FAILED TRIAL: Pivotal Phase 3 Study of Uproleselan in R/R AML patients did not meet its primary endpoint of OS in the intent to treat population

“While the outcome of our Phase 3 study in R/R AML is not what we hoped, we wish to thank the investigators, the participating patients and their families for their dedication to this large, well-controlled randomized study,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “We are thoroughly analyzing the data in collaboration with medical, statistical and regulatory experts and are committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting.”

Share:

More News

“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,

“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look

“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are