Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia

Pegfilgrastim is indicated for reducing the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy. Here, safety and efficacy of MYL-1401H, a proposed pegfilgrastim biosimilar, were investigated as prophylaxis for chemotherapy-induced neutropenia. T...

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Published in:Annals of hematology 2019-05, Vol.98 (5), p.1217-1224
Main Authors: Waller, Cornelius F., Ranganna, Gopinath M., Pennella, Eduardo J., Blakeley, Christopher, Bronchud, Miguel H., Mattano Jr, Leonard A., Berzoy, Oleksandr, Voitko, Nataliia, Shparyk, Yaroslav, Lytvyn, Iryna, Rusyn, Andriy, Popov, Vasil, Láng, István, Beckmann, Katrin, Sharma, Rajiv, Baczkowski, Mark, Kothekar, Mudgal, Barve, Abhijit
Format: Article
Language:English
Subjects:
Breast cancer
Chemotherapy
Hematology
Medicine
Medicine & Public Health
Neutropenia
Oncology
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Summary:Pegfilgrastim is indicated for reducing the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy. Here, safety and efficacy of MYL-1401H, a proposed pegfilgrastim biosimilar, were investigated as prophylaxis for chemotherapy-induced neutropenia. This was a phase 3, multicenter, randomized, double-blind, parallel-group equivalence trial of MYL-1401H vs European Union–sourced reference pegfilgrastim. Patients with newly diagnosed stage II/III breast cancer eligible to receive (neo) adjuvant chemotherapy with docetaxel/doxorubicin/cyclophosphamide every 3 weeks for 6 cycles were enrolled and randomized 2:1 to 6 mg of MYL-1401H or reference pegfilgrastim 24 h (+ 2-h window after the first 24 h) after the end of chemotherapy. The primary efficacy endpoint was the duration of severe neutropenia in cycle 1 (i.e., days with absolute neutrophil count (ANC)
ISSN:0939-5555
1432-0584
DOI:10.1007/s00277-019-03639-5