Press release
United Therapeutics Announces Study of Unituxin® (dinutuximab) for Small Cell Lung Cancer Did Not Meet Primary Endpoint
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 3, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced topline
About this update from United Therapeutics Corporation
[{"type":"text","content":"SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Feb. 3, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced topline results from the phase 2/3 DISTINCT clinical study evaluating Unituxin® (dinutuximab) Injection added to irinotecan compared to irinotecan or topotecan alone in patients with relapsed or refractory small cell lung cancer (SCLC). The DISTINCT trial did not meet its primary efficacy objective of extending the overall survival with Unituxin and irinotecan versus using irinotecan alone. The safety profile of dinutuximab in DISTINCT was consistent with prior studies and the current Unituxin product label.\n\n \n \n\n \nFull data from the DISTINCT study will be made available through scientific disclosure at upcoming conferences and in peer-reviewed publications. \n\"We thank the principal investigators, patients and their families for participating in the DISTINCT study,\" said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. \"We're clearly disappointed with the DISTINCT results but we'll continue to seek out underappreciated avenues in our core therapeutic areas addressing rare diseases in oncology and pulmonary hypertension. In addition, we look forward to announcing the results of our INCREASE study by the end of the first quarter or shortly thereafter.\"\nUnited Therapeutics is also pursuing a label expansion for Unituxin in combination with irinotecan and temozolomide for the treatment of pediatric patients with relapsed or refractory neuroblastoma, based on results from the ANBL1221 study conducted by the Children's Oncology Group. United Therapeutics plans to meet with the FDA to discuss the proposed label expansion in the first half of 2020 and file a supplemental BLA shortly thereafter. \nAbout DISTINCT\nDISTINCT was a phase 2/3, two-part, open-label, randomized, international, multi-center study of dinutuximab and irinotecan versus irinotecan for second line treatment of patients with relapsed or refractory small cell lung cancer. The phase 2 portion of the study of 12 patients was completed in October 2017. Global enrollment in the phase 3 portion of the study was completed in October 2018 with a total of 471 patients. Patients were randomized 2:2:1 into three arms: irinotecan (190 patients); irinotecan and dinutuximab (187 patients); or topotecan (9...