en.Wedoany.com Reported - InnoCare Pharma (HKEx: 09969; SSE: 688428) presented updated clinical data on its novel BCL2 inhibitor Mesutoclax (ICP-248) in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. The data demonstrated favorable efficacy and safety in treatment-naïve patients.

Among evaluable treatment-naïve (TN) MDS patients, as of April 20, 2026, the overall response rate (ORR) reached 100% per IWG 2006 criteria (International Working Group response criteria for myelodysplasia), with a complete remission (CR) rate of 40% and a marrow CR rate of 60%. Per IWG 2023 criteria, the composite CR rate was 90%, with a CR rate of 60%.

Among evaluable treatment-naïve AML patients, as of April 13, 2026, 81.8% achieved composite CR (cCR, including CR and CR with incomplete blood count recovery CRi), and 86.5% achieved minimal residual disease (MRD) negativity. Among responders achieving cCR, 83% achieved remission in the first treatment cycle. In the 125mg Mesutoclax cohort, the 6-month duration of response (DOR) rate was 93.3%, and the overall survival (OS) rate was 90.5%. For treatment-naïve AML patients with TP53 mutations, the cCR rate was 71.4%, with a 6-month DOR rate exceeding 50%.

In terms of 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. The 30-day and 60-day mortality rates for treatment-naïve AML patients were both 0%.

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