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Orelabrutinib receives approval in China for the treatment of R/R CLL, SLL, and R/R MCL

Jan 6, 2021
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On December 27, 2020, orelabrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, received approval from the Chinese National Medical Products Administration (NMPA) for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and R/R mantle cell lymphoma (MCL).1

This approval was based on data from two phase II clinical trials (NCT03493217 and NCT03494179), which were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.2

Orelabrutinib1,3

  • An orally administered, highly selective, BTK inhibitor for the treatment of cancer and autoimmune diseases.
  • Irreversibly binds to BTK and blocks B-cell receptor signaling, which is crucial for the proliferation and survival of leukemic cells.
  • Currently being investigated as monotherapy in various R/R B-cell malignancies, including CLL, MCL, marginal zone lymphoma, central nervous system lymphoma, and Waldenström’s macroglobulinemia.
  • Also being studied in combination with MIL62, a next-generation CD20 antibody, in patients with follicular lymphoma.

NCT034932172,4

  • A phase I/II, multicenter, open-label study to evaluate the safety and efficacy of orelabrutinib in Chinese patients with R/R CLL (n = 70) or SLL (n = 10).
  • Dosage: 150 mg daily, minimum of 12 cycles.
  • Primary endpoint: objective response rate (ORR) assessed by the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria with modifications or the 2014 Lugano criteria, for CLL and SLL, respectively.
  • Secondary endpoints: duration of response (DOR), progression-free survival (PFS), and safety.

Results2,4

  • With a median follow-up of 14.3 months, the ORR was 91.3% (with 10.0% complete remission, 63.8% partial remission [PR], and 17.5% PR with lymphocytosis).
  • The median DOR and PFS were not yet reached.
  • Most adverse events (AEs) were mild to moderate, with no new safety nor toxicity concerns compared with previous results.
  • The most frequent AEs included thrombocytopenia, neutropenia, anemia, upper respiratory tract infection, pneumonia, and hypokalemia.

NCT034941792,5

  • A phase I/II, multicenter, open-label study to evaluate the safety and efficacy of orelabrutinib in Chinese patients with R/R MCL (n = 106).
  • Primary endpoint: ORR assessed by the 2014 Lugano criteria.
  • Secondary endpoints: DOR, PFS, OS, and safety.
  • Dosage: 100 mg twice daily (n = 20) or 150 mg once daily (n = 86).

Results2,5

  • With a median follow-up of 16.4 months, the ORR was 87.9% (with 34.3% complete remission, 53.5% PR, and 6.1% stable disease).
  • The median DOR and PFS were not yet reached.
  • Grade ≥ 3 treatment-related AEs were reported in 33% of patients and led to a dose reduction or study discontinuation in 6.6% and 2.8% of patients, respectively.
  • The most common AEs included thrombocytopenia, neutropenia, leukopenia, and hypertension.

  1. InnoCare. InnoCare announces the approval of orelabrutinib in China for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and relapsed/refractory mantle cell lymphoma. https://www.innocarepharma.com/en/media/press-release/20201227/. Published Dec 27, 2020. Accessed Jan 5, 2021.
  2. InnoCare. InnoCare presents latest clinical data of orelabrutinib at the 62nd Annual Meeting of ASH. https://cn.innocarepharma.com/en/media/press-release/20201208/. Published Dec 5, 2020. Accessed Jan 5, 2021.
  3. InnoCare. Our pipeline. Orelabrutinib (ICP-022). https://www.innocarepharma.com/en/pipeline/our-pipeline/. Accessed Jan 5, 2021.
  4. Xu W, Song Y, Wang T, et al. Updated results from the phase II study of orelabrutinib monotherapy in Chinese patients with relapsed or refractory chronic lymphocytic leukemia/small cell leukemia. Oral abstract #1320. 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 5, 2020; Virtual.
  5. Song Y, Song Y, Liu L, et al. Long-term safety and efficacy of orelabrutinib monotherapy in Chinese patients with relapsed or refractory mantle cell lymphoma: A multicenter, open-label, phase II study. Poster presentation #2048. 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; Dec 6, 2020; Virtual.

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