On November 4, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, reported the Company will be presenting early clinical data from ASPEN-02, its ongoing Phase 1/2 study evaluating evorpacept in combination with azacitidine for the treatment of myelodysplastic syndromes ("MDS") in a poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting held December 11-14, 2021 in Atlanta, Georgia (Press release, ALX Oncology, NOV 4, 2021, View Source [SID1234594363]).
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Key Abstract Data
As of July 15, 2021, 13 subjects with newly diagnosed ("ND") higher risk or relapsed/refractory ("R/R") MDS were enrolled into phase 1 cohorts receiving escalating doses of evorpacept (20 mg/kg Q2W, 30 mg/kg Q2W, and 60 mg/kg Q4W) combined with standard doses of azacitidine. Of the 7 ND subjects, 4 had therapy-related MDS, and 5 had TP53 mutation with complex cytogenetics. Of the 6 R/R subjects, all had received at least one hypomethylating agent-based regimen.
Among the 5 ND subjects evaluable for response (all with TP53 mutation), there were 2 subjects with cytogenetic response who met criteria for complete response ("CR") subsequent to the date of this abstract, 1 subject with a best response of marrow complete response ("mCR") with hematologic improvement ("HI"), and 1 subject each with stable disease ("SD") and progressive disease ("PD"). Of the 4 ND subjects who were transfusion dependent at baseline, 2 achieved transfusion independence. Among the 5 R/R subjects evaluable for response, there were 2 subjects with a best response of mCR, 2 with SD, and 1 with PD. No dose-limiting toxicities were observed in any cohort and no maximum tolerated dose was reached. Additional results will be presented at the conference.
Poster Presentation Details
Title: Evorpacept (ALX148), a CD47-Blocking Myeloid Checkpoint Inhibitor, in Combination with Azacitidine: A Phase 1/2 Study in Patients with Myelodysplastic Syndrome (ASPEN-02)
Session Name: 637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster II
Presentation Date and Location: December 12, 2021, 6:00pm – 8:00pm ET, Georgia World Congress Center, Hall B5
Publication Number: 2601