BEIJING, June 15, 2026 (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 40 clinical studies of the Company’s novel BTK inhibitor orelabrutinib were presented at the European Hematology Association (EHA) 2026 Congress. Clinical data on the efficacy and safety of orelabrutinib in treatment-naïve (TN) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients from the United States and Europe was released for the first time.
A series of clinical studies on orelabrutinib covered multiple hematological malignancies, including CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and primary central nervous system lymphoma (PCNSL). These findings further support the excellent efficacy and safety of orelabrutinib.
Poster Presentation:
1. Orelabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Safety and Efficacy Results from a Global Phase 1/2 Study. (No. PF610)
This study is to evaluate the safety and efficacy of orelabrutinib in patients with CLL/SLL from the United States and Europe. The researchers include multiple world-renowned oncology centers such as Mayo Clinic. Results are consistent with the prior report in Chinese patients, confirming the efficacy and safety of orelabrutinib for CLL/SLL in a global population.
In evaluable TN CLL/SLL patients (median follow-up 38.1 months), ORR was 100%, with 36-month PFS rate at 94.4% and 36-month OS rate at 100% respectively.
In evaluable R/R CLL/SLL patients (median follow-up 36.8 months), ORR was 86.7%, with 36-month PFS rate 77.9% and the 36-month OS rate 80.1% respectively.
Orelabrutinib demonstrates high kinase selectivity, alleviates off-target inhibition, and reduces cardiovascular, bleeding, and hematologic adverse events.
2. Long-term Follow-up of Orelabrutinib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (No. PF949)
With long-term follow-up, orelabrutinib demonstrated rapid and durable responses, indicating sustained therapeutic benefit in patients with r/r MZL. Importantly, no new safety signals were observed during extended follow-up.
At a median follow-up of 36.8 months, the investigator-assessed ORR was 58.9%, median PFS was 44.4 months, and the 36-month OS rate was 84.7%.
3. Risk-Adapted Management with Obinutuzumab and Orelabrutinib with or without Lenalidomide in Untreated Marginal Zone Lymphoma: First Report of a Prospective, Phase II, Multi-Centre (MAGIC) Study (No. PS2037)
This is a prospective, phase II, multicenter study. The preliminary results demonstrated encouraging efficacy and a manageable safety profile in patients with previously untreated MZL.
Patients with an MZL-IPI score of 0–2 received obinutuzumab plus orelabrutinib (O2 regimen). Those with a score of 3–5 received obinutuzumab, orelabrutinib and lenalidomide (RO2 regimen). In patients who completed six cycles of induction therapy, the CRR was 85.7% and ORR was 95.3% in the O2 group, and the CRR was 71.4% and ORR was 85.7% in the RO2 group.
The study is ongoing, and updated efficacy and safety data will be reported in due course.
4. Polatuzumab Vedotin Combined with Orelabrutinib and Rituximab (PRO Regimen) as Frontline Therapy in Very Elderly and Frail Patients with DLBCL: Updated Results from a Phase II Study (No. PS2072)
Results support the PRO regimen, which includes orelabrutinib, as a feasible strategy for vulnerable patients.
Patients had a median age of 78 years. At the completion of combination therapy, the CR rate was 91.7%. With a median follow-up of 7.0 months, neither the median PFS nor the median OS has been reached. The estimated 9-month PFS rate was 92.8%.
Most other hematologic and non-hematologic toxicities were confined to Grade 1-2 and were clinically manageable with supportive care.
5. The Real-World Efficacy of Bruton’s Tyrosine Kinase Inhibitors Plus High-Dose Methotrexate-Based Induction Treatment for Untreated Primary CNS Lymphoma: A Single-Center Retrospective Analysis (No. PF1035)
This analysis aims to evaluate the efficacy of BTKi like orelabrutinib plus HD-MTX-based chemotherapy regimens as induction treatment for newly diagnosed PCNSL patients in a real-world cohort. The results show that the ORR after induction treatment was 88.6% and the CR rate was 81.1%. There was no significant difference in PFS among the three BTKi, but a significant improvement in OS was observed in the orelabrutinib group (HR 0.26, P=0.016). These results support the use of BTKi-containing treatment regimens as a first-line therapy for PCNSL in clinical practice.
More studies on orelabrutinib have been accepted for poster presentations at the 2026 EHA Congress. Details are listed below:
- Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab Followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (No. PF959)
- Efficacy, Safety, and Genetic Analysis of Orelabrutinib Combined with Rituximab as First-Line Systemic Treatment for Marginal Zone Lymphoma (No. PF951)
- Preliminary Analysis of Orelabrutinib Combined with Obinutuzumab for Marginal Zone Lymphoma (ORION Study) (No. PS2050)
- Preliminary Results of Orelabrutinib Followed by Response-Adapted Ultra-Low-Dose 4Gy Radiotherapy as First-Line Treatment for Localized MALT Lymphoma: A Prospective, Open-Label, Phase II Study (No. PS2053)
- Integrative Transcriptomic Profiling Reveals the Molecular Landscape and Regulatory Drivers of Blastoid Mantle Cell Lymphoma (No. PS1099)
- Bruton Tyrosine Kinase Inhibitor Maintenance Therapy in First-Line Diffuse Large B-Cell Lymphoma: A Multicenter Real-World Study Challenging Conventional Paradigms (No. PS2127)
- Orelabrutinib Plus R-CHOP for the Treatment of Newly Diagnosed Non-GCB Double-Expressor Diffuse Large B-Cell Lymphoma: A Multicenter, Single-Arm, Phase II Study (No. PS2075)
- Large-Scale Real-World Clinical Characteristics and Efficacy of Diffuse Large B-Cell Lymphoma Across Distinct Molecular Subtypes: Interim Data from the BELIEVE Study (No. PF991)
- Clinical Characteristics and Efficacy of MYC/BCL-2 Double-Expressing Diffuse Large B-Cell Lymphoma: Real-World Data from the BELIEVE Study (No. PS2103)
- Orelabrutinib, Rituximab, and Thiotepa (ORT) With or Without High-Dose Methotrexate for Untreated Primary Central Nervous System Lymphoma (No. PS2088)
- Efficacy and Safety of Orelabrutinib Combined with Sintilimab in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (R/R PCNSL): A Prospective Multicenter Phase II Study (No. PS2130)
- Orelabrutinib in Patients with Relapsed or Refractory Primary or Secondary Central Nervous System Lymphoma: A Multicenter, Open-Label, Phase II Study (No. PS2090)
Additionally, more than 20 studies on orelabrutinib were selected for online presentation.
The 2026 EHA Congress is one of the most influential academic conferences in hematology and was held in Stockholm, Sweden.
About InnoCare Pharma
InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.
