Beijing, June 12, 2023 - Data of InnoCare’s (HKEX: 09969; SSE: 688428) robust pipelines were presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
Orelabrutinib, an irreversible inhibitor of Bruton’s Tyrosine Kinase, for treatment of Primary Immune Thrombocytopenia: results of a Randomized, Open-label Phase II Study
Abstract Number: S299
This study is aiming to evaluate the efficacy, safety and tolerability of orelabrutinib in patients with persistent or chronic primary immune thrombocytopenia (ITP). The primary endpoint was the percentage of patients who achieved at least two consecutive platelet counts ≥50x109/L without rescue medication in the 4 weeks before the elevated platelet count.
As of cut-off date on 6 Feb 2023, 33 patients were enrolled. Both 50mg QD and 30mg QD of orelabrutinib were safe in the treatment of patients with ITP. Generally, patients with orelabrutinib 50mg QD responded rapidly with better efficacy, especially in those who had responded to previous glucocorticoids (GC) / intravenous immunoglobulin (IVIG) therapies.
Overall 36.4% (12/33) patients met the primary endpoint, 40% (6/15) at the 50mg arm reached primary endpoint. Among 12 patients with primary endpoint response, 83.3% (10/12) patients achieved durable response defined as the percentage of patients with platelet count ≥50x109/L for at least 4 of the 6 visits between 14-24 weeks.
Among the 22 patients with previous response to GC or IVIG, 75.0% at the 50mg arm achieved the primary endpoint.
Orelabrutinib was safe in the treatment of ITP. Treatment related adverse events (TRAEs) were grade 1 or 2.
Poster Presentation 1:
ORIENT study: regimen of orelabrutinib plus R-CHOP-like for patients with newly diagnosed untreated non-GCB DLBCL
Abstract Number: P1196
This study aimed to analyze efficacy and safety of orelabrutinib plus R-CHOP-like for untreated non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) patients who benefited from induction therapy of orelabrutinib plus rituximab.
Despite preliminary, orelabrutinib+rituximab achieved high adaptability response in a short-term treatment for newly diagnosed non-GCB DLBCL. Orelabrutinib+R-CHOP regimen achieved high complete remission rates and demonstrated favorable safety profiles in patients who benefited from orelabrutinib+rituximab induction therapy.
Poster Presentation 2:
Preliminary Findings of A Phase II study of Chemo-free combination of Pomalidomide, Orelabrutinib, Rituximab with Sequential high-dose Methorexate in Newly Diagnosed Primary CNS Lymphoma
Abstract Number: P1165
This is the first study to treat newly diagnosed primary central nervous system lymphoma (PCNSL) with a targeted therapy combination before chemotherapy. Pomalidomide, orelabrutinib and rituximab produced a high overall response rate (ORR) with good tolerance. This suggested the potential of noncytotoxic first-line therapies for PCNSL.
Detailed abstracts can be found at EHA official website.
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
On Dec. 25, 2020, orelabrutinib received conditional 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 National Reimbursement Drug list 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 to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of Phase II registrational trial for R/R MCL was completed in the U.S.
In addition, orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.
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 cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.