- Lemzoparlimab combined with AZA showed encouraging clinical response in higher-risk MDS patients
- For patients received initial dose over 3 months, the ORR is 80.6% and for patients received initial dose over 6 months the ORR is 86.7%, CR rate 40%
- Lemzoparlimab does not require priming dosing with no unexpected safety signals in combination therapy with AZA
- For subjects achieving CR, remaining gene mutation frequencies such as TP53, TET2 and RUNX1 were significantly decreased
- A randomized Phase 3 trial in higher-risk MDS is planned
GAITHERSBURG, Md. and SHANGHAI, Sept. 10, 2022 /PRNewswire/ — I-Mab (the “Company”) (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announces encouraging data from its Phase 2 clinical trial (NCT04202003) of lemzoparlimab (also known as TJC4) in combination with azacitidine (AZA) in patients with newly diagnosed higher risk myelodysplastic syndrome (HR-MDS), presented in an oral presentation on September 10 at the European Society for Medical Oncology (ESMO) Congress 2022.
The open-labeled Phase 2 clinical trial is designed to investigate the efficacy and safety of lemzoparlimab in combination with AZA in patients with newly diagnosed HR-MDS. A total of 53 patients were enrolled as of March 31, 2022, receiving lemzoparlimab at a weekly dose of 30 mg/kg intravenously (IV) and AZA at 75 mg/m2 subcutaneously (SC) on Days 1–7 in a 28-day cycle.
Top-line data showed that for patients who began treatments 6 months or longer prior to the analysis (n=15), the overall response rate (ORR) and complete response rate (CRR) was 86.7% and 40% respectively. For patients who began treatment 4 months or longer prior to the analysis (n=29), the ORR and CRR was 86.2% and 31% respectively. While the study enrolled more patients with worse baseline conditions due to underlying disease (74% of patients had grade ≥ 3 anemia and 51% of patients had grade ≥3 thrombocytopenia), the results showed that lemzoparlimab combined with AZA was well-tolerated and the safety profile was consistent with AZA monotherapy.
Decreased red blood cells, measured as hemoglobin, and decreased platelets are major causes of morbidity for patients with HR-MDS and the median hemoglobin and platelet levels for patients on study …