China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving approval from China’s Center for Drug Evaluation (CDE) to start a Phase II clinical trial assessing a combination of orelabrutinib with tafasitamab and lenalidomide in patients with relapsed/refractory (r/r) non-Hodgkin’s lymphoma (nHL). This approval marks a significant step in InnoCare’s efforts to expand its portfolio for hematological malignancies.
Drug Profile and Development
Orelabrutinib is InnoCare’s in-house discovered Bruton’s tyrosine kinase (BTK) inhibitor. Tafasitamab is a CD19-targeted immunotherapy originated by Xencor Inc., and in-licensed by InnoCare for Greater China development from US-based Incyte Inc. in a 2021 deal. The new trial approval means that InnoCare is expanding development activities as it aims to build a comprehensive portfolio for hematological malignancies.
Clinical Trials and Future Prospects
Alongside this week’s Phase II trial for the combination regimen, InnoCare is also assessing tafasitamab + lenalidomide in a registrational Phase II study for diffuse large B-cell lymphoma (DLBCL). Tafasitamab is already approved in the US (where it is branded Monjuvi) and Europe (branded Minjuvi) for DLBCL in combination with lenalidomide in patients not eligible for stem-cell transplant. InnoCare has secured early access for tafasitamab + lenalidomide via Hainan’s Boao Lecheng International Medical Tourism Pilot Zone for its use in combination with lenalidomide in DLBCL.
Orelabrutinib has already won two conditional approvals from the NMPA in China, for use in r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL), and approval in Singapore for r/r MCL. NHL is a broad hematological cancer category that includes DLBCL, follicular lymphoma, and other lymphoma types. According to the source, there were 92,834 new cases of NHL and 54,351 deaths in 2020 in China.
InnoCare is also developing orelabrutinib for a range of non-oncology diseases, including multiple sclerosis (MS), lupus, and thrombocytopenia. US major Biogen (NSDQ: BIIB) picked up global rights to develop the molecule for MS globally in a USD 930 million deal signed in July 2021. This strategic move underscores InnoCare’s commitment to innovation and addressing significant unmet medical needs in both oncology and non-oncology fields.-Fineline Info & Tech
