I-Mab Announces Positive Phase 2 Data of Lemzoparlimab in Combination with Azacitidine (AZA) in Patients with Higher Risk Myelodysplastic Syndrome at ESMO 2022
- 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 frequency such as TP53, TET2 and RUNX1 were significantly decreased
- A randomized Phase 3 trial in higher-risk MDS is planned
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
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 increased in response to treatment. Of the 29 patients who were dependent upon blood transfusions at baseline, 9 patients (31%) became transfusion independent at the time of analysis. Furthermore, the majority of CR patients showed reduction in variant allele frequency (VAF) of MDS-related gene mutation including TP53, TET2 and RUNX1, with 56% achieving minimal residual disease negativity (≤10-4) by flow cytometry. These data are consistent with the anti-leukemic activities and expected drug safety of lemzoparlimab.
"Without the need of priming dose, the latest Phase 2 data show clinically meaningful efficacy of lemzoparlimab treatment in combination with AZA among patients with newly diagnosed HR-MDS," said Prof. Zhijian Xiao, Professor at
"The clinical activity seen with lemzoparlimab in combination with AZA thus far, in addition to the favorable safety profile, continues to show promise in this difficult-to-treat patient population," said Prof. Chunkang Chang, Director of
"We are excited about the topline data of lemzoparlimab in HR-MDS selected for proffered oral presentation at
The Company is on track to initiate a Phase 3 clinical trial in patients with MDS in
About CD47 and Lemzoparlimab
CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at
Multiple clinical studies of lemzoparlimab are ongoing to explore indications in treating patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), non-Hodgkin's lymphoma (NHL), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors.
I-Mab Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab clinical studies, the potential implications of clinical data for patients, and
Chief Operating Officer
Chief Communications Officer
Office line: +86 21 6039 8363
View original content to download multimedia:https://www.prnewswire.com/news-releases/i-mab-announces-positive-phase-2-data-of-lemzoparlimab-in-combination-with-azacitidine-aza-in-patients-with-higher-risk-myelodysplastic-syndrome-at-esmo-2022-301621532.html