Preliminary clinical results of ESMO field direct-attack anti-CD47 monoclonal antibody Lemzoparlimab combined with azacytidine in the treatment of newly diagnosed patients with HR-MDS

The 2022 Annual Meeting of the European Society of Oncology (ESMO) was held

Research methodology

Untreated patients with IPSS-R medium- or high-risk MDS receive 30 mg/kg of Lemzoparlimab (intravenously) per week, and AZA (subcutaneously; 28 days for a cycle).

Research results

As of March 31, 2022, 53 patients were enrolled, and the baseline characteristics of patients are shown in Figure 1

Figure 1

Among the 29 patients with assessable efficacy ≥ 4 months of initial treatment, the overall response rate (ORR) was 86.

Figure 2

Over time, most patients have significantly improved levels of haemoglobin (HgB) and platelets (PLT), accompanied by a decrease in

In terms of safety (Figure 3), the most common grade of any and ≥ grade 3 "treatment phase" adverse events (TEAE) were hematologic events, with grade 3/4 anemia accounting for 39.
6%.


Infusion-related reactions occurred in 5 patients (9.
4%), all of which were grade
1/2.

In 6 patients (11.
3%), TEAE occurred, resulting in interruption of
treatment.

Three patients (5.
7%) developed grade 5 TEAE, including pneumonia, acute coronary syndrome, and metabolic acidosis (1 case each), and 1 case of pneumonia was related to
the study drug.

Figure 3

Bone marrow samples from patients who reached CR after ≥ 3 treatment cycles were paired for next-generation sequencing assessment, and genes with significantly reduced mutation burden included TP53, TET2, RUNX1, ASXL1, U2AF1, and SF381 (these genes were associated with poor prognosis of MDS
).

56% of PATIENTS with CR reached MRD negative
.

Conclusions of the study

Lemzoparlimab is well tolerated and effective in combination with AZA, and follow-up of all patients is still ongoing
.

The investigators plan to conduct a randomized phase III trial
in patients with HR-MDS.

Reference: Z.
Xiao, et al.
2022ESMO.
Abstract#617O.

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