Announcement • May 24
Syndax Pharmaceuticals Announces Four Revuforj Abstracts Accepted for Asco 2026
Syndax Pharmaceuticals announced the acceptance of four Revuforj (revumenib) abstracts for presentation at the American Society of Clinical Oncology Annual Meeting, taking place May 29 – June 2, 2026, in Chicago. An oral presentation will highlight favorable outcomes observed among 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib post-transplant. Data underscoring unique aspects of revumenib’s PK profile, including the ability to administer it with gastric acid reducing agents and low-fat meals, will be presented. Design of ongoing pivotal trials of revumenib plus low or high-intensity chemotherapy in newly diagnosed NPM1m or KMT2Ar acute leukemia will be highlighted. Key revumenib presentations at ASCO 2026: An oral presentation of safety and efficacy data from 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib as maintenance following hematopoietic stem cell transplantation (HSCT). The presentation will include the observed overall survival and relapse rate, along with a comparison to a historical cohort of patients with the same genetic subtypes of acute leukemia treated prior to the advent of revumenib. A poster presentation characterizing the pharmacokinetics (PK) of revumenib, with an emphasis on differentiating aspects of its PK profile, including the ability to 1) administer revumenib with gastric acid reducing agents without the risk of reduced efficacy, 2) ensure optimal exposure in the presence of strong CYP3A4 inhibitors using a clear revumenib dose adjustment strategy, and 3) administer revumenib with low-fat meals. The accepted abstracts listed below are now available online on the ASCO conference website. Copies of the oral and poster presentations will be made available in the ‘Publications & Meeting Presentations’ section of the Syndax website after the data are presented. Full list of revumenib abstracts accepted for presentation at ASCO 2026 (all times in CDT): Revumenib as maintenance for AML following allogeneic stem cell transplantation Abstract number: 6505 Oral presentation Tuesday, June 2, 9:45 am-12:45 pm Pharmacokinetic (PK) assessment of revumenib in patients with relapsed/refractory (R/R) acute leukemias harboring a KMT2A rearrangement (KMT2Ar) or NPM1 mutation (NPM1m): Impact of food and concomitant medications Abstract number: 6528 Poster presentation Monday, June 1, 9:00 am – 12:00 pm A phase 3 study of revumenib plus venetoclax/azacitidine in adults with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia ineligible for intensive chemotherapy (EVOLVE-2/HO177/AMLSG35-24/ACT-HOV-AML-002): Trial in progress Abstract number: TPS6600 Poster presentation Monday, June 1, 9:00 am – 12:00 pm A phase 3 study of revumenib in combination with intensive chemotherapy in patients with newly diagnosed NPM1-mutated acute myeloid leukemia (REVEAL-ND NPM1): Trial in progress Abstract number: TPS6602 Poster presentation Monday, June 1, 9:00 am – 12:00 pm Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also indicated for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with NPM1m or KMT2Ar AML. WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with Revuforj. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. QTc prolongation and Torsades de Pointes have occurred in patients receiving Revuforj. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate Revuforj in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue Revuforj. Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension. In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%. Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids. QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes. Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation.
