2026 ASCO | InnoCare Pharma Announces Pivotal Oral Presentation Data for Mesutoclax, a Novel BCL2 Inhibitor, in MDS and AML

InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced that the latest data from its independently developed novel BCL2 inhibitor mesutoclax (ICP-248) in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) were presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, under the title "Safety, Tolerability, and Efficacy of Mesutoclax in Combination with Azacitidine in Myeloid Malignancies," demonstrating outstanding efficacy and safety.

Professor Wang HuaFeng from the First Affiliated Hospital of Zhejiang University School of Medicine delivered an oral presentation at the ASCO conference

As of April 20, 2026, among evaluable treatment-naïve MDS patients,the overall response rate (ORR) reached 100%, with a complete remission (CR) rate of 40%and a bone marrow complete remission (marrow CR) rate of 60%. According to the IWG 2023 criteria, the composite complete remission (composite CR) rate was 90%, with 60% of patients achieving CR.

As of April 13, 2026, among evaluable treatment-naïve AML patients,the composite complete remission rate (cCR, including CR and CRi) was 81.8%, with 86.5% of responding patients testing negative for minimal residual disease (MRD)Among patients achieving cCR, 83% attained cCR during the first cycle, indicating that the mesutoclax regimen enables faster and deeper remissions. In the 125 mg mesutoclax dose group, the 6-month duration of response (DOR) rate was 93.3%, and the 6-month overall survival (OS) rate reached 90.5%. In treatment-naïve AML patients with TP53 mutations, the cCR rate was 71.4%, with a 6-month DOR exceeding 50%.

Regarding safety, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Most non-hematologic adverse events were grade 1 or 2. Due to the potent efficacy, cytopenias resolved rapidly. In treatment-naïve AML patients, early mortality (at 30 and 60 days) was 0%.

Note:

1. The IWG criteria refer to the International Working Group criteria for response in myelodysplastic syndromes.

2. CRi refers to complete remission with incomplete hematologic recovery.

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