/InnoCare Pharmaceutical Co., Ltd. Multiple data on orelabrutinib were announced at the 18th International Conference on Malignant Lymphoma (ICML)
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InnoCare Pharmaceutical Co., Ltd. Multiple data on orelabrutinib were announced at the 18th International Conference on Malignant Lymphoma (ICML)

InnoCare Pharmaceutical Co., Ltd.
2025/06/20

June 20, 2025, Beijing, China - InnoCare Pharmaceutical Co., Ltd. (Shanghai Stock Exchange Code: 688428; Hong Kong Stock Exchange Code: 09969), a biomedical high-tech company, released multiple data on the new BTK inhibitor Orelabrutinib independently developed at the 18th International Conference on Malignant Lymphoma (ICML) being held in Lugano, Switzerland.

Oral presentation:

Orelabrutinib, lenalidomide, and rituximab combination as first-line treatment of mantle cell lymphoma: final results from the POLARIS multicenter phase II study (Abstract code: 048)

Studies have shown that the combination regimen of orelabrutinib, lenalidomide and rituximab has shown encouraging clinical effects in patients with newly treated mantle cell lymphoma (MCL) and has a good safety profile. It is expected to become an efficient and low-toxic chemotherapy-free regimen.

A total of 29 patients were included in the study, and all patients completed 6 cycles of induction therapy with orbrutinib, lenalidomide, and rituximab, and 22 patients completed maintenance therapy. During the entire study period, the overall response rate (ORR) was 100.0%, with a complete response rate of 89.7% (26 patients) and a partial response rate of 10.3% (3 patients).

Poster presentation 1:

Efficacy, safety and rationality of orelabrutinib combined with otuzumab (O2) in treatment-naïve marginal zone lymphoma (MZL): a prospective cohort study (Abstract code: 255)

This study aimed to explore orelabrutinib combined with outuzumab as a potential first-line treatment option for patients with newly diagnosed MZL, and to evaluate its rationality, effectiveness, and safety by analyzing the characteristics of the tumor microenvironment and the antibody-dependent cell-mediated cytotoxicity (ADCC) mechanism.

During the entire study and induction treatment period, the overall response rate (ORR) was 100%, and 3 patients with partial response (PR) at the end of induction were converted to complete response (CR) during the maintenance period of orelabrutinib monotherapy.

In vitro experiments indicate that orelabrutinib may enhance the efficacy of otuzumab by reducing its inhibitory effect on NK cells.

Poster presentation 2:

Rituximab, high-dose methotrexate plus orelabrutinib as induction therapy for newly diagnosed primary central nervous system lymphoma (Abstract code: 333)

Studies have shown that the induction therapy regimen of rituximab, high-dose methotrexate combined with orelabrutinib shows good anti-tumor activity in newly diagnosed primary central nervous system lymphoma (PCNSL), with a durable, safe and controllable response, providing a potential treatment option for patients with PCNSL.

Among patients who completed 4 cycles of treatment, the overall response rate (ORR) was 98.4% and the complete response (CR) rate was 37.7%. Among patients who received orelabrutinib maintenance therapy, 66.7% remained progression-free, and the 2-year progression-free survival (PFS) and overall survival (OS) rates were 75.0% and 91.7%, respectively.

In addition to the above studies, there are more than 10 studies selected for this ICML conference. For detailed research data, please visit the ICML official website.

As a conference reflecting the current high level of lymphoma research and treatment, the 18th International Conference on Malignant Lymphoma (ICML) will be held in Lugano, Switzerland, from June 17 to 21, 2025.

About InnoCare Pharmaceutical Co., Ltd.

InnoCare Pharmaceutical Co., Ltd. (Shanghai Stock Exchange Code: 688428; Hong Kong Stock Exchange Code: 09969) is a biomedical high-tech company in the commercialization stage, focusing on the development of a new class of new drugs in the field of malignant tumors and autoimmune diseases. The company currently has multiple new drug products in the commercialization, clinical and preclinical development stages. The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.