Syndax Gains ASCO 2026 Podium for Revuforj Post-Transplant and PK Data Across Four Abstracts

Labeling teams and regulatory affairs leads tracking post-approval commitments for Revuforj® (revumenib) have new data to monitor: Syndax Pharmaceuticals will present four abstracts at the ASCO Annual Meeting (May 29–June 2, 2026, Chicago), including an oral presentation on post-transplant maintenance outcomes and a poster characterizing drug interaction and food-effect parameters with direct labeling implications.

The oral presentation, scheduled for Tuesday, June 2, covers safety and efficacy data from 21 adults and pediatric patients with KMT2A-rearranged, NPM1-mutated, or NUP98-rearranged acute leukemia who received revumenib as maintenance following hematopoietic stem cell transplantation (HSCT). Overall survival and relapse rates will be reported alongside a historical cohort comparison drawn from patients treated before revumenib's availability, providing a reference frame for clinical context rather than a controlled endpoint.

The pharmacokinetics poster carries the more immediate operational weight for QA and regulatory teams. The data address three specific parameters: co-administration with gastric acid reducing agents without efficacy attenuation, a defined dose adjustment strategy in the presence of strong CYP3A4 inhibitors, and administration with low-fat meals. For sites managing labeling updates or post-approval changes under 21 CFR Part 314, these findings could inform concomitant medication guidance and food-effect language in the current prescribing information. The CYP3A4 dose adjustment strategy, in particular, warrants close review against existing drug interaction sections ahead of any supplemental NDA activity.

Two additional abstracts detail the design of ongoing pivotal trials: the EVOLVE-2 phase 3 study pairing revumenib with venetoclax and azacitidine in newly diagnosed NPM1-mutated or KMT2A-rearranged AML patients ineligible for intensive chemotherapy, and a separate phase 3 study combining revumenib with intensive chemotherapy in newly diagnosed NPM1-mutated AML. Both are presented as trials-in-progress posters on Monday, June 1, and signal the validation dataset that will eventually underpin broader label expansion submissions.

Full abstracts are available on the ASCO conference website; presentation materials will be posted to the Syndax publications portal following each session.

The CYP3A4 interaction data and gastric acid reducing agent compatibility findings presented on June 1 represent the near-term checkpoint for regulatory teams assessing whether a labeling supplement is warranted before the pivotal trial readouts arrive.

Source: Syndax Pharmaceuticals via GlobeNewswire, May 21, 2026.