Program: Oral and Poster Abstracts
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeted and Immune-based Approaches in the Treatment of AML
Eligible patients were between 18-70 years of age with AML and either a) primary refractory disease following ≤ 2 cycles of induction chemotherapy, b) first relapse with no prior unsuccessful salvage chemotherapy, or c) relapsed or refractory to hypomethylating agents. Selinexor 60 mg/d was administered on days 1, 5, 10, and 12 in combination with CLAG, (cladribine 5 mg/m2/d on d4-8, cytarabine 2000 mg/m2/d on d4-8 and G-CSF 300 mcg/d on d3-8). The primary endpoint was rate of complete remission (CR + CRi) for selinexor + CLAG per 2003 IWG criteria.
Thirty patients with a median age of 56 years (range 21-70) have been enrolled in the study of which 19 (63%) were treated in first relapse, 10 (33%) failed induction chemotherapy and 1 (3%) was refractory to hypomethylating agent. The complete remission rate for 28 evaluable patients was 50%, (7 CR, 7 CRi). Median time to neutrophil recovery (ANC >1,000/mm3) following treatment was 28 days (range 21-52). Toxicity data is available for the first 27 patients. The most common nonhematologic treatment emergent adverse events included weight loss (n=17, 63%) nausea (16, 59%), mucositis (16, 59%), elevations in AST (15, 56%), ALT (13, 48%), alk phos (13, 48%), and fatigue (13, 48%), the majority of which were G1-2. Serious adverse events occurred in 14 patients, the most frequently due to sepsis (n=6, 22%). Early death within 30 days of the start of treatment occurred only in 1 subject (4%) due to respiratory failure. Of the initial 25 patients treated, 15 have undergone subsequent allogeneic hematopoietic cell transplantation (60%). We conclude that selinexor + CLAG is highly active in patients with relapsed or refractory AML and has encouraging rates of CR. Furthermore, the combination serves as a bridge which allows a high percentage of patients to undergo allogeneic hematopoietic cell transplantation.
Disclosures: Uy: Boehringer Ingelheim: Consultancy; GlycoMimetics: Consultancy; Novartis: Consultancy, Other: Travel Suppport. Riedell: Kite Pharma: Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees; Bayer: Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees. Romee: Altor BioScience LLC: Research Funding. Vij: Amgen: Honoraria, Research Funding; Jazz: Honoraria; Konypharma: Honoraria; Takeda: Honoraria, Research Funding; Bristol-Meyers-Squibb: Honoraria; Janssen: Honoraria; Celgene: Honoraria; Abbvie: Honoraria.
See more of: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation
See more of: Oral and Poster Abstracts