2026 EHA | Over 40 studies on orelabrutinib presented, including first-time clinical data on orelabrutinib for treatment-naïve CLL/SLL patients in Europe and the U.S.

InnoCare Pharma (HKEX: 09969; SSE: 688428) today announced that over 40 studies on its independently developed novel BTK inhibitor, orelabrutinib, are being presented at the 31st European Hematology Association (EHA) Annual Meeting, marking the first presentation of clinical data demonstrating the efficacy and safety of orelabrutinib in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients from Europe and the United States.

The orelabrutinib research program spans multiple hematologic 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 strong efficacy and favorable safety profile of orelabrutinib.

Poster Presentation

1. Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Safety and Efficacy Results from a Global Phase I/II Study (Poster Number: PF610)

This study evaluated the safety and efficacy of orelabrutinib in CLL/SLL patients in Europe and the U.S., with investigators from multiple internationally renowned oncology centers, including Mayo Clinic. The results align with prior data from Chinese patients, further confirming the efficacy and safety of orelabrutinib in treating CLL/SLL across diverse populations.

Results showed that among evaluable treatment-naïve CLL/SLL patients (median follow-up: 38.1 months), the objective response rate (ORR) was 100%, the 36-month progression-free survival (PFS) rate was 94.4%, and the 36-month overall survival (OS) rate was 100%.

Among evaluable relapsed/refractory CLL/SLL patients (median follow-up: 36.8 months), the ORR was 86.7%, the 36-month PFS rate was 77.9%, and the 36-month OS rate was 80.1%.

In terms of safety, orelabrutinib demonstrated high kinase selectivity, reducing off-target inhibition and lowering the incidence of cardiovascular, bleeding, and hematologic adverse events.

2. Long-term follow-up of orelabrutinib in patients with relapsed/refractory marginal zone lymphoma (Poster ID: PF949)

With extended follow-up, orelabrutinib monotherapy demonstrated rapid onset of action and sustained responses, offering long-term survival benefits for patients with relapsed/refractory marginal zone lymphoma (r/r MZL). Importantly, safety remained favorable during the extended follow-up period, with no new safety signals observed.

Results showed that, based on investigator assessment (median follow-up: 36.8 months), the ORR was 58.9%, median PFS was 44.4 months, and the 36-month OS rate was 84.7%.

3. Orelabrutinib plus obinutuzumab with or without lenalidomide in previously untreated marginal zone lymphoma patients with different risk profiles: First report from the prospective, phase II, multicenter MAGIC study (Poster ID: PS2037)

This study is a prospective, multicenter, phase II clinical trial. Preliminary results indicated that this regimen demonstrated excellent efficacy and manageable safety in treatment-naïve marginal zone lymphoma patients.

Patients were divided into two groups: those with a Marginal Zone Lymphoma International Prognostic Index (MZL-IPI) score of 0–2 received orelabrutinib plus obinutuzumab (O2 regimen), while those with an MZL-IPI score of 3–5 received the triplet regimen of orelabrutinib, obinutuzumab, and lenalidomide (RO2 regimen). After six cycles of induction therapy, the complete response rate (CRR) in the O2 group was 85.7%, with an ORR of 95.3%; in the RO2 group, the CRR was 71.4% and the ORR was 85.7%.

The research is currently ongoing, and updated efficacy and safety data will be released subsequently.

4. Polatuzumab vedotin combined with orelabrutinib and rituximab (PRO regimen) as first-line treatment for elderly or frail patients with diffuse large B-cell lymphoma (DLBCL): Updated results from a Phase II study (Poster ID: PS2072)

Study findings confirm that the PRO regimen containing orelabrutinib is an effective and well-tolerated first-line treatment option for elderly or frail patients with DLBCL.

The median age of enrolled patients was 78 years. After six cycles of the PRO regimen, the complete response (CR) rate was 91.7%. With a median follow-up of 7 months, more than half of the patients remained alive without disease progression, and the estimated 9-month progression-free survival (PFS) rate was 92.8%.

The majority of hematologic and non-hematologic toxicities were grade 1–2 and were effectively managed with supportive care.

5. Real-world efficacy of BTK inhibitors combined with high-dose methotrexate in previously untreated primary central nervous system lymphoma (PCNSL): A single-center retrospective analysis (Poster ID: PF1035)

This study aimed to evaluate the real-world efficacy of induction therapy with BTK inhibitors such as orelabrutinib combined with high-dose methotrexate in patients with previously untreated primary central nervous system lymphoma (PCNSL). Results showed an overall response rate (ORR) of 88.6% and a complete response (CR) rate of 81.1% after induction therapy. Although no significant difference in progression-free survival (PFS) was observed among the three BTK inhibitors, a significant improvement in overall survival (OS) was noted in the orelabrutinib group (HR = 0.26, P = 0.016). These findings strongly support the use of regimens containing BTK inhibitors like orelabrutinib as first-line therapy for PCNSL.

In addition, several other studies involving orelabrutinib have been selected for poster presentation at the 2026 EHA Annual Meeting, as detailed below:

1. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance in previously untreated marginal zone lymphoma (OPTIMIZE): A multicenter, single-arm, Phase II study (Poster ID: PF959)

2. Efficacy, safety, and genetic analysis of orelabrutinib plus rituximab as first-line systemic therapy for marginal zone lymphoma (Poster ID: PF951)

3. Preliminary analysis of orelabrutinib combined with obinutuzumab in the treatment of marginal zone lymphoma (ORION study) (Poster ID: PS2050)

4. Preliminary results of orelabrutinib followed by ultra-low-dose (4 Gy) radiotherapy with adaptive response-guided dose adjustment as first-line treatment for localized mucosa-associated lymphoid tissue (MALT) lymphoma: a prospective, open-label, phase II study (Poster ID: PS2053)

5. Integrated transcriptomic profiling reveals molecular characteristics and regulatory mechanisms of blastoid variant mantle cell lymphoma (Poster ID: PF1099)

6. BTK inhibitor maintenance therapy in frontline diffuse large B-cell lymphoma: a multicenter real-world study challenging conventional paradigms (Poster ID: PS2127)

7. Orelabrutinib combined with R-CHOP in previously untreated non-GCB double-expressor diffuse large B-cell lymphoma: a multicenter, single-arm, phase II study (Poster ID: PS2075)

8. Real-world clinical features and outcomes across molecular subtypes of diffuse large B-cell lymphoma: interim data from the BELIEVE study (Poster ID: PF991)

9. Clinical features and outcomes in MYC/BCL-2 double-expressor diffuse large B-cell lymphoma: real-world data from the BELIEVE study (Poster ID: PS2103)

10. Orelabrutinib, rituximab, and thiotepa (ORT), with or without high-dose methotrexate, in previously untreated primary central nervous system lymphoma (Poster ID: PS2088)

11. 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 (Poster ID: PS2130)

12. Orelabrutinib in patients with relapsed or refractory primary or secondary central nervous system lymphoma: a multicenter, open-label, phase II study (Poster ID: PS2090)

Additionally, more than 20 studies on orelabrutinib have been selected for online presentation.

The 2026 EHA Congress will be held in Stockholm, Sweden, and is one of the most prominent academic conferences in the field of hematology.

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