meet endpoints in a late-stage trial.
Shares of Seattle-based CTI BioPharma Corp. are down more than 15 percent in premarket trading this morning after the company announced its combination treatment for B-cell non-Hodgkin lymphoma failed to meet endpoints in a late-stage trial.
CTI said its Phase III PIX306 trial evaluating Pixuvri (pixantrone) combined with Roche’s Rituxan (rituximab) failed to meet its primary endpoint of progression-free survival in comparison to a combination of gemcitabine and Rituxan. Pixuvri is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.
CTI’s Pixuvri has conditional marketing authorization from the European Commission as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The Phase III trial was being conducted as a post-authorization requirement of conditional marketing authorization. The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018, CTI said this morning. The company had been hoping for a positive result in order to support the approval of broader indications for Pixuvri by the European Medicines Agency.
CTI’s announcement was thin on details of the phase III failure. The company did not disclose how far off the mark its combination treatment was against the comparison medications. CTI said it intends to provide results from the study in an article published in a peer-reviewed journal.
Adam Craig, CTI BioPharma’s chief executive officer, said the company intends to conduct a thorough review of clinical data to assess the next steps for its Pixuvri program. He added that the company was disappointed with the trial outcome and expressed his gratitude to those who participated and ran the Phase III trial.
The Phase III PIX306 trial included 312 patients with aggressive B-cell non-Hodgkin lymphoma who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint of the trial was progression-free survival, while overall survival, complete response rate, overall response rate (ORR) and safety were secondary endpoints. There was no indication from the company how the combination treatment fared with the secondary endpoints.
There are approximately 168,000 new cases of NHL diagnosed in the United States and Europe every year. NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.
CTI’s stock closed at $5.20 per share on Friday. In premarket trading, shares had fallen to $4.40.
