1. Revumenib shows 77% ORR and 31% CR in leukemia patients. 2. Strong MRD negativity rates support Revumenib's effectiveness post-HSCT. 3. Phase 2 trial shows 86% ORR with Revumenib in combination therapy. 4. Revumenib combines well with chemotherapy, with 92% CRc in trials. 5. Investor event scheduled for December 8, 2025, to discuss new data.
FAQ
Why Very Bullish?
The reported clinical efficacy and positive trial results are strong indicators of market demand. Companies with innovative therapies that demonstrate high efficacy often see substantial stock price increases, as witnessed with breakthrough therapies in oncology.
How important is it?
With significant clinical results and investor engagement, the article reflects the company's potential to capture market share. The ongoing trials and positive responses indicate a strategic positioning in the oncology market.
Why Long Term?
The ongoing clinical trials and positive outcomes suggest sustained growth potential. Long-term investor sentiment will likely be bolstered as more data continues to emerge from Revumenib's studies.
Syndax Pharmaceuticals Unveils Promising Revuforj® Data at ASH 2025
Syndax Pharmaceuticals (Nasdaq: SNDX), a leading biopharmaceutical company focused on innovative cancer therapies, announced groundbreaking results for its FDA-approved menin inhibitor, Revuforj® (revumenib), at the 67th American Society of Hematology (ASH) Annual Meeting held in Orlando, Florida, from December 6 to 9, 2025. This announcement showcases pivotal findings across various acute leukemia treatment settings, particularly in patients with NPM1m, KMT2Ar, and NUP98r mutations.
Key Findings from Revuforj Presentations
- Real-World Efficacy: A retrospective analysis highlighted a 77% overall response rate (ORR) among patients receiving Revuforj.
- Complete Remission Rates: The study reported a 31% complete remission (CR) or complete remission with incomplete blood recovery (CRh) in the treated cohort.
- MRD Negativity: An impressive 75% of patients achieved measurable residual disease (MRD) negativity.
- Tolerability: Revuforj demonstrated favorable tolerability, particularly in combination with existing therapies.
Real-World Evidence from Retrospective Studies
A key retrospective review involved 17 patients treated with Revuforj in clinical practice settings. Notably:
- Patients’ median age was 54 years, with some aged between 23 and 79.
- 47% had KMT2Ar, 29% had NPM1m, and 18% had NUP98r mutations.
- The ORR was confirmed at 77% (10/13), with a promising 62% CRc and a 31% CR/CRh rate observed.
- A majority, 75% (9/12), of patients were MRD-negative by their best response.
Dr. David Sallman of Moffitt Cancer Center emphasized the significance of these findings, stating, “It is encouraging to observe the vast majority of patients achieve MRD negative responses... Our results underscore the potential for Revuforj to transform the standard of care for patients with menin-dependent acute leukemias.”
Promising Results from Pivotal Trials
Further results from ongoing clinical trials bolster the clinical potential of Revuforj:
- The Phase 2 SAVE trial evaluated Revuforj in combination with venetoclax and hypomethylating agents in newly diagnosed patients, yielding an ORR of 86% (18/21) and 100% MRD negativity among responders.
- A Phase 1 trial indicated robust activity with Revuforj in conjunction with intensive chemotherapy, achieving a remarkable 92% CRc.
Future Directions for Revuforj
Dr. Nick Botwood, Syndax’s Chief Medical Officer, remarked on the findings saying, “We are thrilled to share new data showing that Revuforj is highly efficacious with a favorable safety profile in multiple acute leukemia subtypes.”
With the commencement of pivotal frontline trials, Syndax aims to enhance the clinical data supporting Revuforj, positioning itself to lead in the acute leukemia treatment landscape.
Conclusion
The impressive results from Revuforj presentations at ASH 2025 mark a significant step forward for Syndax Pharmaceuticals (SNDX) and the treatment of acute leukemia. With its efficacy and safety data becoming increasingly validated, Revuforj stands to play a transformative role in the management of menin-dependent acute leukemias.