Over 20 Studies of InnoCare’s Orelabrutinib Presented at the 67th Annual Meeting of the American Society of Hematology (ASH)

BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67^th Annual Meeting of the American Society of Hematology (ASH).

Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL).

Oral Presentation

Mid-treatment CSF ctdna and MYD88 clearance outperform PET-CT in predicting response and survival to orelabrutinib-based induction in newly diagnosed PCNSL: A prospective biomarker study (Publication No.: 59)

The orelabrutinib, rituximab, and high-dose methotrexate (ORM) induction is effective and well tolerated in newly diagnosed PCNSL. Early cerebrospinal fluid (CSF) ctDNA and MYD88 clearance at mid-treatment offer superior predictive and prognostic value compared to PET-CT. These molecular biomarkers enable real-time risk stratification and may guide early treatment adaptation. Incorporating CSF ctDNA monitoring into clinical workflows has the potential to improve response prediction and long-term outcomes in PCNSL.

Post-cycle 6, objective response rate (ORR) was 89.5%, with 78.9% complete response rate (CR). Median time to response was 2.6 months; 2-year duration of response (DoR) 72.4%. Median follow-up was 18.9 months; estimated 2-year progression-free survival (PFS) and overall survival (OS) were 62.5% and 75.2%, respectively. Treatment was generally well tolerated.

Poster

1.   Preliminary analysis of orelabrutinib combined with obinutuzumab in the treatment of marginal zone lymphoma (Orion Study) (Publication No.: 5379)

Orelabrutinib combined with obinutuzumab demonstrated promising antitumor activity in treatment-naïve MZL with no severe toxicities observed. These early results support orelabrutinib combined with obinutuzumab regimen as a potential chemotherapy-free first-line option for MZL.

Among 27 efficacy-evaluable patients: 25 patients completed interim assessment: ORR 96.0%, CR rate 72.0%; 10 patients completed 6 cycles assessment: ORR 100%, CR rate 70.0%.

2.   Preliminary study results of orelabrutinib in combination with rituximab for treatment-Naïve marginal zone lymphoma: A prospective single-arm clinical trial (Publication No.: 3580)

Orelabrutinib combined with rituximab demonstrates promising preliminary efficacy in treatment-naïve MZL patients who failed or were unsuitable for local therapy, with an ORR of 81.8% and a CRR of 72.7%.

Despite current limitations of small sample size and short median follow-up, the orelabrutinib in combination with rituximab regimen represents a promising chemotherapy-free option for these patients.

3.   Orelabrutinib plus bendamustine-rituximab (OBR) versus bendamustine-rituximab (BR) in transplant-ineligible, intermediate- to high-risk Mantle Cell Lymphoma (MCL) (Publication No.: 3599)

The orelabrutinib plus bendamustine-rituximab regimen demonstrated a promising tumor response and favorable survival outcomes compared to the bendamustine-rituximab regimen. These findings suggest that the OBR regimen may serve as a promising treatment option for patients with transplant-ineligible, intermediate- to high-risk MCL.

4.   Practice pattern and outcomes in DLBCL by Genetic Subtypes: Preliminary results from a large-scale real-world study in China (Publication No.: 3689)

This large-scale real-world study provides treatment patterns and outcomes across DLBCL genetic subtypes in China. Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) plus BTKi demonstrated enhanced efficacy in MCD-like patients, supporting subtype-directed therapy. Updated survival and safety data will be presented.

R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like subgroup.

5.   Pomalidomide, rituximab, and orelabrutinib in combination with polatuzumab vedotin for newly diagnosed diffuse large B-cell lymphoma in elderly, unfit, or frail patients: a prospective phase II study (Publication No.: 1912)        

The preliminary results suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail patients with DLBCL, exhibiting promising efficacy and an acceptable safety profile - particularly in those who responded to PRO induction therapy.

Among the patients completed ≥3 cycles of treatment, CRR and ORR reached 77.8% and 100.0% respectively. Among the patients who completed all 6 cycles of treatment, both the CRR and ORR reached 100.0%.

Publication Only:

Efficacy and safety of orelabrutinib monotherapy in patients with chronic lymphocytic leukemia: A retrospective real-world study (Abstract ID: abs25-8605)

This real-world study suggested that orelabrutinib monotherapy showed promising efficacy and a favorable safety profile in patients with CLL, both as first-line and subsequent therapy. Patients receiving first-line orelabrutinib achieved both an ORR and DCR of 100%.

More studies on orelabrutinib have been selected for poster presentation and publication only at the 2025 ASH Annual Meeting. The other studies selected for poster presentation are as follows:

1. Efficacy and safety of orelabrutinib, obinutuzumab, and lenalidomide in previously untreated marginal zone lymphoma: Preliminary results from a prospective, single-arm, multicenter, Phase II study (Publication No.: 5383)
2. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance in untreated marginal zone lymphoma (Optimize): A multicenter, single-arm, phase II study (Publication No.: 3596)
3. Real-world efficacy and safety of orelabrutinib-based regimens in the treatment of marginal zone lymphoma (Publication No.: 1817)
4. Single-cell transcriptomic profiling reveals tumor-intrinsic heterogeneity and immunemicro environment dynamics in the order trial for mantle-cell lymphoma (Publication No.: 1792)
5. Orelabrutinib combined with R-CDOP regimen for first-line treatment of diffuse large Bcell lymphoma with high-risk CNS-IPI (Publication No.: 5460)
6. Preliminary result of first-line orelabrutinib plus R-CHOP in CD5-positive diffuse large B-cell lymphoma (Rocket trial): A single-arm, phase II trial (Publication No.: 3690)
7. Exploration of optimal high-dose methotrexate-based therapy for patients with primary CNS lymphoma: A real-world study in China (Publication No.: 3693)
8. Chemotherapy-free induction with pomalidomide, orelabrutinib, and rituximab (POR) followed by high-dose methotrexate,rituximab and orelabrutinin (ROM) in newly diagnosed primary CNS lymphoma: Interim analysis of a phase II study (Publication No.: 5471)
9. Orelabrutinib plus anti-PD-1 antibody and fotemustine for newly diagnosed primary central nervous system lymphoma: Phase I/II results (Publication No.: 5465)
10. Orelabrutinib, rituximab, and thiotepa (ORT) in combination with or without high-dose methotrexate in untreated primary central nervous system lymphoma (Publication No.: 1911)
11. Primary efficacy and safety of first-line R-MTO regimen (rituximab, methotrexate, thiotepa, and orelabrutinib) followed by autologous hematopoietic stem cell transplantation in PCNSL (Publication No.: 3687)
12. Orelabrutinib, sintilimab, and temozolomide (OST) in relapsed/refractory primary central nervous system lymphoma (Publication No.: 5461)

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.

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