| Source: InnoCare Pharma
BEIJING, Dec. 08, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that three studies of its novel BCL2 inhibitor, Mesutoclax (ICP-248), were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Mesutoclax demonstrated remarkable efficacy and a favorable safety profile in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML).
The study of mesutoclax in the treatment of relapsed/refractory MCL was selected for oral presentation, while the CLL/SLL and AML studies were chosen for poster presentations.
Oral Presentation
Title: Efficacy and tolerability of mesutoclax monotherapy in Relapsed/Refractory MCL patients: High remission rates even in prior BTKi-refractory patients (Publication No.: 887)
The clinical data from mesutoclax (ICP-248) monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitors refractory. The overall response rate (ORR) of MCL patients treated with 125 mg mesutoclax monotherapy was 87.5%, with a complete response rate (CRR) of 46.9%. Among MCL patients who were BTK inhibitor refractory, the ORR was 84.0% and the CRR was 36.0%.
Mesutoclax was well tolerated through all dose levels (50-150mg), with no dose-limiting toxicities (DLTs) observed, and maximum tolerated dose (MTD) not reached.
The clinical data of mesutoclax monotherapy showed promising safety and potential Best-in-class efficacy in MCL patients, especially for those who had received multiple prior treatments and were resistant to BTK inhibitors.
Poster 1:
Title: Mesutoclax monotherapy or combined with orelabrutinib demonstrates encouraging activity and safety in patients with CLL/SLL (Publication No.: 5677)
Mesutoclax monotherapy or in combination with orelabrutinib demonstrated a tolerable safety profile across all dose levels tested. Substantial efficacy and deep remission were observed in both treatment-naive (TN) CLL/SLL patients receiving mesutoclax 125mg combined with orelabrutinib and R/R CLL/SLL treated with mesutoclax alone.
In both TN CLL/SLL and R/R CLL/SLL patients (including those who had previously failed BTK inhibitor), the ORR was 100% in the 125 mg mesutoclax dose group. At week 36, when combined with orelabrutinib, the peripheral blood (PB) uMRD rate was 65% at 125 mg. T
Mesutoclax is well tolerated with good safety profile. No DLTs were observed up to 150 mg QD, and MTD was not reached. Most treatment emergent adverse events (TEAEs) were grade 1-2.
Poster 2:
Title: Safety, tolerability and efficacy of mesutoclax to treat patients with myeloid malignancies (Publication No.: 3417)
The combination of mesutoclax and azacitidine (AZA) demonstrated encouraging antitumor activity. The composite CR (CR+CRi, cCR) rate was achieved in 92% of TN AML patients. 82.6% of the patients achieved uMR. Most CR+CRi in TN AML was achieved by the end of cycle 1. Notably, 44% of the treatment naive AML were classified as adverse risk group and median age is 68 years old.
The combination of mesutoclax and AZA also demonstrated well tolerated safety profile. There is no DLT or TLS events during the whole study. The mortality rate within 90 days was 0%.
Mesutoclax further strengthens InnoCare’s pipeline of hematologic oncology products. Two registrational clinical trials are ongoing: one is the combination of mesutoclax and orelabrutinib for the treatment of TN CLL/SLL; the other is for the treatment of MCL that is refractory to BTK inhibitors. In addition, the clinical study of mesutoclax as first-line treatment for AML has entered the dose expansion phase in China and globally, and the clinical study for the treatment of myelodysplastic syndrome (MDS) is being launched globally.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
InnoCare Forward-looking Statements
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