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ALX Oncology Announces Initial Data from ASPEN-02, the Ongoing Phase 1 / 2 Study of Evorpacept in Combination with Azacitidine, Demonstrating Safety and Preliminary Activity in Patients with Myelodysplastic Syndrome
-- Complete remissions with cytogenetic responses, hematologic improvement, and transfusion independence were observed in patients with previously untreated
About this update from Alx Oncology Holdings Inc.
[{"type":"text","content":"-- Complete remissions with cytogenetic responses, hematologic improvement, and transfusion independence were observed in patients with previously untreated higher-risk MDS -- Objective responses were observed in patients with relapsed/refractory MDS that had progressed after prior hypomethylating agents -- No exacerbation of cytopenias and no dose limiting toxicities observed in combination with azacitidine -- ALX Oncology to Host Conference Call on December 13th at 8:00 a.m. EST SOUTH SAN FRANCISCO, Calif., Dec. 12, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced the presentation of initial clinical data from its ongoing trial evaluating evorpacept in combination with azacitidine for the treatment of patients with previously untreated higher-risk (“HR”) or relapsed or refractory (“r/r”) myelodysplastic syndrome (“MDS”). The new results, shared in a poster at the 63rd American Society of Hematology (“ASH”) Annual Meeting [Abstract #2601], show that the combination of evorpacept and azacitidine is active and well tolerated. As of October 25, 2021, 22 patients with either previously untreated HR or r/r MDS have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks (“Q2W”) or 60 mg/kg once every 4 weeks (“Q4W”) together with standard dosing of azacitidine. Median follow-up is 3.4 months, and accrual is ongoing. Evorpacept in combination with azacitidine was well tolerated (N=22) with no dose limiting toxicities, no observed treatment related serious adverse events, and a maximum administered dose of 60 mg/kg Q4W. In 6 previously untreated HR MDS response-evaluable patients, 3 patients achieved an objective response (“OR”) (2 complete response (“CR”), 1 marrow CR), and 2 patients achieved stable disease (“SD”). Two out of 4 transfusion dependent patients achieved transfusion independence on study. Among 5 previously untreated HR MDS patients with TP53 mutation and complex cytogenetic abnormalities, 3 achieved an OR (2 CR and 1 marrow CR). Five of 9 patients with response-evaluable relapsed or refractory MDS that had progressed upon prior hypomethylating agents achieved an OR (5 marrow CRs). In additio...