2026 ASCO | InnoCare Pharma Announces Multiple Key Data Readouts for Novel BCL2 Inhibitor Mesutoclax

InnoCare Pharma (Hong Kong Stock Exchange: 09969; Shanghai Stock Exchange: 688428) today announced that abstracts for two clinical studies of its internally developed novel BCL2 inhibitor, mesutoclax (ICP-248), have been published on the American Society of Clinical Oncology (ASCO) website. Among them, the study evaluating mesutoclax in myeloid malignancies has been selected for an oral presentation at this year’s ASCO Annual Meeting, while the study in B-cell malignancies will be presented as a poster.

The following data were just released on the ASCO website; updated results from the oral presentation will be disclosed on June 2, Central Time. The data demonstrate that mesutoclax exhibits outstanding efficacy and safety across various hematologic malignancies.

Oral presentation

Safety, Tolerability, and Efficacy of Mesutoclax (ICP-248) in Combination with Azacitidine in Myeloid Malignancies (Abstract #6506)

The study enrolled patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Data indicate that mesutoclax demonstrated favorable safety and efficacy in both MDS and AML treatment.

Among evaluable treatment-naïve MDS patients, the overall response rate (ORR) reached 100% according to the IWG 2006 criteria, with a complete remission rate (CR) of 20% and a marrow complete remission rate (marrow CR) of 80%. Under the IWG 2023 criteria, the composite complete remission rate (composite CR) was 70%, with 30% of patients achieving CR, despite most having received only one cycle of treatment.

Among evaluable treatment-naïve AML patients, the composite complete remission rate (cCR, including CR and CRi) was 85.7%. Of those achieving cCR, 86.7% tested negative for measurable residual disease (MRD) by flow cytometry. According to the 2017 European LeukemiaNet (ELN) classification, the cCR rate in high-risk patients was 75%. The 3-month duration of response (DOR) rate was 91.7%, and the 6-month overall survival (OS) rate reached 94.1%.

In terms of safety, no dose-limiting toxicities (DLTs) or tumor lysis syndrome (TLS) were observed.

Additional study data—including results from patients with relapsed/refractory AML (including those previously treated with and failed BCL2 inhibitors), hematologic recovery status, and data specific to the TP53-mutated population—will be further disclosed following the oral presentation at the ASCO Annual Meeting.

Poster Presentation

Efficacy and Safety of Mesutoclax (ICP-248) in Combination with Orelabrutinib in B-cell Malignancies: A Pooled Analysis (Abstract #7073)

The study enrolled patients with relapsed/refractory mantle cell lymphoma (MCL), relapsed/refractory marginal zone lymphoma (MZL), and treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Data show that the combination of mesutoclax and orelabrutinib demonstrated strong efficacy and safety across these B-cell malignancies, offering a promising new chemotherapy-free, all-oral regimen for patients with B-cell non-Hodgkin lymphomas.

All treatment groups achieved a 100% overall response rate (ORR) and high complete response rates (CRR). Deep responses were observed in all patients receiving mesutoclax 125 mg in combination with orelabrutinib.

Among MCL and MZL patients who completed at least one efficacy assessment, the complete response rates (CRR) were 100% and 50%, respectively. The rate of undetectable minimal residual disease (uMRD) in peripheral blood (PB) was 38.5%.

In the treatment-naïve CLL/SLL cohort, 76.2% of patients had intermediate or high-risk TLS, and 14.3% harbored TP53 mutations or 17p deletion. Among CLL/SLL patients treated with mesutoclax 125 mg, the complete response rate (CRR) was 38.1%, and the peripheral blood undetectable minimal residual disease (uMRD) rate at week 36 reached 65%. The 12-month progression-free survival (PFS) rate for CLL/SLL patients was 100%.

The mesutoclax plus orelabrutinib regimen demonstrated favorable safety and tolerability across all treatment groups. No treatment-emergent adverse events (TEAEs) leading to discontinuation or death were reported, and no cases of tumor lysis syndrome (TLS) occurred.

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.

39K Views