2026 ASCO | Key Findings from InnoCare’s Breakthrough BCL2 Inhibitor Mesutoclax Unveiled

(SeaPRwire) –   BEIJING, May 22, 2026 — InnoCare Pharma (HKEX: 09969; SSE: 688428), a biopharmaceutical leader dedicated to oncology and autoimmune disease therapies, announced today that abstracts for two clinical trials involving its novel BCL2 inhibitor, mesutoclax, have been released on the American Society of Clinical Oncology (ASCO) website. The study evaluating mesutoclax for myeloid malignancies has been selected for an oral presentation at the upcoming ASCO annual meeting, while research regarding its use in B-cell malignancies will be featured as a poster presentation.

The data currently available on the ASCO website highlights the strong efficacy and safety profile of mesutoclax across various hematologic cancers, with further updated findings from the oral presentation scheduled for release on June 2 (Central Time).

Oral Presentation

Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies (Abstract No.: 6506)

This study focused on patients diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), with mesutoclax showing promising safety and therapeutic results in both cohorts.

Among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) reached 100% based on IWG 2006 criteria, with 20% achieving complete response (CR) and 80% achieving marrow CR. Under IWG 2023 criteria, the composite CR rate was 70%, including a 30% CR rate observed even after most patients had received only a single treatment cycle.

For evaluable TN AML patients, 85.7% attained a composite CR (cCR, CR+CRi). Of those, 86.7% were found to be Minimal Residual Disease (MRD) negative via flow cytometry. In patients classified as adverse risk per 2017 ELN standards, the cCR was 75%. The 3-month duration of response (DOR) rate was 91.7%, and the 6-month overall survival (OS) rate was 94.1%.

The study reported no instances of dose-limiting toxicity (DLT) or tumor lysis syndrome (TLS).

Additional data, including results for relapsed or refractory (R/R) AML patients—specifically those who previously failed BCL2 inhibitor therapy—as well as findings on hematologic recovery and the TP53-mutated subgroup, will be shared following the oral presentation at the ASCO annual meeting.

Poster Presentation

Efficacy and safety of mesutoclax (ICP-248) in combination with orelabrutinib in patients with B-cell malignancies: A pooled analysis (Abstract No.: 7073)

This trial included patients with R/R mantle cell lymphoma (MCL), R/R marginal zone lymphoma (MZL), and TN chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Results indicate that the combination of mesutoclax and orelabrutinib is both effective and safe, suggesting this all-oral, chemotherapy-free regimen could provide a new treatment pathway for B-cell non-Hodgkin lymphoma.

All treatment cohorts demonstrated a 100% overall response rate (ORR) with high rates of complete response (CRR). Patients treated with 125mg of mesutoclax plus orelabrutinib showed deep responses.

Among MCL and MZL patients with at least one disease evaluation, the CRR was 100% and 50%, respectively, with 38.5% of patients achieving peripheral blood (PB) undetectable MRD (uMRD).

Regarding TN CLL/SLL, 76.2% of patients were at moderate or high risk for TLS, and 14.3% presented with TP53 mutations or del (17p). In the CLL/SLL group receiving 125 mg of mesutoclax, the CRR was 38.1%, and the 36-week peripheral blood uMRD rate was 65%. The 12-month progression-free survival (PFS) rate was 100%.

The combination therapy maintained a manageable safety profile across all groups, with no treatment-emergent adverse events (TEAEs) resulting in death or discontinuation of the drug. No clinical or laboratory TLS was observed.

Note:

1. IWG criteria refers to International Working Group (IWG) response criteria in myelodysplasia.

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

About InnoCare Pharma

InnoCare (HKEX: 09969; SSE: 688428) is a commercial-stage biopharmaceutical firm dedicated to the discovery, development, and commercialization of innovative therapies for cancer and autoimmune diseases, addressing significant global unmet medical needs. The company utilizes advanced drug discovery platforms and maintains a robust pipeline that includes three approved medications (orelabrutinib, tafasitamab, and zurletrectinib), over ten clinical-stage candidates, and various preclinical programs. InnoCare operates across Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more details, visit https://www.innocarepharma.com/en or follow us on LinkedIn.

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