On September 13, 2024 InnoCare reported the latest data of orelabrutinib were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (Press release, InnoCare Pharma, SEP 13, 2024, View Source [SID1234646591]).

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Oral Presentation

A Prospective Study of Orelabrutinib plus Obinutuzumab (O2) in Treatment-naïve Marginal Zone Lymphoma (MZL): Preliminary Analysis on Efficacy and Safety (Abstract No.: 815MO)

This prospective study evaluated a chemotherapy-free regimen of orelabrutinib plus anti-CD20 antibody, obinutuzumab, in treatment-naive MZL.

Currently, there is no well-established standard first-line treatment for symptomatic MZL patients. The preliminary data demonstrated that the combination of orelabrutinib plus obinutuzumab shows promise in treatment-naive MZL. At a median follow-up of 5.4 months, the best objective response rate (ORR) was 100% (57.1% complete response rate (CRR)), with a good safety profile.

Poster Presentation

1. Orelabrutinib-based Regimens in Chronic Lymphocytic Leukemia with Comorbidities: A Real-World Study (Abstract No.: 840P)

This study aimed to evaluate the efficacy of orelabrutinib-based regimens for chronic lymphocytic leukemia (CLL) with comorbidities in a real-world setting. The outcome was the hematologic response (HR) rate. Orelabrutinib-based regimens demonstrated encouraging HR and were well tolerated in CLL with comorbidities, providing valuable insights for clinical management.

Eighty percent of patients have comorbidities. At a median follow-up of 12.7 months, 93.3% patients achieved an HR. Among the different orelabrutinib-based regimens, HR was achieved in 100% of patients receiving orelabrutinib monotherapy and 85.7% of those receiving orelabrutinib + chemotherapy. No serious adverse events occurred in the patients with comorbidities.

2. Efficacy and Safety of Orelabrutinib plus R-CHOP-like Regimens for Treatment-naïve Diffuse Large B-cell Lymphoma with Double Expression (Abstract No.: 819P)

The first-line combination of orelabrutinib plus R-CHOP-like regimens was effective and well-tolerated in patients with diffuse large B-cell lymphoma (DLBCL) harboring double expression.

The complete response rate (CRR) was 93.8% at the end of treatment. After a median follow-up of 13.0 months, the one-year progression-free survival (PFS) and overall survival (OS) rates were 93.3% and 100.0%, respectively.

The following studies were also selected as poster presentations at the ESMO (Free ESMO Whitepaper) Congress 2024.

Fixed-duration Orelabrutinib plus Bendamustine and Rituximab versus Continuous Bruton Tyrosine Kinase Inhibitor (BTKi) in Treatment-naïve Chronic/small Lymphocytic Leukemia (CLL/SLL): A Multicenter, Nonrandomized, Pragmatic Clinical trial (Abstract No.: 846TiP)
Orelabrutinib combined with Rituximab for the Treatment of Elderly patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL) under the guidance of genetic subtype: A prospective, multicenter, single-arm, response-adaptive clinical study (Origin) (Abstract No.: 844TiP)
For more detailed clinical data, please refer to ESMO (Free ESMO Whitepaper) website.

About Orelabrutinib

Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profiles.

On December 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into the National Reimbursement Drug list, allowing it to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition, orelabrutinib is being advanced in autoimmune diseases trials worldwide. A phase III registrational trial for the treatment of Primary Immune Thrombocytopenia purpura (ITP) is ongoing in China. A global phase II study for the treatment of Multiple Sclerosis (MS) has been completed, and a global multi-center phase III study for the treatment of Primary Progressive Multiple Sclerosis (PPMS) is being initiated. A phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, and the patient enrollment in the phase IIb trial is near completion; orelabrutinib is the first and only BTK inhibitor globally to show efficacy in phase II SLE trials. A phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.