Data of InnoCare’s Orelabrutinib Presented at the 18th International Conference on Malignant Lymphoma (ICML)

Beijing, June 20, 2025 – Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) orelabrutinib were presented at the ongoing 18th International Conference on Malignant Lymphoma (ICML).

Oral Presentation:

Novel Triplet Combination of Orelabrutinib, Lenalidomide, and Rituximab as FrontlineTherapy for Mantle Cell Lymphoma: Final Results of POLARIS Multicenter Phase II Study (Abstract No.: 048)

The study showed that the orelabrutinib, lenalidomide, and rituximab regimen provided an encouraging clinical and molecular response and favorable safety in untreated mantle cell lymphoma (MCL), potentially representing a highly active and less toxic chemotherapy-free option.

29 patients were enrolled. All of them completed 6-cycle orelabrutinib, lenalidomide and rituximab induction, among whom 22 completed maintenance. The study showed the best overall response rate (ORR) of 100.0%, with comlete response (CR) of 89.7% (26 patients) and partial response (PR) of 10.3% (3 patients)

Poster 1：

The Efficacy, Safety, and Rationality of Orelabrutinib Plus Obinutuzumab (O2) in Systemic Treatment-Naive Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: 255)

This study aims to explore the potential first-line treatment option of orelabrutinib in combination with obinutuzumab for treatment-naive marginal zone lymphoma (MZL) patients. By analyzing the characteristics of the tumor microenvironment and the antibody-dependent cell-mediated cytotoxicity (ADCC) mechanism, the rationality, efficacy, and safety of this combination therapy will be evaluated.

Across the entire study and during induction therapy, the overall response rate (ORR) is 100%. Three patients with partial response (PR) after induction therapy achieved complete response (CR) during maintenance.

The ADCC assays showed orelabrutinib in combination with obinutuzumab regimen induced the most active ADCC response in TMD-8 and REC-1 cell lines.

Poster 2：

Rituximab, High-Dose Methotrexate Plus Orelabrutinib as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: 333)

The rituximab, high-dose methotrexate plus orelabrutinib induction regime demonstrated promising anti-tumor activity in newly diagnosed primary central nervous system lymphoma (PCNSL), with a durable response and a manageable safety profile, presenting a potential therapeutic option for PCNSL.

The overall response rate (ORR) was 98.4% in patients who completed four cycles of rituximab, high-dose methotrexate plus orelabrutinib, with 37.7% achieving CR. Of the patients on orelabrutinib maintenance, 66.7% remained progression-free, having 2-year progression-free survival (PFS) and overall response (OS) rates of 75.0% and 91.7%.

Except the above presentations, more than 10 studies were also selected at the meeting. For more detailed clinical data, please refer to ICML website.

As a conference reflecting the high level of research and treatment in lymphoma, the 18th ICML was held in Lugano, Switzerland from June 17 to 21, 2025.

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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