Ligufalimab合併阿扎胞苷和維奈克拉治療急性髓系白血病（AML）II期臨床試驗顯示總存活期獲益－臨床試驗先鋒

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The 9-month overall survival rate tells the most important story from Akeso’s phase II data: 78.7% of patients receiving ligufalimab plus azacitidine and venetoclax were alive at that mark, compared to 43.1% in the control arm, a gap that represents a meaningful separation for a population historically difficult to treat. The trial, AK117-206, is a randomized, double-blind, placebo-controlled study in treatment-naïve AML patients ineligible for intensive chemotherapy, and its results were presented as an oral session at EHA 2026 in June. The underlying backbone here matters. Azacitidine plus venetoclax received FDA approval for this exact population and has become the established standard of care, with the VIALE-A phase III trial reporting a median OS of 14.7 months. Ligufalimab is being layered onto that doublet, and the phase II data show that the triplet pushed median OS beyond 10 months of follow-up without being reached, versus 8.3 months in the control arm. Hazard ratios of 0.46 for both event-free survival and overall survival are striking at this stage, though the trial enrolled 60 patients per arm and phase II survival signals require phase III validation before any firm conclusions about magnitude. The response data add texture: an 80% ORR versus 66.7%, and MRD-negativity among complete responders at 46.7% versus 36.7%, with the median duration of composite complete response nearly doubling to 10.4 months from 5.6 months in controls. CD47 as a therapeutic target carries well-documented liability in AML; the “don’t eat me” signal it exploits is real but its blockade has generated anemia concerns across the class. In this dataset, anemia occurred in 46.7% of the ligufalimab arm versus 50.0% of controls, which suggests the antibody’s IgG4 backbone and its specific engineering are doing real work in managing that on-target toxicity. Ligufalimab received FDA Orphan Drug Designation for AML in September 2025, a regulatory marker that accelerates the path but does not substitute for a pivotal dataset. The one number worth tracking as Akeso moves toward a phase III decision is whether the OS hazard ratio of 0.46 holds its shape in a larger, more heterogeneous enrollment. Phase II HRs in AML frequently compress in confirmatory trials, and the degree of that compression will determine whether the triplet can displace the current standard or merely supplement it in a narrow molecular subgroup. Source link: https: //www. prnewswire. com/news-releases/ligufalimab-cd47-based-combination-achieves-deep-responses-and-survival-benefit-in-frontline-aml-phase-ii-results-presented-in-oral-session-at-eha-2026-302802782. html Milestone Pharmaceuticals to Present Etripamil Data at ACC FDA Approves Keytruda® Plus Pemetrexed and Platinum Chemotherapy for Malignant Pleural Mesothelioma eClinical Solutions and Snowflake Partner for Life Sciences Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends. Jon NapitupuluFDA Clears IND for EOM613 Trial in Cancer Cachexia Patients Jon NapitupuluZenas BioPharma Submits BLA for Obexelimab in IgG4-Related Disease Jon NapitupuluSenti Bio Advances SENTI-202 to Pivotal Trial With Donor X Selection Strategy Jon NapitupuluLifestyle Program Improves Brain Health in Cognitive Decline