Core Insights - Syndax Pharmaceuticals has advanced revumenib into the Phase 1b portion of its Phase 1/2 trial for relapsed or refractory metastatic microsatellite stable colorectal cancer, supported by favorable initial data from the Phase 1a trial [1][2][6] Group 1: Trial Details - The Phase 1/2 trial (NCT05731947) aims to evaluate the safety, tolerability, and anti-tumor activity of revumenib in patients with relapsed or refractory metastatic MSS CRC [2] - The Phase 1a portion enrolled 19 patients with a median of four prior therapies, testing three dose levels: 163 mg, 226 mg, and 276 mg three times a day [2] - Revumenib demonstrated a favorable safety profile with no Grade 3 or greater treatment-related adverse events, and common adverse events included decreased appetite, dysgeusia, nausea, and fatigue [2][6] Group 2: Efficacy Results - Initial efficacy results indicated that at doses believed to achieve full target saturation, 44% of patients had stable disease at 8 weeks, and 33% had stable disease at 16 weeks [2] - One patient experienced prolonged stable disease for 32 weeks, supporting the advancement to Phase 1b with a selected dose of 276 mg TID [2][6] Group 3: Company Overview - Syndax Pharmaceuticals is focused on developing innovative cancer therapies, including revumenib and axatilimab, a monoclonal antibody targeting the CSF-1 receptor [4] - The company is preparing for potential product launches later in the year, emphasizing the role of revumenib in treating R/R metastatic MSS CRC [6] Group 4: Industry Context - Metastatic microsatellite stable colorectal cancer is the second leading cause of cancer death in the U.S., with over 55,000 patients estimated in the relapsed or refractory setting annually [7] - The Wnt/β-catenin signaling pathway is a key driver in CRC tumors, and menin inhibition has shown promise in blocking tumor growth in preclinical models [7]
Syndax Announces Plans to Advance into Phase 1b Portion of Trial Evaluating Revumenib in Relapsed or Refractory Metastatic MSS CRC